Fosfatase Ácida Targa - Kovalent · ALAT (GPT) FS (IFCC mod.) Order information Cat. No. 1 2701 .....

Targa

INSTRUMENT PARAMETER

Método (Redutor) Cinética

Soro Starter (Inativa) Filtros (A/B) 405 Units U/l Tipo de método Com Fator Metodologia Alfa Naftil Number of needle washes

1

Tempo de retardo (Sec) 200 Inc. Reagentes (Sec) 60 Tempo de leitura (Sec) 60 Limite de Reação (mABS) 300 Max ABS Delta (mABS) 800 Limite Reagente (mABS) 250 Reagents A/B (l) 300

Direção da Reação Crescente Diluição Reagente 1:1 ABS Inicial (mABS) 0.000 Aceitabilidade Curva 100% Perfil Automático (inativo) Rept. Branco Reag. H:M 00:00 Branco Dinâmico (Inativo) Repetição Patológicos (Inativo)

Parametros do soro Nome do teste Fosf. Ac. Prost. Vol. Amostra (l) 30

Fator de Diluição 1:1 Linearidade 5:00 Min. Max. H. 0.000/ 3.70 Min. Max. M. 0.000/ 0.000 Min. Max. N 0.000/ 0.000 Parametros de urina Nome do teste Vol. de Urina (l) 1

Linearidade 5.00 Min. Max. H. 0.000 / 0.000 Min. Max. M. 0.000 / 0.000 Min. Max. N. 0.000 / 0.000 Diluição Automát. Inativa Multi Fator 1.00 Fator Unidades 1.00

Fosfatase Ácida

Artigo Apresentação 12660 R1 1 x 32 ml – Solução Tampão R2 16 x 2 ml – Substrato R3 1 x 32 ml – Solução Tartarato R4 1 x 2 ml - Estabilizadores

Notas: 1. Por favor, recorra a Bula da Fosfatase Ácida para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método

- Valores de referência - Literatura

2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação. Produzido por: Rolf Greiner BioChemica GmbH Bahnhofstrabe 32, 65558 Flacht, Germany Importado e distribuido po BioSys LTDA.

Targa BT 3000


Test Typ Kinetic With Starter

Serum Starter Active Filters (A/B) 578 Units U/l Test Method with Factor Test Methodology Kin Number of washes I Delay Time (Sec) 180 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 300 Reaction Limit (mABS) 2500 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 1000 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name Lipase Sample Volume (l) 5

Dilution Ratio 1:4 Min. Max. M. 0/60 Min. Max. F. Min. Max. B.

Urine Parameters Tests Name Urine Volume (l)

Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution Multi Factor

LIPASE DC FS

Order information Cat. No. Kit size 1 4321 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml

1 4321 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 4321 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for Lipase DC FS for detailed

information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided. 3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

April 2010/1

TARGA 3000

Analytical parameters Test ALAT

Test methodology UV Method Kinetic Kind of process Linear Filter 340 Reaction direction Decreasing Reagent#1 240 µl Reagent#2 60 µl Sample Start Active Delay time (Sec) 60 Incubation time (Sec) 0 / 10 Reading time (Sec) 60 Unit Serum U/L Unit Urine Number of needle washes 2/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every day Reagent Limit (mABS) 3500 Curve Acceptance (%) 100

Serum

Name ALAT Sample µl 30 Pre-Dilution 1.00

Dilution

Factor 4.00 Test Limit (Conc) 600 Initial Delta (mABS) 2000 Final Delta (mABS) 2000 Delta ABS Max (mABS) 100000 Verify prozone Inactive Instrumental Factor 1.000 Shift 0.000 Re-run hyperactive Inactive Re-run pathological Inactive Re-run above the curve Inactive Re-run below the curve Inactive

Normal Range

Man # / # Woman # / # Child # / #

Urine


Dilution

Factor 1.00 Test Limit (Conc) 0 Max ABS Delta (mABS) 2000 Re-run hyperactive Inactive Re-run pathological Inactive

Normal Range

Man # / # Woman # / # Child # / #

#) Data entry by the user

ALAT (GPT) FS (IFCC mod.)

Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT (GPT) FS

(IFCC mod.) for detailed information about the test on the following:




2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by


**This application proposal is for guidelines only. To avoid

misinterpretation measured results have to be validated and

assessed with caution

April 2010/1

TARGA 3000 Monoreagent application Analytical parameters Test ALAT

Test methodology UV Method Kinetic Kind of process Linear Filter 340 Reaction direction Decreasing Reagent#1 300 µl Reagent#2 0 Sample Start Active Delay time (Sec) 0 Incubation time (Sec) 100 Reading time (Sec) 90 Unit Serum U/L Unit Urine Number of needle washes 2/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every day Reagent Limit (mABS) 3500 Curve Acceptance (%) 100

Serum


Dilution


Normal Range

Man # / # Woman # / # Child # / #

Urine


Dilution


Normal Range

Man # / # Woman # / # Child # / #


ALAT (GPT) FS (IFCC mod.)

Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT (GPT) FS







3. Manufactured by





January 2008/1

TARGA 3000

Analytical parameters Test MALB

Test methodology Turbidimetric Method Sample Blank (A) Kind of process Cubic Spline Filter 405 Reaction direction Increasing Reagent#1 350 µl Reagent#2 70 µl Sample Starter Inactive Delay time (Sec) 0 Incubation time (Sec) 300/300 Reading time (Sec) 300 Unit Serum mg/l Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name MALB Sample µl 3 Pre-Dilution 20.00

Dilution

Factor 1.00 Test Limit (Conc) 350 Max ABS Delta (mABS) 1000 Check prozone Inactive Re-run hyperactive Inactive Re-run pathological Inactive Re-run out of curve ‘Above Inactive Re-run out of curve ‘Below’ Inactive

Normal Range

Man # Woman # Child #

Urine

Name MALB Sample µl 20 Pre-Dilution 1.00

Dilution

Factor 1.00 Test Limit (Conc) 350 Max ABS Delta (mABS) 1000 Check prozone inactive Re-run hyperactive Inactive Re-run pathological Inactive Re-run out of curve ‘Above Inactive Re-run out of curve ‘Below’ Inactive

Normal Range

Man # Woman # Child #


ALBUMIN IN URINE/CSF FS (Microalbumin)

Urine/CSF application

Order information

Cat. No. 1 0242 .. .. …

Notes

1. Please refer to the package insert for Albumin in Urine/CSF

FS *Microalbumin for detailed information about the test on the following:






3. Manufactured by





April 2010/1

TARGA 3000

Analytical parameters Test ASAT

Test methodology UV Method Kinetic Kind of process Linear Filter 340 Reaction direction Decreasing Reagent#1 240 µl Reagent#2 60 µl Sample Start Active Delay time (Sec) 60 Incubation time (Sec) 0 / 10 Reading time (Sec) 60 Unit Serum U/L Unit Urine Number of needle washes 2/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every day Reagent Limit (mABS) 3500 Curve Acceptance (%) 100

Serum

Name ASAT Sample µl 30 Pre-Dilution 1.00

Dilution


Normal Range

Man # / # Woman # / # Child # / #

Urine


Dilution


Normal Range

Man # / # Woman # / # Child # / #


ASAT (GOT) FS (IFCC mod.)

Order information

Cat. No. 1 2601 .. .. …

Notes

1. Please refer to the package insert for ASAT (GOT) FS







3. Manufactured by





April 2010/1

TARGA 3000 Monoreagent application Analytical parameters Test ASAT

Test methodology UV Method Kinetic Kind of process Linear Filter 340 Reaction direction Decreasing Reagent#1 300 µl Reagent#2 0 Sample Start Active Delay time (Sec) 0 Incubation time (Sec) 100 Reading time (Sec) 90 Unit Serum U/L Unit Urine Number of needle washes 2/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every day Reagent Limit (mABS) 3500 Curve Acceptance (%) 100

Serum


Dilution


Normal Range

Man # / # Woman # / # Child # / #

Urine


Dilution


Normal Range

Man # / # Woman # / # Child # / #


ASAT (GOT) FS (IFCC mod.)

Order information

Cat. No. 1 2601 .. .. …

Notes

1. Please refer to the package insert for ASAT (GOT) FS







3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Test ASO

SAMPLE STARTER

Test methodology Turbidimetric Method Fixed time Kind of process Cubic Spline Filter 578 / -.- Reaction direction Increasing Reagent#1 250 µl Reagent#2 50 µl

Sample Starter active Delay time (Sec) 5 Incubation time (Sec) 0/0 Reading time (Sec) 300 Unit Serum IU/ml Unit Urine Number of needle washes 2/1 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 2500 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name ASO Sample µl 6 Pre-Dilution 1.00

Dilution


Normal Range

Man ** Woman ** Child **

Urine

Name Sample µl Pre-Dilution

Dilution

Factor Test Limit (Conc) Max ABS Delta (mABS) Re-run hyperactive Re-run pathological

Normal Range

Man Woman Child


ANTISTREPTOLYSIN O FS

Order information

Cat. No. 1 7012 .. .. …

Notes

1. Please refer to the package insert for Antistreptolysin O FS

for detailed information about the test on the following:






3. Manufactured by





January 2010/1

TARGA 3000

Analytical parameters Test C3

Test methodology Turbidimetric Method Sample Blank (A) Kind of process Cubic Spline Filter 340 Reaction direction Increasing Reagent#1 350 µl Reagent#2 70 µl Sample Starter Inactive Delay time (Sec) 0 Incubation time (Sec) 300/300 Reading time (Sec) 300 Unit Serum mg/dl Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name C3 Sample µl 6 Pre-Dilution 1.00

Dilution


Normal Range

Man 0 /# Woman 0 /# Child 0 /#

Urine


Dilution

Factor 1.00 Test Limit (Conc) 0.0 Check prozone inactive Re-run hyperactive Inactive Re-run pathological Inactive

Normal Range

Man Woman Child


COMPLEMENT C3C FS

Order information

Cat. No. 1 1802 .. .. …

Notes

1. Please refer to the package insert for Complement C3c FS







3. Manufactured by





January 2010/1

TARGA 3000

Analytical parameters Test C4

Test methodology Turbidimetric Method Sample Blank (A) Kind of process Cubic Spline Filter 340 Reaction direction Increasing Reagent#1 350 µl Reagent#2 70 µl Sample Starter Inactive Delay time (Sec) 0 Incubation time (Sec) 300/300 Reading time (Sec) 300 Unit Serum mg/dl Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum


Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


COMPLEMENT C4 FS

Order information

Cat. No. 1 1812 .. .. …

Notes

1. Please refer to the package insert for Complement C4 FS







3. Manufactured by





June 2004/2

TARGA 3000

Analytical parameters Test CRP

Test methodology Turbidimetric Method End Point Kind of process Cubic Spline Filter 340 Reaction direction Increasing Reagent#1 250 µl Reagent#2 50 µl Delay time (Sec) 0 Incubation time (Sec) 120/300 Reading time (Sec) 10 Unit Serum mg/l Unit Urine Number of needle washes 1/2 Number of cuvette washes 1 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 1300 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name CRP Sample µl 15 Pre-Dilution 1.00

Dilution


Normal Range

Man 0 /5.0 Woman 0 /5.0 Child 0 /5.0

Urine

Name CRP Sample µl 3 Pre-Dilution 1.00

Dilution

Factor 1.00 Test Limit (Conc) 0.0 Max ABS Delta (mABS) 2000 Re-run hyperactive Inactive Re-run pathological Inactive

Normal Range

Man Woman Child


CRP FS

Order information

Cat. No. 1 7002 .. .. …

Notes

1. Please refer to the package insert for CRP FS for detailed

information about the test on the following:






3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters

high sensitive application Test CRP U

Test methodology Turbidimetric Method Fixed Time Kind of process Cubic Spline Filter 510 / -.- Reaction direction Increasing Reagent#1 150 µl Reagent#2 150 µl

Sample Starter active Incubation time (Sec) 5 Delay time (Sec) 0/0 Reading time (Sec) 240 Unit Serum mg/l Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 2000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name CRP U Sample µl 15 Pre-Dilution 1.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


CRP U-HS High sensitive (hs) application

Order information

Cat. No. 1 7045 .. .. …

Notes

1. Please refer to the package insert for CRP U-hs FS for

detailed information about the test on the following:




2. The stability of the reagent on board the analyser is at

least one month provided that contamination and evaporation are avoided.

3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Universal application Test CRP U



Serum


Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


CRP U-HS Universal (U) application

Order information

Cat. No. 1 7045 .. .. …

Notes








3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Test Ferritin

SAMPLE STARTER


Sample Starter active Delay time (Sec) 5 Incubation time (Sec) 0/0 Reading time (Sec) 240 Unit Serum µg/l Unit Urine Number of needle washes 2/1 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 2500 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name Ferritin Sample µl 15 Pre-Dilution 1.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


FERRITIN FS

Order information

Cat. No. 1 7059 .. .. …

Notes

1. Please refer to the package insert for Ferritin FS for







3. Manufactured by





January 2009/2

TARGA BT 3000 plus

Analytical parameters Test HbA1c

Test methodology Turbidimetric Method Absolute Endpoint Kind of process Cubic Spline Filter 630 / -.- Reaction direction Increasing Reagent#1 200 µl Reagent#2 100 µl Sample Starter Inactive Delay time (Sec) 0 Incubation time (Sec) 300/300 Reading time (Sec) 10 Unit Serum # Unit Urine Number of needle washes 2/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every day Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name HbA1c Sample µl 4 Pre-Dilution 1.00

Dilution

Factor 1.00 Test Limit (Conc) # Max ABS Delta (mABS) 3000 Re-run hyperactive Inactive Re-run pathological Inactive

Normal Range


Urine


Dilution


Normal Range

Man Woman Child


ONE HbA1c FS

Order information

Cat. No. 1 3329 .. .. …

Notes

1. Please refer to the package insert for oneHbA1c FS for







3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Test IgA

Test methodology Turbidimetric Method Sample Blank A Kind of process Multi Point Filter 578 / -.- Reaction direction Increasing Reagent#1 312 µl Reagent#2 62 µl Delay time (Sec) 0 Incubation time (Sec) 240/180 Reading time (Sec) 10 Unit Serum mg/dl Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 2000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name IgA Sample µl 5 Pre-Dilution 2.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


IMMUNOGLOBULIN A FS

Order information

Cat. No. 1 7202 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin A FS







3. Manufactured by





January 2010/1

TARGA BT 3000 plus

Analytical parameters Test Ferritin

SAMPLE STARTER


Sample Starter active Delay time (Sec) 5 Incubation time (Sec) 0/0 Reading time (Sec) 240 Unit Serum IU/ml Unit Urine Number of needle washes 2/1 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 2500 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name IgE Sample µl 5 Pre-Dilution 1.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


IMMUNOGLOBULIN E FS

Order information

Cat. No. 1 7239 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin E FS







3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Test IgG


Serum

Name IgG Sample µl 6 Pre-Dilution 3.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


IMMUNOGLOBULIN G FS

Order information

Cat. No. 1 7212 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin G FS







3. Manufactured by





April 2006/2

TARGA BT 3000 plus

Analytical parameters Test IgM


Serum

Name IgM Sample µl 5 Pre-Dilution 2.00

Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


IMMUNOGLOBULIN M FS

Order information

Cat. No. 1 7222 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin M FS







3. Manufactured by





May 2004/2

TARGA 3000

Analytical parameters Test Magnesium

Test methodology Xylidyl Blue Method End Point Kind of process Linear Filter 546 Reaction direction Increasing Reagent#1 300 µl Delay time (Sec) 0 Incubation time (Sec) 300 Reading time (Sec) 30 Unit Serum mg/dl Unit Urine mg/24hrs Number of needle washes 2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name Magnesium Sample µl 3 Pre-Dilution 1.00

Dilution


Normal Range

Man 1.8/2.6 Woman 1.9/2.5 Child 1.5/2.3

Urine

Name Magnesium Urine Sample µl 3 Pre-Dilution 5.00

Dilution


Normal Range

Man 73/122 Woman 73/122 Child 73/122


MAGNESIUM XL FS

Order information

Cat. No. 1 4610 .. .. …

Notes

1. Please refer to the package insert for Magnesium XL FS for







3. Manufactured by





March 2007/3

TARGA 3000

Analytical parameters Test RF

Test methodology Turbidimetric Method Sample Blank (A) Kind of process Cubic Spline Filter 340 Reaction direction Increasing Reagent#1 350 µl Reagent#2 70 µl Sample Starter Inactive Delay time (Sec) 0 Incubation time (Sec) 300/300 Reading time (Sec) 300 Unit Serum U/ml Unit Urine Number of needle washes 1/2 Number of cuvette washes 2 Dynamic Blank Inactive Reagent Blank Every run Reagent Limit (mABS) 3000 Curve Acceptance (%) 100 Instrumental Factor 1.000 Shift 0.000

Serum

Name RF Sample µl 21 Pre-Dilution 1.00

Dilution


Normal Range


Urine

Name RF Sample µl 3 Pre-Dilution 1.00

Dilution


Normal Range

Man Woman Child


RHEUMATOID FACTOR FS

Order information

Cat. No. 1 7022 .. .. …

Notes

1. Please refer to the package insert for Rheumatoid Factor

FS for detailed information about the test on the following:






3. Manufactured by





ALBUMIN FS Order information Cat. No. Kit size 10 022 021 R1 5 x 25 ml + 1 x 3 ml standard 10 022 022 R1 6 x 100 ml + 2 x 3 ml standard 10 022 023 R1 1 x 1000 ml 10 020 030 6 x 3 ml standard

Method Colorimetric test, “Bromcresol green“

Serum albumin in the presence of Bromcresol green at a slightly acid pH produces a color change of the indicator from yellow-green to green-blue.

Reagent preparation and stability

The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability in serum: 1 month at 2 – 8 °C 1 week at 15 – 25 °C

Components and concentration in the test Citrate buffer pH 4.2 30 mmol/l Bromcresol Green 0.26 mmol/l Standard: 5 g/dl

Normal range (see reference 3)

Adults 3.5 - 5.0 g/dl

References

1. Doumas, B. T., Watson, W. A., Biggs, H. G., Clin. Chim. Acta., 31, (1971), 87 - 96

2. Webster, D., Clin. Chim. Acta, 53, (1974), 109 – 115 3. Tietz, N. W.: Textbook of Clinical Chemistry, 2

nd edition,

W. B. Saunders Company, Philadelphia 1994, 703 * fluid stable

Targa BT 3000


Test Typ End Point Single Serum Starter (Inactive) Filters (A/B) 578/700 Units g/l Test Method With Factor Test Methodology BCG Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 180 Reading Time (Sec) 10 Test Limit (Conc) 60.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300

Reaction Direction Increasing Reagent Dilution 1:1 Initial ABS (mABS) 0.000 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name ALBUMIN Sample Volume (l) 3

Dilution Ratio 1:2 Min. Max. M. 35/55 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000

Urine Parameters Tests Name Urine Volume (l) 1

Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution (Inactive) Multi Factor 1.00

13.02.11

ALKALINE PHOSPHATASE DGKC FS*

Order information Cat. No. Kit size 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Kinetic colorimetric test, optimized Standard Method according to DGKC (German Society of Clinical Chemistry).

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10%.

Components and concentration in the test R1: Diethanolamine pH 9.8 1.0 mol/l Magnesium Chloride 0.5 mmol/l R2: p-Nitrophenylphosphate 10 mmol/l

Notes 1. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.

2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!


37 °C Women 64 – 306 U/l Men 80 – 306 U/l

References

1. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie, Z. Klin. Chem. u. Klin. Biochem., 8, (1970), 658

2. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie, Z. Klin. Chem. u. Klin. Biochem., 10, (1972), 182

3. Weisshaar, D., Gossrau, E., Faderl, B., Med. Welt, 26, (1975), 387

4. Schlebusch, H., Rick, W., Lang, H., Knedel, M., Dtsch. Med. Wschr., 99, (1974), 765 - 766

* fluid stable

Targa BT 3000


Test Typ Kinetic with Starter

Serum Starter (Active) Filters (A/B) 405/700 Units UI/L Test Method with Factor Test Methodology IFCC Number of washes I/I Delay Time (Sec) 90 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 800 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 1200 Curve Acceptance 100% Automatic profile (In Active) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name AP Sample Volume (l) 3

Dilution Ratio I:I Min. Max. M. 64/306 Min. Max. F. 0/0 Min. Max. B. 0/0

Urine Parameters Tests Name Urine Volume (l) I

Min. Max. M. 0/0 Min. Max. F. 0/0 Min. Max. B. 0/0 Auto Dilution (Inactive) Multi Factor 1.00

15.10.97

ALKALINE PHOSPHATASE IFCC FS*


Method Kinetic, colorimetric test according to IFCC (International Federation of Clinical Chemistry)

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.


Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10 %.

Components and concentration in the test R1: 2-Amino-2-methyl-1-propanol pH 10.4 0.35 mol/l Magnesium Sulphate 2.0 mmol/l Zinc Sulphate 1.0 mmol/l HEDTA 2.0 mmol/l R2: p-Nitrophenylphosphate 16.0 mmol/l



2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!


37 °C Men (20 – 50 years) 53 – 128 U/l Men (> 60 years) 56 – 119 U/l Women (20 – 50 years) 42 – 98 U/l Women (> 60 years) 53 – 141 U/l

References

1. Tietz, N. W., Rinker, A. D., Shaw, L. M., J. Clin. Chem. Clin. Biochem., 21, (1983), 731 – 748

2. Tietz, N. W., Textbook of Clinical Chemistry, 2nd

edition, W. B. Saunders Company, Philadelphia 1994, 2202

* fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405/700 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 90 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 2000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 800 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution 1:1 Initial ABS (mABS) 1200 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name AP Sample Volume (l) 3




Calculation Factor 5447

13.02.11

-AMYLASE CC* FS** Substrate EPS-G7 Order information Cat. No. Kit size 10 050 021 R1 5 x 20 ml + R2 1 x 25 ml 10 050 022 R1 5 x 80 ml + R2 1 x 100 ml 10 050 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Enzymatic color test with complete conversion of all PNP- Oligomaltosides produced by Amylase activity. The test results represent Total Amylase activity (all isoenzymes).

Substrate: 4,6-Ethyliden-(G7)-p-Nitrophenyl (G1)-- D-Maltoheptaoside (EPS-G7)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Stability: serum / plasma: min. 1 week at 2 – 25 °C urine: 2 days at 15 – 25 °C 10 days at 2 - 8 °C

Components and concentration in the test R1: GOOD’s buffer pH 7.1 100 mmol/l NaCl 50 mmol/l MgCl2 10 mmol/l Alpha-Glucosidase > 2 KU/l R2: GOOD’s buffer pH 7.1 100 mmol/l EPS-G7 1.6 mmol/l

Notes 1. For urine as sample material the sample volumes should be

divided in half. 2. Hemoglobin interferes.

3. Saliva and skin do contain -Amylase. Therefore never pipette by mouth and avoid skin contact with the reagents.

4. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

5. Conversion factor refers to previous PNP- G7 methods which utilised factors in order to correlate and keep the same normal range.


without conversion factor 37 °C

Serum / plasma up to 100 U/l Random urine up to 450 U/l 24 h urine up to 410 U/24 h with conversion factor 37 °C

Serum / plasma up to 220 U/l Random urine up to 1000 U/l 24 h urine up to 900 U/24 h

References

1. Hohenwallner, W., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 97 – 101

2. Kruse-Jarres, J. D., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 103

* complete color ** fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 405/700 Units UI/l Test Method With Factor Test Methodology EPS G7 Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 2000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 200 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name -Amylase Sample Volume (l) 6

Dilution Ratio 1:1 Min. Max. M. 0.000/220 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000 / 0.000



Calculation Factor with Conversion 11077 Calculation Factor without Conversion 5151

13.02.11

APOLIPOPROTEIN A1 FS* Order information Cat. No. Kit size 10 710 021 R1 5 x 25 ml + R2 1 x 25 ml 1 7100 99 10 041 1 x 1 ml Calibrator Level 1 1 x 1 ml Calibrator Level 2 1 x 1 ml Calibrator Level 3

Method Immunological, turbidimetric test, measuring range 25 – 250 mg/dl;

Endpoint determination of the concentration of Apolipoprotein A1 through photometric measurement of antigen-antibody-reaction.

Reagent preparation and stability The reagents and calibrators are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability: 5 days at 15 - 25 °C 2 weeks at 2 - 8 °C 3 months at - 20 °C (not in case of repeated deep freezing)

Calibration With 3 calibrators via a suitable curve adjustment, e.g. logit/log. Stability of calibration: 4 weeks

We recommend the use of our calibrator set as this set covers optimally the measuring range of the test kit.

Prozone limit up to at least 500 mg/dl

Components and concentration in the test R1: Buffer TRIS pH 7.5 100 mmol/l PEG, detergents, stabilizers R2: Antiserum TRIS pH 7.5 100 mmol/l Anti-human Apolipoprotein A1 Antibody (goat) with stabilizers Calibrators:

stabilized human sera, concentrations are indicated on the label


Do not swallow. Avoid contact with skin and mucous membranes.

2. No cross reactions with Apo A2 and Apo B were seen under test conditions.

3. The calibrators were only produced with human sera from donors, where no HIV-antibodies and no HbsAg were detected by FDA approved tests. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.


Men: 104 – 204 mg/dl Women: 111 – 214 mg/dl

References

1. Marcovina, S. M., Albers., J. J., Dati, F., Ledue, T. B., Ritchie, R. F., Clin. Chem., 37, (1991), 1676 – 1682

2. Steinmetz, J., Tarallo, P., Fournier, B., Caces, E., Siest, G., Eur. J. Clin. Chem. Clin. Biochem., 33, (1995), 337 - 342

fluid stable

Targa BT 3000


Test Typ End Point Double

Serum Starter In Active Filters (A/B) 578 Units mg/L Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300/10 Reading Time (Sec) 300 Test Limit (Conc) 250 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 250/50

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M Pathological Repetition

Serum Parameters Tests Name Apo AI Sample Volume (l) 2




13.02.11

1. Informações para compra Artigo Apresentação 1 0950 99 10 021 R1 5 x 25 ml + 1 x 3 ml padrão

2. Notas 1. Para informações detalhadas do kit de Bicarbonato FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Performance Características com relação a - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.

Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA

CGC: 02220795/0001-79

Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ

SVS: 10350840131

SAC (21) 3907-2534 - [email protected]

Targa BT 3000


Test Typ Cinetica com start

Serum Starter (Active) Filters (A/B) 405/510 Units mmo/l Test Method With Factor Test Methodology Bic Number of washes 1/1 Delay Time (Sec) 600 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 2000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 800 Reagents A/B (l) 350/

Reaction Direction decreasing Reagent Dilution 1:1 Initial ABS (mABS) 1200 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name Bic Sample Volume (l) 4




13.02.11

mailto:[email protected]

BILIRUBIN AUTO DIRECT FS*


Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Direct Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Test as soon as possible.

Components and concentration in the test R1: EDTA-Na2 0.07 mmol/l NaCl 6.6 g/l Sulfamic Acid 70 mmol/l R2: 2,4-Dichlorophenyl Diazoniumsalt 0.09 mmol/l HCl 130 mmol/l EDTA-Na2 0.02 mmol/l

Notes Hemoglobin interferes.


A normal range does not exist, false values up to 0.3 mg/dl (5 µmol/l) can occur.

References

1. Rand, R. N., di Pasqua, A., Clin. Chem., 8, (1962), 570 2. Henry, J., Cannon, D. C., Winkelmann, J. V.: Clinical

Chemistry, Principles and Technics, Harper & Row Publishers Inc., Hagerstown Maryland 1974, 1042

3. Thomas, L.: Labor und Diagnose, 4th edition, Die Medizinische

Verlagsgesellschaft, Marburg 1992, 235 * fluid stable

Targa BT 3000


Test Typ Endpoint with Starter

Serum Starter (Inactive) Filters (A/B) 546/700 Units mg/dl Test Method With Factor Test Methodology DCA Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 8.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name DIREKT

BILIRUBIN Sample Volume (l) 25

Dilution Ratio 1:2 Min. Max. M. 0.000/0.300 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000



15.10.97

BILIRUBIN AUTO TOTAL FS* Order information Cat. No. Kit size 10 081 021 R1 5 x 20 ml + R2 1 x 25 ml 10 081 022 R1 5 x 80 ml + R2 1 x 100 ml 10 081 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Total Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables a safe determination of the Total Bilirubin.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Stability: 1 day at 15 – 25 °C 4 days at 2 – 8 °C up to 3 months at - 20 °C (not in case of repeated deep freezing)

Components and concentration in the test R1: TRIS pH 8.2 8 mmol/l NaCl 7 g/l Detergents R2: 2,4-Dichlorophenyl Diazoniumsalt 1 mmol/l HCl 30 mmol/l Detergents

Notes Ascorbic acid and Hemoglobin interfere.

Normal range (see reference 2,3)

Newborn 0 - 24 h: up to 5 mg/dl ( 86 µmol/l) 24 - 48 h: up to 9 mg/dl ( 155 µmol/l) 3 – 5 days: up to 12 mg/dl ( 205 µmol/l) after 4 weeks: up to 1.5 mg/dl ( 26 µmol/l) Adults: up to 1.1 mg/dl (18.8 µmol/l)

References

1. Rand, R. N., di Pasqua, A., Clin Chem., 8, (1962), 570 2. Weigl, E., Bach, H., Krieg, D., Med. Klin., 70, (1975), 664 – 669 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 246 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 546/700 Units mg/dl Test Method With Factor Test Methodology DCA Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 30.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name TOTAL

BILIRUBIN

Sample Volume (l) 5




15.10.97

CALCIUM FS*

Order information Cat. No. Kit size 10 110 021 R1 5 x 25 ml + 1 x 3 ml standard 10 110 022 R1 6 x 100 ml + 2 x 3 ml standard 10 110 023 R1 1 x 1000 ml 10 110 030 6 x 3 ml standard

Method Colorimetric test, “Arsenazo III “

Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the Calcium concentration.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 15 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum; Avoid hemolysis!

Components and concentration in the test Imidazol pH 6.5 100 mmol/l Arsenazo III 120 µmol/l Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As Calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, sometimes prevent the formation of the colored complex.

3. The blank absorbance must be < 0.250 at 650 nm.


Serum 8.1 - 10.4 mg/dl (2.02 - 2.60 mmol/l)

References

1. Smith, H. G. Jr., Bauer, P. J., Biochemistry, 18, (1979), 5067 – 5073

2. Caldwell, P. C., in Cuthbert, A. W.: Calcium and Cellular Function, Macmillan, London 1970, 10 – 16

3. Sandell, E. B., Onishi, H.: Photometric determination of traces of metals, 4

th edition, John Wiley & Sons, New York 1978, 459

4. Barnett, R. N., Skodon, S. B., Goldberg, M. H., Amer. J. Clin. Path., 59, (1973), 863

* fluid stable

Targa BT 3000


Test Typ End Point Single

Serum Starter (Inactive) Filters (A/B) 630/700 Units mg/dl Test Method With Factor Test Methodology ARSENAZO Number of washes 2 Delay Time (Sec) 0 Inc. Time (Sec) 240 Reading Time (Sec) 10 Test Limit (Conc) 30 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name CALCIUM Sample Volume (l) 3



Min. Max. M. 50.0/400 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 1:5 Multi Factor 1.00

15.10.97

CALCIUM AS FS*

Order information Cat. No. Kit size 1 1130 99 10 021 R 5 x 25 ml + 1 x 3 ml Standard 1 1130 99 10 026 R 6 x 100 ml 1 1130 99 10 023 R 1 x 1000 ml 1 1130 99 10 030 6 x 3 ml Standard

Method Photometric test using arsenazo III

Principle Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the calcium concentration. Interference by magnesium is eliminated by addition of 8-hydroyquinoline-5-sulfonic acid.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents!.

Specimen Serum or heparin plasma. For urine add 10 ml concentrated HCl to the 24 h urine and heat the specimen to dissolve calcium oxalate.

Stability in serum/plasma:

7 days at 20 – 25°C 3 weeks at 2 – 8°C 8 months at -20°C Stability in urine:

2 days at 20 – 25°C 4 days at 2 – 8°C 3 weeks at -20°C

Components and Concentration in the Test Reagent Reagent pH 7.50 Phosphate buffer 50 mmol/l 8-Hydoxyquinoline-5-sulfonic acid 5 mmol/l Arsenazo III 120 µmol/l Detergents

Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, can prevent the formation of the colored complex.

3. For detailed product information see detailed package insert.

Reference range

Serum/plasma 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l) Urine <250 mg/24h (6.24 mmol/24h)

<300 mg/24h (7.49 mmol/24h)

Performance Characteristics Measuring Range The test has been developed to determine calcium concentrations within a measuring range from 0.04 – 25 mg/dl (0.01 – 6.25 mmol/l). When values exceed this range the samples should be diluted 1+1 with NaCl solution ( 9g/l) and the result multiplied by 2.

Sensitivity / Limit of detection The lower limit of detection is 0.04 mg/dl (0.01 mmol/l) . * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 630/700 Units mg/dl Test Method With Factor Test Methodology ARSENAZO Number of washes 2 Delay Time (Sec) 0 Inc. Time (Sec) 240 Reading Time (Sec) 10 Test Limit (Conc) 30 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name CALCIUM Sample Volume (l) 3



Min. Max. M. 50.0/400 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 1:5 Multi Factor 1.00

15.10.97

January 2008/1

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405 Units U/l Test Method With Factor Test Methodology BTC Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/120 Reading Time (Sec) 120 Test Limit (Conc) 20000 Reaction Limit (mABS) 100 Max ABS Delta (mABS) 900 Reagent mAbs Limit (mABS) 1000 Reagents A/B (l) 240/60

Reaction Direction Decreasing Reagent Dilution 1:1 Initial ABS (mABS) 1000 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name CHE Sample Volume (l) 5

Dilution Ratio 1:4 Min. Max. M. 4620/11500 Min. Max. F. 3930/10800 Min. Max. B. 0.000 / 0.000




**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

CHOLINESTERASE FS

Order information

Cat. No. 1 1401 .. .. …

Notes

1. Please refer to the package insert for Cholinesterase FS for





2. The stability of the reagent on board the analyser is 8

weeks provided that contamination and evaporation are avoided.

3. Manufactured by


CHLORIDE FS*


Method Colorimetric test, ”Thiocyanate”

Chloride is releasing equivalent quantities of Thiocyanate from Mercury (II) Thiocyanate. Together with Iron ions Thiocyanate forms a red colored complex. The intensity of the color is proportional to the Chloride concentration.


Specimen Serum, plasma. Avoid hemolysis!

Components and concentration in the test Mercury (II) Thiocyanate 2 mmol/l Mercury (II) Chloride 0.8 mmol/l Ferric (III) Nitrate 20 mmol/l Nitric acid 28 mmol/l Standard: 100 mEq/l (mmol/l)

Notes The reagent contains Mercury (II) Thiocyanate and Mercury (II) Chloride. Do not swallow! Avoid contact with skin and mucous membranes.


Adults: 98 - 110 mEq/l (98 - 110 mmol/l) Children: 95 - 112 mEq/l (95 - 112 mmol/l)

References

1. Schoenfeld, R. G., Lewellen, C. J., Clin. Chem., 10, (1964), 533 2. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20,

(1982), 235 - 242 * fluid stable

Targa BT 3000


Test Typ Endpoint Single

Serum Starter (Inactive) Filters (A/B) 480/700 Units mmol/L Test Method with Factor Test Methodology Thio Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 130 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 1000 Reagents A/B (l) 300

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile Inactive Rerun Test Rgt Blk H:M 00:00 Pathological Repetition Inactive

Serum Parameters Tests Name CHLORIDE Sample Volume (l) 3

Dilution Ratio I:I Min. Max. M. 98/107 Min. Max. F. 0/0 Min. Max. B. 0/0


Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution 0:2 Multi Factor 1.00

15.10.97

CHOLESTEROL FS*


Method Enzymatic colorimetric test, “CHOD-PAP“

Determination of Cholesterol after enzymatic hydrolysis and oxidation. The colorimetric indicator is Chinonimine which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 - 8 °C. The reagent must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, heparinized or EDTA plasma; Avoid hemolysis!

Components and concentration in the test GOOD's buffer pH 6.7 50 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.3 mmol/l Cholesterol Esterase > 200 U/l Cholesterol Oxidase > 50 U/l Peroxidase > 3 KU/l Standard: 200 mg/dl (5.2 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation (see reference 4)

Suspect: over 220 mg/dl (5.7 mmol/l) Elevated: over 260 mg/dl (6.7 mmol/l) As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood of about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References

1. Richmond, W., Clin. Chem., 19, (1973), 1350 - 1356 2. Roeschlau, P., Bernt, E., Gruber, W., Z. Klin. Chem. Klin.

Biochem, 12, (1974), 403 - 407 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Schettler, G., Nüssel, E., Arbeitsmed. Sozialmed.

Präventivmed., 10, (1975), 25 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 750 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name CHOLESTERO

L Sample Volume (l) 3




15.10.97

CK-MB FS*


Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340/700 Units UI/L Test Method with Factor Test Methodology UV Number of washes I Delay Time (Sec) 300 Inc. Time (Sec) 30 Reading Time (Sec) 240 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 500 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name CK-MB Sample Volume (l) 12

Dilution Ratio 1:10 Min. Max. M. 0/24 Min. Max. F. 0/0 Min. Max. B. 0/0



13.02.11

CK-NAC FS*


Method Optimized UV test according to the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry).


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability: 1 week at 2 – 8 °C 1 day at 15 – 25 °C

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l

Notes 1. Hemoglobin up to 200 mg/dl does not interfere. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Women < 165 U/l Men < 190 U/l Babies (2 - 12 months) < 325 U/l Children (after 12 months) < 225 U/l

References 1. Recommendations of the German Society of Clinical Chemistry,

J. Clin. Chem. Clin. Biochem., 15, (1977), 255 - 260

2. The Committee on Enzymes of the Scandinavian Society for Clinical Chemistry and Clinical Physiology, Scand. J. Clin. Lab. Invest., 36, (1976), 711

3. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20, (1982), 235 – 242

4. Chemnitz, G., Schmidt, E., Koller, P. U., Busch, E. W., Dtsch. Med. Wschr., 104, (1979), 257

* fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340/700 Units UI/l Test Method With Factor Test Methodology U.V. Number of washes 1/1 Delay Time (Sec) 180 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name CREATINKINAS

E

Sample Volume (l) 10

Dilution Ratio 1:4 Min. Max. M. 0.00/190 Min. Max. F. 0.00/165 Min. Max. B. 0.000 / 0.000



CALCULATION FACTOR 4920

15.10.97

CREATININE FS*

Order information Cat. No. Kit size 10 171 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 10 171 022 R1 5 x 80 ml + R2 1 x 100 ml + 2 x 3 ml std. 10 171 023 R1 1 x 800 ml + R2 1 x 200 ml 10 170 030 6 x 3 ml standard

Method Kinetic test without deproteinisation, “Jaffé“

Creatinine in an alkaline Picrate solution forms a colored orange-red complex. The delta absorbance at fixed times during conversion is proportional to the concentration of Creatinine in the sample.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C.

Specimen

Serum, heparinized plasma, urine. Dilute urine 1 + 49 with dist. water For serum / plasma: Avoid hemolysis! Stability in serum / plasma: 24 hours at 2 – 8 °C

Components and concentration in the test R1: Sodium Hydroxide 0.16 mol/l R2: Pikric acid 4.0 mmol/l Standard: 2 mg/dl (177 µmol/l)

Notes

1. Bilirubin interferes. 2. Reagent 1 contains Sodium Hydroxide. Keep out of the reach

of children. Wear suitable gloves and eye/face protection. In case of contact with eyes rinse immediately with plenty of water and seek medical advice. Remove contaminated clothing immediately.

3. Reagent 2 contains Picric Acid. Toxic by inhalation, in contact with skin and when swallowed. Wear suitable gloves and eye/face protection. After contact with skin, wash immediately with Polyethylenglycol 400 (DAB 8) or plenty of water. If sickness occurs seek medical advice.


Serum: Men 0.6 - 1.1 mg/dl (53 – 97 µmol/l) Women 0.5 - 0.9 mg/dl (44 – 80 µmol/l) Urine: 1000 - 1500 mg/24 h

Creatinine clearance (see reference 4)

Men: 98 – 156 ml/min Women: 95 – 160 ml/min

References

1. Hare, R. S., P. S. E. B. M., 74, (1950), 148 2. Kostir., J. V., Sonka, J., Biochim. Biophys. Acta, 8, (1952), 86 3. Schirmeister, J., Willmann, H., Kiefer, H., Dtsch. Med. Wschr.,

89, (1964), 1018 4. Schirmeister, J., Willmann, H., Kiefer, H., Hallauer, W.,

Dtsch. Med. Wschr., 89, (1964), 1640 5. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable

Targa BT 3000


Test Typ Fixed Time with Starter

Serum Starter (Active) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology Jaffe Number of washes 1/2 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 15.0 Reactio Limit (mABS) 1500 Max ABS Delta (mABS) 150 Reagent mAbs Limit (mABS) 600 Reagents A/B (l) 240/60


Serum Parameters Tests Name Creatinine Sample Volume (l) 18



Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 1:40 Multi Factor 1.00

15.10.97

April 2006/1

TARGA BT 3000 plus

Analytical parameters

high sensitive application Test CRP U



Serum


Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


CRP U-HS High sensitive (hs) application

Order information

Cat. No. 1 7045 .. .. …

Notes








3. Manufactured by


April 2006/1

TARGA BT 3000 plus

Analytical parameters Universal application Test CRP U



Serum


Dilution


Normal Range


Urine


Dilution


Normal Range

Man Woman Child


CRP U-HS Universal (U) application

Order information

Cat. No. 1 7045 .. .. …

Notes








3. Manufactured by


Targa BT 3000


Test Type End Point Double

Serum Starter In Active Filters (A/B) 578/700 Units µg/l Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 30 Inc. Time (Sec) 100/100 Reading Time (Sec) 100 Test Limit (Conc) 1000 Reaction Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 200/100


Serum Parameters Tests Name Ferr Sample Volume (l) 20




FERRITIN FS Order information Cat. No. Kit size 1 7059 99 10 731 R1 3 x 20 ml + R2 3 x 20 ml 1 7059 99 10 735 R1 1 x 20 ml + R2 1 x 10 ml 1 7050 99 10 058 4 x 1 ml TruCal Ferritin: Calibrator set with 4 different levels

Notes 1. Please refer to the package insert for Ferritin FS for detailed

information about the test on the following Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided. 3. Manufactured by

DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

FERRITIN FS*

Order information Cat. No. Kit size 1 7059 99 10 016 R1 2x 20 ml + R2 1 x 20ml

1 7050 99 10 058 1 x 1 ml Calibrator level 1 1 x 1 ml Calibrator level 2 1 x 1 ml Calibrator level 3 1 x 1 ml Calibrator level 4

Method Immunological particle enhanced turbidimetric test

Endpoint determination of the concentration of Ferritin through photometric measurement of antigen-antibody-reaction. Calculation: Multi-point calibration

Reagent preparation and stability The reagents and calibrators are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.The latex reagent(R2) must be homogenised by mixing before use. Do not freeze the reagents!

Specimen Fresh serum. Stability: 7 days at 2 - 8 °C 4 weeks at - 20 °C

(Do not refreeze) Discard haemolysed and contaminated sera.

Prozone limit No prozone effect observed up to an Ferritin concentration of 1400 µg/l. The measuring range of the kit is up to 1000 µg/l and when values exceed this they must be diluted 1 + 1 with 0.9% NaCl solution. Multiply the result by 2.

Components and concentration in the test R1 Glycine 155 mmol/l NaCl 91 mmol/l Bovine serum albumin R2: Glycine buffer 155 mmol/l NaCl 91 mmol/l Latex particles coated with anti ferritin antibody (Rabbit) Calibrators: Stabilised human plasma

Activity stated on the label

Notes 1. The reagents and calibrators contain Sodium Azide (0.095 %)

as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

2. The calibrators were only produced with human plasma which were found to be nonreactive for HBsAg and anti-HIV 1+2 when tested by FDA accepted methods. As no test can offer complete assurance that products derived from human blood will not transmit infectious agents, it is recommended that the calibrators should be handled with the same precautions used for patient specimens.

Normal range Adults 30 – 300 µg/l

<50y 10 – 160 µg/l

>50y Increase to male values

Children 15 – 120 µg/l

References 1. Cook, J.D., Lipschitz, D:A., Laughton, M.B.B., Miles, E.M., and

Finch, C.A.: Serum ferritin as a measure of iron stores in normal subjects. Am. J. Clin. Nutr. 27:680-, 1974

2. Addison, G. M., Beamish, M.R., Hales, C.N., Hodgkins, M., Jacobs, A. and Llesellin, P.: An immunoradiometric assay for ferritin in the serum of normal subjects and patients with iron deficiency and iron overload. J. Clin. Path. 25:326-, 1973

3. Marcus, D. M. and Zinberg, N.: Isolation of ferritin from human mammary and pancreatic carcinomas by means of antibody immunoadsorbents. Arch. Biochem. Biophys. 162:493-, 1974

4. Wick M. Pinggera W. and Lehmann P. In: ferritin im eisenstoffwechsel und diagnostik der anämien, 2

nd edition,

springer-verlag vienna/new york, 1994; 47 * fluid stable

Targa BT 3000


Test Type End Point Double

Serum Starter In Active Filters (A/B) 578 Units µg/l Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 30 Inc. Time (Sec) 100/100 Reading Time (Sec) 100 Test Limit (Conc) 1000 Reaction Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 200/100


Serum Parameters Tests Name Ferr Sample Volume (l) 20




13.02.11

FOSFATO UV FS*

Order information

Cat. No. Kit size 1 5211 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + padrão 1 x 3 ml

Notas: 1. Para informações detalhadas do kit de Fosfato UV FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Performance Características com relação a: - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.

Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA

CGC: 02220795/0001-79

Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: SAC (21) 3907-2534 - [email protected]

* fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 340/700 Units mg/dl Test Method With Factor Test Methodology UV Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 30.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 300


Serum Parameters Tests Name FOSFATO Sample Volume (l) 3



Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 0 Multi Factor 1.00

15.10.97


GAMMA-GT FS*


Method Kinetic colorimetric test according to Szasz / Persijn (1974)

Gamma-GT catalyzes the transfer of Glutamic acid to acceptors like Glycylglycine in this case. This process releases 5-Amino-2-Nitrobenzoate which absorbs light at 405 nm. The increase in absorbance at this wavelength is directly related to the activity of Gamma-GT.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Reagent 2 must be protected from light.

Specimen Serum, EDTA plasma. Avoid hemolysis. Stability: at least 1 week at between – 20 °C and + 20 °C.

Components and concentration in the test R1: TRIS buffer pH 8.25 100 mmol/l Glycylglycine 100 mmol/l R2: L-Gamma-glutamyl-3-carboxy-

4-nitroanilide 4 mmol/l

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.


37 °C Men: 11 - 50 U/l Women: 7 - 32 U/l

References 1. Szasz, G., Weimann, G., Stähler, F., Wahlefeld, A.-W.,

Persijn, J.-P., Z. Klin. Chem. Klin. Biochem., 12, (1974), 228 2. Persijn, J.-P., van der Slik, W., J. Clin. Chem. Clin. Biochem.,

14, (1976), 421 – 427 3. Szasz, G., Clin. Chem., 15, (1969), 124 – 136 4. Szasz, G., in Bergmeyer, H. U.: Methoden der enzymatischen

Analyse, 3rd edition, Verlag Chemie, Weinheim / Bergstraße

1974, 759 * fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405 Units UI/l Test Method With Factor Test Methodology SZAZS Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/60 Reading Time (Sec) 60 Test Limit (Conc) 800 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 900 Reagent mAbs Limit (mABS) 1500 Reagents A/B (l) 240/60


Serum Parameters Tests Name GGT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 11.0/50.0 Min. Max. F. 7.00/32.0 Min. Max. B. 0.000 / 0.000




15.10.97

GLUCOSE FS* GOD-PAP


Method Enzymatic colorimetric test, “GOD-PAP“

Determination of Glucose after enzymatic oxidation by Glucose oxidase. The colorimetric indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Separate latest 1 h after blood collection from cellular contents. Stability after addition of a glycolytic inhibitor (NaF, KF): 7 days at 2 – 8 °C 24 h at 15 – 25 °C

Components and concentration in the test Phosphate buffer pH 7.5 250 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.5 mmol/l Glucose Oxidase > 10 KU/l Peroxidase > 1 KU/l Standard: 100 mg/dl (5.55 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Normal range (fasting) (see reference 2)

55 - 115 mg/dl (3.05 – 6.4 mmol/l)

References

1. Barham, D., Trinder, P., Analyst., 97, (1972), 142 - 145 2. Thomas, L.: Labor und Diagnose, 4

th edition, Die Medizinische


Targa BT 3000


Test Typ Endpoint Single Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 600 Reading Time (Sec) 10 Test Limit (Conc) 400 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name GLUCOSE Sample Volume (l) 3




15.10.97

GLUCOSE HEXOKINASE FS* Determination without deproteinisation

Order information Cat. No. Kit size 10 251 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 10 251 022 R1 5 x 80 ml + R2 1 x 100 ml + 2 x 3 ml std. 10 251 023 R1 1 x 800 ml + R2 1 x 200 ml 10 250 030 6 x 3 ml standard

Method Enzymatic UV test, “Hexokinase“

Hexokinase acts on Glucose to produce Glucose-6-Phosphate and ADP. G-6-PDH catalyzes the change of Glucose-6-Phosphate in presence of NAD

+ to 6-Phospho-Gluconate and NADH.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, plasma, urine. For serum / plasma: Avoid hemolysis! Separate latest 1 h after blood collection from cellular contents. Stability after addition of a glycolytic inhibitor (NaF, KF): 7 days at 2 – 8 °C 24 h at 15 – 25 °C

Components and concentration in the test R1: TRIS Buffer pH 7.8 80 mmol/l ATP 1.7 mmol/l NAD 1.7 mmol/l Mg

2+ 4 mmol/l

R2: Mg

2+ 4 mmol/l

Hexokinase > 1.5 KU/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l

Standard: 100 mg/dl (5.55 mmol/l)

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!

Normal range (fasting)(see reference 3)

Serum: 55 – 115 mg/dl (3.05 – 6.4 mmol/l) Urin: up to 15 mg/dl (0.84 mmol/l)

References 1. Schmidt, F. H., Klin. Wschr., 39, (1961), 1244 2. Hoffmeister H., Junge, B., Z. Klin. Chem. Klin. Biochem., 8,

(1970), 613 – 617 3. Thomas, L.: Labor und Diagnose, 4



Targa BT 3000


Test Typ End point double

Serum Starter InActive Filters (A/B) 340/405 Units mg/dl Test Method with Factor Test Methodology UV Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 900 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 1200 Reagents A/B (l) 240/60


Serum Parameters Tests Name GLUCOSE Sample Volume (l) 3



Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution Multi Factor 1.00

13.02.11

GOT (ASAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate

Order information Cat. No. Kit size 10 260 021 R1 5 x 20 ml + R2 1 x 25 ml 10 260 022 R1 5 x 80 ml + R2 1 x 100 ml 10 260 023 R1 1 x 800 ml + R2 1 x 200 ml For determination with Pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)


Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 – 25 °C < 10 %.

Components and concentration in the test R1: TRIS buffer pH 7.8 80 mmol/l L-Aspartate 240 mmol/l MDH > 600 U/l LDH > 600 U/l R2: 2-Oxoglutarate 12 mmol/l NADH 0.18 mmol/l Pyridoxal-5-phosphate FS

GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat. No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1.

Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. Hemoglobin interferes. 3. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 37 U/l Women up to 31 U/l

with Pyridoxal-5-phosphate activation (see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 497 – 510 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190 * fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 600 Reactio Limit (mABS) 700 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60


Serum Parameters Tests Name GOT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 0.000/37.0 Min. Max. F. 0.000/31.0 Min. Max. B. 0.000 / 0.000




15.10.97

GPT (ALAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate

Order information Cat. No. Kit size 10 270 021 R1 5 x 20 ml + R2 1 x 25 ml 10 270 022 R1 5 x 80 ml + R2 1 x 100 ml 10 270 023 R1 1 x 800 ml + R2 1 x 200 ml For determination with Pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)


Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 10 % and at 15 – 25 °C < 17 %.

Components and concentration in the test R1: TRIS buffer pH 7.5 100 mmol/l L-Alanine 500 mmol/l LDH > 1200 U/l

R2: 2-Oxoglutarate 15 mmol/l NADH 0.18 mmol/l

Pyridoxal-5-phosphate FS GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat-No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1. Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 42 U/l Women up to 32 U/l with Pyridoxal-5-phosphate activation

(see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 481 - 493 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190 * fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 600 Reactio Limit (mABS) 700 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60


Serum Parameters Tests Name GPT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 0.000/42.0 Min. Max. F. 0.000 / 32.0 Min. Max. B. 0.000 / 0.000




15.10.97

HDL-C IMMUNO FS*

Order information Cat. No. Kit size 1 3521 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml 1 3521 99 10 022 R1 5 x 80 ml + R2 1 x 100 ml 1 3521 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml 1 3520 99 10 065 3 x 3 ml calibrator

Method HDL-C Immuno is a homogeneous method without centrifugation step. Antigen – antibody complexes are formed with LDL,VLDL and Chylomicrons in a way that only HDL-C is selectively determined by an enzymatic measurement.

Reagent preparation and stability The reagents and the calibrator are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

On board stability: 4 weeks at 2 - 8 °C

Stability of calibrator after reconstitution*:

5 days 1 month

at at

2 - 8 °C - 20 °C

*The calibrator package insert has instructions on handling and reconstitution.

Specimen Serum, heparinized plasma. Avoid hemolysis!

Stability: 1 week at 2 - 8 °C 1 month at below - 20 °C 2 years at below - 70 °C

Components and concentration in the test R1: Good’s Buffer pH 7.0 30 mmol/l 4-Aminoantipyrine 0.54 mmol/l Peroxidase 1440 U/l Ascorbate Oxidase 1620 U/l Anti-human - lipoprotein antibody

R2: Good’s Buffer pH 7.0 30 mmol/l Cholesterol Esterase 800 U/l Cholesterol Oxidase 4000 U/l F-DAOS** 0.16 mmol/l Calibrator: as indicated on the label (approx. 50 mg/dl)

Notes The calibrator was only produced with human sera. The human serum used was tested and found negative for HBsAg, anti-HIV antibody and anti-HCV antibody. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.


Lipid metabolic disorder Cholesterol < 200 mg/dl (5.2 mmol/l) No Triglycerides < 200 mg/dl (2.3 mmol/l)

Cholesterol 200 - 300 mg/dl Yes, if HDL-Cholesterol (5.2 – 7.8 mmol/l) < 35 mg/dl ( 0.9 mmol/l)

Cholesterol > 300 mg/dl (7.8 mmol/l) Yes Triglycerides > 200 mg/dl (2.3 mmol/l)

As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood to about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References 1. Friedewald, W. T., et al., Clin. Chem., 18, (1972), 499 2. Study Group, European Atherosclerosis Society, European Heart

Journal, 8, (1987), 77 – 88 3. Rifal, N., Warnick, G. R., Laboratory Measurement of Lipids,

Lipoproteins and Apolipoproteins. AACC Press. Washington DC, USA 1994

4. Burtis, C. A., Ashwood, E. R., Tietz, N. W.: Textbook of Clinical Chemistry, 2nd edition, W. B. Saunders Company, Philadelphia 1994

5. Gordon, T., Castelli, W. P., Hjortland, M. C., et al., Am. J. Med. 62, (1977), 707 - 714

* fluid stable ** F-DAOS = N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy- 4-fluoroaniline, sodium salt

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units mmol//l Test Method With Factor Test Methodology imuno Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 180 Reaction Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name HDL

Sample Volume (l) 3




15.10.97

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units g/dl Test Method With Factor Test Methodology Ferene Number of washes 1/3 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 1000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 300/75


Serum Parameters Tests Name IRON Ferene Sample Volume (l) 18

Dilution Ratio 1:1 Min. Max. M. 35.0/168 Min. Max. F. 23.0/165 Min. Max. B. 0.000/0.000

Urine Parameters Tests Name URINE IRON Urine Volume (l) 0


CALIBRATOR

IRON FS Ferene Order information Cat. No. Kit size 1 1911 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1911 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 1911 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

10 190 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Iron FS Ferene for







3. Manufactured by

DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Sept 2001/1

IRON FS*

Order information Cat. No. Kit size 10 190 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 1901 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 190 023 R1 1 x 800 ml + R2 1 x 200 ml 10 190 030 6 x 3 ml standard

Method Colorimetric test, “Nitro-PAPS“ Nitro-PAPS: 2-(5-Nitro-2-pyridylazo)-5-[N-propyl-N- (3-sulfopropyl) -amino]phenol

Iron normally bound to Transferrin is released completely by Guanidium chloride and detergents and is reduced to Fe

2+. Fe

2+

forms a red colored complex. The absorbance of the color is directly proportional to the Iron concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen

Serum, heparinized plasma; Avoid hemolysis! Stability in serum: 7 days at 2 – 8 °C 4 days at 15 – 25 °C

Components and concentration in the test R1: Sodium Acetate pH 4.3 0.1 mol/l Guanidinium Chloride 4 mol/l Detergent 0.1 g/l Reducing agent R2: Sodium Acetate pH 4.3 0.1 mol/l Guanidinium Chloride 4 mol/l Detergent 0.1 g/l Nitro-PAPS 35 µmol/l Standard: 100 µg/dl (17.9 µmol/l)

Notes Use only disposal material to avoid Iron contamination. Rinse glass material with diluted HCl and copious dist. water.


Men: 59 - 158 µg/dl (10.6 - 28.3 µmol/l) Women: 37 - 145 µg/dl (6.6 - 26.0 µmol/l)

References

1. Weippl, G., Pantlitschko, M., Bauer, P., Lund, S., Blut, 27, (1973), 261 – 270

2. Makino, T., Kiyonaga, M., Kina, K., Clin. Chim. Acta, 171, (1988), 19 - 28

* fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units g/dl Test Method With Factor Test Methodology NITRO PAPS Number of washes 1/3 Delay Time (Sec) 0 Inc. Time (Sec) 240/120 Reading Time (Sec) 10 Test Limit (Conc) 1000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 300/75


Serum Parameters Tests Name IRON n-PAPS Sample Volume (l) 20

Dilution Ratio 1:1 Min. Max. M. 59.0/158 Min. Max. F. 37.0/145 Min. Max. B. 0.000/0.000

Urine Parameters Tests Name URINE IRON Urine Volume (l) 0


CALIBRATOR

15.10.97

LDH DGKC FS*


Method Optimized UV test according to DGKC (German Society of Clinical Chemistry)


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 – 25 °C < 2 %.

Components and concentration in the test

R1: Phosphate pH 7.5 50 mmol/l Pyruvate 0,6 mmol/l R2: NADH 0,18 mmol/l

Notes

1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Adults: 225 – 450 U/l

References 1. Empfehlungen der Deutschen Gesellschaft für Klinische

Chemie, Z. Klin. Chem. u. Klin. Biochem., 8, (1970), 658 2. Empfehlungen der Deutschen Gesellschaft für Klinische

Chemie, Z. Klin. Chem. u. Klin. Biochem., 10, (1972), 182 3. Elliot, B. A., Wilkinson, J. H., Clin. Sci., 24, (1963), 343 – 355 4. Weißhaar, D., Gossrau, E., Faderl, B., Med. Welt, 26,

(1975), 387 * fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology DGKC Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 1200 Reactio Limit (mABS) 100 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 1100 Reagents A/B (l) 240/60


Serum Parameters Tests Name LDH Sample Volume (l) 3

Dilution Ratio 1:4 Min. Max. M. 225/450 Min. Max. F. 225/450 Min. Max. B. 0.000 / 0.000




15.10.97

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units mg/dl Test Method With Factor Test Methodology LDL Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 400 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name LDL

Sample Volume (l) 3




13.02.11

LDL-C SELECT FS

Order information

Cat. No. Kit size

1 4121 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml

1 4121 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 4121 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

1 3520 99 10 065 3 x 3 ml Calibrator

1 4121 99 10 717 R1 5x 80 ml + R2 5 x 20 ml

Notes

1. Please refer to the package insert for LDL-C

Select FS for the detailed information about

the test on the following:

Clinical Relevance

Method and Principle

Composition and Stability of the Reagents

Specimens

Calibrators and Controls

Performance Characteristics concerning;

Measuring Range

Specificity/Interferences

Sensitivity/Limit of Detection

Precision (Reproducibility,

Repeatability)

Method Comparison

Reference Ranges

Literature

2. The stability of the reagent on board the

analyser is at least one month provided that

contamination and evaporation are avoided.

3. Manufactured by DiaSys Diagnostic Systems GmbH

& Co.KG Alte Strasse 9, 65558 Holzheim,

Germany.

LIPASE FS*

Order information

Cat. No. Kit size 10 430 021 R 5 x 25 ml + 1 x 1 ml standard

1 4300 99 10 026 R 6 x 100 ml 10 430 023 R 1 x 1000 ml 10 430 030 6 x 3 ml standard

Method Turbidimetric UV test

Lipase catalyzes the decomposition of Triolein to Monoglycerides and Oleic acid. The decrease in turbidity is measured in the UV range.

Reagent preparation and stability The reagent and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be well mixed before use.

Specimen

Serum, heparinized plasma; Avoid hemolysis! Stability: 5 days at 2 - 8 °C 24 hours at 15 - 25 °C


TRIS Buffer pH 9.2 25 mmol/l Triolein 0.31 mmol/l Calcium Chloride 0.20 mmol/l Sodium Chloride 31 mmol/l Colipase 180 KU/l Standard: Activity see label

Notes

1. The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

2. As many other clinical chemistry reagents contain Lipase, avoid carry over! Cuvettes and other glassware must be cleaned thoroughly after being used for other assays.

3. In rare cases, a patient’s serum may exhibit an absorbance increase instead of a decrease. To avoid negative values, dilute these samples 1 + 1 with 0.9 % NaCl solution and repeat the assay. Multiply the result by 2.


up to 190 U/l

References

1. Weisshaar, H. D., Sudhoff, H., Koller, P. U., Bablok., W., Dtsch. Med. Wschr., 106, (1981), 239

2. Lott, J. A., et al., Clin. Chem., 32, (1966), 1290 3. Ziegenhorn J., Neumann, K. W., Knitsch, K. W., Zwez, W.,

Clin. Chem., 25, (1979), 1067 * fluid stable

Targa BT 3000



Serum Starter Active Filters (A/B) 340/700 Units UI/L Test Method with Factor Test Methodology UV Number of washes I Delay Time (Sec) 300 Inc. Time (Sec) 0 Reading Time (Sec) 300 Test Limit (Conc) 1500 Reactio Limit (mABS) 200 Max ABS Delta (mABS) 1000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300

Reaction Direction Decreasing Reagent Dilution I:I Initial ABS (mABS) 2500 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition In Active

Serum Parameters Tests Name Lipase Sample Volume (l) 10




13.02.11

BioSys 16.03.2006

TARGA (BT Plus/3000)

PCR Ultra Sensível

1. Informações para pedido Artigo nº Apresentação 1 7045 99 10 730 R1 3 x 20ml + R2 3 x 20 ml Calibrador para faixa universal (5 níveis) 1 7040 99 10 059 5 x 1 ml TruCal PCR U-hs Calibrador para faixa ultra-sensível (5 níveis) 1 7080 99 10 059 5 x 1 ml TruCal PCR hs

2. Instrument Setting

TEST TYPE Fixed Time With Starter

SERUM STARTER (Inactive)

FILTERS (A/B) 500 / 700

UNITS mg/dL

TEST METHOD Cubic Spline

TEST METHODOLOGY Turbidimetric

NUMBER OF WASHES 3 / 2

DELAY TIME (SEC) 0

INC. REAGENT (SEC) 240 / 0

READING TIME (SEC) 260

TEST LIMIT (CONC) 20

REACTION LIMIT (mABS) 2000

MAX ABS DELTA (mABS) 2000

REAGENT mABS LIMIT 2000

REAGENTS A/B (µL) 150/150

REACTION DIRECTION Increasing

REAGENT DILUTION 1:1

INITIAL ABS (mABS) 2000

CURVE ACCEPTANCE 100%

AUTOMATIC PROFILE (Inactive)

RERUN TEST RGT. BLK H:M 12:00

DYNAMIC BLANK (Inactive)

PATHOLOGICAL REPETITION (Inactive)

SERUM PARAMETERS

TEST NAME CRP US

SAMPLE VOLUME (µL) 15

DILUTION RATIO 1:0

MIN. MAX. M. 0.00/1.00

MIN. MAX. F. 0.00/0.00

MIN. MAX. B. 0.00/0.00

3. Notas 1. Para informações detalhadas do kit de PCR U hs FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Performance Características com relação a: - Faixa de Medição

BioSys 16.03.2006

- Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.

Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA CGC: 02220795/0001-79 Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: 10350840130 SAC (21) 3907-2534 - [email protected]


BioSys 16.03.2006

TARGA (BT Plus/3000)

PCR U hs (Ultra Sensível)

1. Informações para pedido Artigo nº Apresentação 1 7045 99 10 730 R1 3 x 20ml + R2 3 x 20 ml Calibrador para faixa universal (5 níveis) 1 7040 99 10 059 5 x 1 ml TruCal PCR U-hs Calibrador para faixa ultra-sensível (5 níveis) 1 7080 99 10 059 5 x 1 ml TruCal PCR hs

2. Instrument Setting

TEST TYPE Fixed Time With Starter

SERUM STARTER (Inactive)

FILTERS (A/B) 500 / 700

UNITS mg/dL

TEST METHOD Cubic Spline

TEST METHODOLOGY Turbidimetric

NUMBER OF WASHES 3 / 2

DELAY TIME (SEC) 0

INC. REAGENT (SEC) 240 / 0

READING TIME (SEC) 260

TEST LIMIT (CONC) 20

REACTION LIMIT (mABS) 2000

MAX ABS DELTA (mABS) 2000

REAGENT mABS LIMIT 2000

REAGENTS A/B (µL) 150/150

REACTION DIRECTION Increasing

REAGENT DILUTION 1:1

INITIAL ABS (mABS) 2000

CURVE ACCEPTANCE 100%

AUTOMATIC PROFILE (Inactive)

RERUN TEST RGT. BLK H:M 12:00

DYNAMIC BLANK (Inactive)

PATHOLOGICAL REPETITION (Inactive)

SERUM PARAMETERS

TEST NAME CRP U hs

SAMPLE VOLUME (µL) 3

DILUTION RATIO 1:0

MIN. MAX. M. 0.00/1.00

MIN. MAX. F. 0.00/0.00

MIN. MAX. B. 0.00/0.00

3. Notas 1. Para informações detalhadas do kit de PCR U hs FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Performance Características com relação a: - Faixa de Medição

BioSys 16.03.2006

- Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.

Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA CGC: 02220795/0001-79 Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: 10350840130 SAC (21) 3907-2534 - [email protected]


PHOSPHORUS UV FS*

Order information

Cat. No. Kit size 10 520 021 R 5 x 25 ml + 1 x 3 ml standard 1 5200 99 10 026 R 6 x 100 ml 10 520 023 R 1 x 1000 ml 10 520 030 6 x 3 ml standard

Method Photometric UV test

Phosphorus reacts with Ammonium Molybdate and Sulphuric Acid to form an inorganic Phosphorus Molybdate complex. The complex absorption is maximal in ultraviolet light at 340 nm.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C.

Specimen Serum, heparinized plasma, urine. For serum / plasma: Avoid hemolysis! For collection of 24 h urine, please add 10 ml of 10 % HCl into the collection bottle to avoid phosphate precipitations. Dilute the specimen before determination 1 + 20 with dist. water. Multiply the result by 21.


Sulphuric acid pH 1.0 210 mmol/l Ammonium Molybdate 0.4 mmol/l Detergents Standard: 5 mg/dl (1.61 mmol/l)

Notes

The reagent contains Sulphuric Acid. Carefully rinse skin and mucous membranes with water after contact with the reagent.


Adults: 2,7 - 4,5 mg/dl 0,87 - 1,45 mmol/l Children up to 4 weeks: 4,8 - 9,6 mg/dl 1,56 - 3,10 mmol/l up to 12 months: 4,8 - 7,9 mg/dl 1,56 - 2,54 mmol/l > 12 months: 3,4 - 6,2 mg/dl 1,09 - 2,00 mmol/l 24 h urine: 0,4 - 1,3 g/24 h 13 - 42 mmol/24 h

References

1. Daly, J. A., Ertingshausen, G., Clin. Chem., 18, (1972), 263 2. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 218 3. Tietz, N. W.: Textbook of Clinical Chemistry, 2

nd edition,

W. B. Saunders Company, Philadelphia 1994, 2202 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 340/700 Units mg/dl Test Method With Factor Test Methodology UV Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 15.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 300


Serum Parameters Tests Name PHOSPHORU

S Sample Volume (l) 3



Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 0 Multi Factor 1.00

15.10.97

TOTAL PROTEIN IN URINE FS* Order information Cat. No. Kit size 1 0210 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 0210 99 10 026 R 6 x 100 ml 1 0210 99 10 023 R 1 x 1000 ml 1 0210 99 10 030 6 x 3 ml standard

Method Colorimetric test, “Pyrogallol Red“

Proteins together with Pyrogallol Red / Molybdate form a red complex. The color is directly proportional to the protein concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen Urine, cerebro-spinal fluid

Components and concentration in the test Pyrogallol Red 50 µmol/l Sodium Molybdate 40 µmol/l Detergents Standard: 0.2 g/l (200 mg/l)


Urine 40 – 80 mg/24 h Cerebro-spinal fluid (liquor) up to 500 mg/l * *This value is only to be taken as a guide line. Reference values are declared for liquor / serum quotients on the general package insert. Liquor / serum quotients for albumin:

30th week of pregnancy < 50 x 10

-3

Birth < 25 x 10-3

1 month < 15 x 10-3

6 months < 5 x 10-3

20 years < 5 x 10-3

40 years < 7 x 10-3

60 years < 8 x 10-3

These values are approximately equal to the liquor / serum quotient of Total Protein. For exact calculation refer to the following table:

Q (Albumin) Q (Total Protein) 7 x 10

-3 8 x 10

-3

10 x 10-3

11 x 10-3

20 x 10

-3 18 x 10

-3

50 x 10-3

40 x 10-3

References 1. Fujita, Y., Mori, I., Kitano, S., Bunseki Kakagu, 32, (1983), 379

– 386 2. Orsonneau, J.-L., Douet, P., Massoubre, C., Lustenberger, P.,

Bernard, S., Clin. Chem., 35, (1989), 2233 3. Watanabe, N., Kamei, S., Ohkubo, A., Yamanaka, M., Ohsawa,

S., Makino, K., Tokuda, K., Clin Chem., 32, (1986), 1551 4. Guder, W. G., Hofmann, W., Weber, M. H.: Kleinkonferenz

“Proteinurie“, DG Klinische Chemie Mitteil., 22, (1991), 78 5. Thomas, L.: Labor und Diagnose, 4


Verlagsgesellschaft, Marburg 1992, 1716

* fluid stable

Targa BT 3000


Test Typ End Point Single Serum Starter (Inactive) Filters (A/B) 578/700 Units mg/l Test Method With Factor Test Methodology PR Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 3000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name TPU Sample Volume (l) 3

Dilution Ratio 1:2 Min. Max. M. / Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000


Min. Max. M. 24 / 141 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution (Inactive) Multi Factor 1.00

TOTAL PROTEIN FS* Order information Cat. No. Kit size 10 231 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std 1 2311 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 231 023 R1 1 x 800 ml + R2 1 x 200 ml 10 230 030 6 x 3 ml standard

Method Colorimetric test, “Biuret“

Proteins together with Copper ions form a violet blue complex in alkaline solution. The absorbance of the color is directly proportional to the concentration.


Specimen

Serum or plasma. Avoid hemolysis!


R1: Sodium Hydroxide 80 mmol/l Potassium Sodium Tartrate 12.8 mmol/l R2: Sodium Hydroxide 100 mmol/l Potassium Sodium Tartrate 16 mmol/l Potassium Iodide 15 mmol/l Copper Sulphate 6 mmol/l Standard: 5 g/dl

Notes

1. Serum or plasma from patients who have received large intravenous amounts of Polydextrans yields values which are too high with the Biuret method. In such cases the protein concentration should be determined by an alternative method (e. g. Kjeldahl).

2. The reagents contain Sodium Hydroxide. Do not swallow! If the reagents come in contact with skin of mucous membranes rinse immediately with water!


Adults: 6,2 – 8,4 g/dl Children 1 day – 4 weeks: 4,52 – 6,86 g/dl 2 – 12 months: 4,57 – 7,33 g/dl > 12 months: 5,85 – 8,01 g/dl

References

1. Henry, R. J., Sobel, C., Berkmann, S., Anal. Chem., 29, (1957), 1491

2. Peters, T., Clin. Chem., 14, (1968), 1147 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 263 * fluid stable

Targa BT 3000



Serum Starter In Active Filters (A/B) 546/700 Units g/L Test Method with Factor Test Methodology Biuret Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 150 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 300 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition In Active

Serum Parameters Tests Name Total Protein Sample Volume (l) 6




13.02.11

TRIGLYCERIDES FS* Order information Cat. No. Kit size 10 571 021 R1 5 x 25 ml + 1 x 3 ml standard 10 571 022 R1 6 x 100 ml + 2 x 3 ml standard 10 571 023 R1 1 x 1000 ml 10 570 030 6 x 3 ml standard

Method Colorimetric enzymatic test, “GPO“

Determination of Triglycerides after enzymatic splitting with Lipoprotein Lipase. Indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis!


GOOD‘ s buffer pH 7.2 50 mmol/l 4-Chlorophenol 4 mmol/l

Mg2+ 15 mmol/l

ATP 2 mmol/l Glycerokinase > 0.4 KU/l Peroxidase > 2 KU/l Lipoprotein Lipase > 2 KU/l 4-Aminoantipyrine 0.5 mmol/l Glycerol-3- phosphate Oxidase > 0.5 KU/l Standard: 200 mg/dl (2.3 mmol/l)

Notes

1. To correct for free Glycerol, subtract 10 mg/dl (0.11 mmol/l) from the Triglycerides result.

2. Ascorbic acid interferes. 3. The reagent contains Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes !


Suspect over: 150 mg/dl (1.71 mmol/l) Increased over: 200 mg/dl (2.28 mmol/l)

References

1. Schettler, G., Nüssel, E., Arbeitsmedizin Sozialmedizin Präventivmedizin, 10, (1975), 25

2. Jacobs, N. J., Vandemark, P. J., Arch. Biochem. Biophys., 88, (1960), 250 – 255

3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Koditschek, L. K., Umbreit, W. W., Journ. of Bacteriol., 98,

(1969), 1063 - 1068 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 1000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name TRIGLYCERID

E Sample Volume (l) 3

Dilution Ratio 1:4 Min. Max. M. 60.0/150 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000



CALIBRATOR:

15.10.97

UREA FS*

Order information

Cat. No. Kit size 10 310 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3101 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 310 023 R1 1 x 800 ml + R2 1 x 200 ml 10 310 030 6 x 3 ml standard

Method Enzymatic UV test, “Urease - GLDH“

Urease acts on Urea to produce Ammonium and Carbonate ions. Glutamic Dehydrogenase catalyzes the oxidation of Ammonium ions with 2-Oxoglutarate and NADH under formation of Glutamate. The decrease of NADH is proportional to the Urea concentration.


Specimen

Serum, plasma (no Ammonium Heparin), fresh urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 100 with dist. water Stability in serum / plasma: 1 week at 2 – 8 °C 2 days at 15 – 25 °C

Components and concentration in the test R1: Tris buffer pH 7.8 120 mmol/l 2-Oxoglutarate 7 mmol/l ADP 0.6 mmol/l Urease > 6 KU/l GLDH > 1 KU/l R2: NADH 0.25 mmol/l Standard: 50 mg/dl (8.33 mmol/l)

Notes

1. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!

2. To convert Urea into BUN multiply by 0.47; to convert BUN into Urea multiply by 2.14.


Serum / plasma: 10 - 50 mg/dl (1.7 - 8.3 mmol/l) Urine: 20 - 35 g/24 h (333 - 583 mmol/24 h)

References

1. Talke, H., Schubert, G. E., Klin. Wschr., 43, (1965), 174 2. MacKay, E. M., MacKay, L. L., J. Clin. Invest., 4, (1927), 295 3. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable

Targa BT 3000


Test Typ Fixed Time with Starter

Serum Starter (Active) Filters (A/B) 340/700 Units mg/dl Test Method With Factor Test Methodology U.V. Number of washes 1/1 Delay Time (Sec) 30 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 300 Reactio Limit (mABS) 400 Max ABS Delta (mABS) 500 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60


Serum Parameters Tests Name UREA Sample Volume (l) 3


Urine Parameters Tests Name URINE UREA Urine Volume (l) 3


CALIBRATOR:

15.10.97

URIC ACID FS* TOOS

Order information

Cat. No. Kit size 10 300 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3001 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 300 023 R1 1 x 800 ml + R2 1 x 200 ml 10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TOOS“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and N-Ethyl- N-(2-hydroxy-3-sulfopropyl)-m-toluidin (TOOS) to a blue violet dye.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with dist. water.


R1: Phosphate buffer pH 7.0 100 mmol/l TOOS 1 mmol/l Ascorbate Oxidase > 1 KU/l R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 1 KU/l Uricase > 50 U/l Standard: 6 mg/dl (357 µmol/l)

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!


Serum: Men: 3.4 - 7.0 mg/dl 200 – 420 µmol/l Women: 2.4 - 5.7 mg/dl 140 – 340 µmol/l Urine: 250 - 750 mg/24 h 1.5 - 4.5 mmol/24 h

References

1. Barham, D., Trinder, P., Analyst, 97, (1972), 142 – 145 2. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U.,

Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384 3. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry,

Principles and Technics, 2nd

edition, Harper & Row Publishers Inc., Hagerstown Maryland 1974, 534

4. Fossati, P., Prencipe, L., Berti, G., Clin. Chem., 26, (1980), 227 – 231

* fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 546700 Units mg/dl Test Method With Factor Test Methodology TOOS Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 20 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 100 Reagents A/B (l) 240/60


Serum Parameters Tests Name URIC ACID Sample Volume (l) 6




CALIBRATOR:

15.10.97

URIC ACID FS*

TBHBA

Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 302 023 R1 1 x 800ml + R2 1 x 200 ml 10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TBHBA“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and 2,4,6-Tribromo-3-hydroxybenzoic acid (TBHBA) to Chinonimine.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with distilled water.


R1: Phosphate buffer pH 7.0 100 mmol/l TBHBA (2,4,6-Tribromo-3-Hydroxy-

benzoic acid) 1 mmol/l

R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 2 KU/l Uricase > 30 U/l Standard: 6 mg/dl (357 µmol/l)

Notes

Ascorbic acid interferes.


Serum: Men: 3.4 - 7.0 mg/dl (200 - 420 µmol/l) Women: 2.4 - 5.7 mg/dl (140 - 340 µmol/l) Urine: 250 - 750 mg/24 h (1.5 - 4.5 mmol/24 h)

References

1. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U., Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384

2. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry, Principles and Technics, 2

nd edition, Harper & Row Publishers

Inc., Hagerstown Maryland 1974, 534 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 - 27 4. Town, M.-H., Gehm, S., Hammer, B., Ziegenhorn, J.,

J. Clin. Chem. Clin. Biochem., 23, (1985), 591 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TBHBA Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 20 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 300 Reagents A/B (l) 300


Serum Parameters Tests Name URIC ACID Sample Volume (l) 6




CALIBRATOR:

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Fosfatase Ácida Targa - Kovalent · ALAT (GPT) FS (IFCC mod.) Order information Cat. No. 1 2701 .....

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