PROFICIENCY TESTING REPORT - 岡大バイオバン...
Transcript of PROFICIENCY TESTING REPORT - 岡大バイオバン...
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 2 of 18
Biorepository proficiency testing for the quality control
of biospecimens
Proficiency Testing Provider
IBBL (Integrated Biobank of Luxembourg)
6 Rue Nicolas Ernest Barblé
L-1210 Luxembourg
LUXEMBOURG
Coordinator Fay BETSOU, PhD HDR, IBBL CBS
Contact us Tel: +352 26970 - 520 (Mon-Fri 9 AM-5 PM CET)
Email: [email protected]
Web: http://www.ibbl.lu
Round: PBMC16R1
Preliminary ; Final ; Amended
Date of Round Closure: 21st October 2016
Report Number: PBMC16R1_Report01
Comments (reason for amendment or re-issue):
Participant’s name: Okayama University Hospital Biobank
Participant Code: L261
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Biorepository proficiency testing for the quality control
of biospecimens
SECTION 1 - General Information
Design of the Viable PBMC Isolation Scheme: The Participant proceeded to the collection of one blood tube (any anti-coagulant permitted) from a healthy donor. The Participant isolated the PBMC following his/her routine procedure. The Participant measured the number of PBMC (cells/mL) and prepared up to five PBMC aliquots. Expected viability and cell concentration are the following: Viability: minimum 80%
Cell concentration: between 5*106 and 107 cells/mL of medium.
The Participant proceeded to the freezing of the PBMC aliquots following his/her routine procedure. The isolated PBMC aliquots were shipped back to the PT provider on dry ice in labelled tubes and related data were reported by the Participant through the website http://biospecimenpt.ibbl.lu.
The PBMC viability, early apoptosis/necrosis, number of viable PBMC isolated per mL of blood and PBMC functionality, measured by ELISPOT, for the total PBMCs isolated by each participant, were assessed by IBBL.
Confidentiality: The identities of Participants and their results and performance are kept confidential and are known only to persons involved in the operation of the PT Scheme.
Subcontractors: IBBL is implementing this Program internationally in collaboration with ISBER, the International Society for Biological and Environmental Repositories, based at 375 West 5th Ave, Suite 201, Vancouver, BC, Canada V5Y 1J6. The ISBER PT Advisory Group participates in the development of the annual PT program, in the Value Assignment of the Test Items, and provides advice to PT Participants.
Technical data: For your reference, all information related to the description of the Processing Item is included in the “Processing Item Information Sheet” (PIIS) which was provided to you along with the sample. Extra copies can be downloaded on IBBL’s website (http://www.ibbl.lu/ibbl-services/pt/proficiency-testing-schemes/).
Personalized Advice Service: Advice and educational feedback to Participants is available on demand (please contact IBBL using details on page 1 of this report).
Customer Satisfaction Survey: IBBL seeks the feedback of all Participants, both positive and negative, to be used and analysed to improve its management system, future Schemes, and customer service. Please complete our survey, available online: https://www.surveymonkey.com/r/IBBL2016PT
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Biorepository proficiency testing for the quality control
of biospecimens
SECTION 2 – General Statistics
31 Participants registered for the Viable PBMC Isolation Round performed in 2016.
Geographic Origin of Participants
Country Count %
BELGIUM 2 6
ITALY 1 3
JAPAN 3 10
LUXEMBOURG 1 3
SINGAPORE 2 6
SOUTH AFRICA 2 6
SPAIN 1 3
UNITED STATES 19 61
Type of Facilities
Facility Count %
not specified 21 68
Hospital Laboratory 5 16
Private Laboratory 4 13
University/Academic 1 3
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Biorepository proficiency testing for the quality control
of biospecimens
Anticoagulant used for the blood draw
Anticoagulant Count %
Cell Preparation Tube (CPT) - Na2 Citrate 1 3
Cell Preparation Tube (CPT) - Na2 Heparin 1 3
Citrate dextrose additives (ACD) 5 16
K2 EDTA 11 35
Lithium Heparin 1 3
Sodium Heparin 12 39
Extraction equipment
Extraction Count %
Automatic extraction 1 3
Manual extraction 30 97
Extraction tube
Tube Count %
not specified 1 3
Cell Preparation Tube (CPT) 2 6
LeucoSep Tube 2 6
Other - Please Specify 2 6
SepMate Tube (StemCell) 6 19
Standard conical tube 18 58
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Biorepository proficiency testing for the quality control
of biospecimens
Cryopreservation medium
Medium Count %
Commercial 10 32
Home made 21 68
Cryopreservation method
Method Count %
not specified 1 3
Mr Frosty 14 45
Other - Please Specify 13 42
Progressive Rate Freezer 3 10
Storage temperature after aliquoting
Temperature Count %
-80°C 15 48
Liquid phase of LN2 2 6
Vapor phase of LN2 14 45
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 7 of 18
Biorepository proficiency testing for the quality control
of biospecimens
SECTION 3 – Data Analysis Results and Evaluation of Performance
Statistical Procedure Used
Basic statistical procedures were used to calculate the PBMC extraction efficiency of the Participants. The Isolated PBMC Viability (%), the Isolated PBMC Apoptosis/Necrosis (%), the Isolated Viable PBMC Yield (cells/mL of blood) and Isolated PBMC functionality (ELISPOT) were calculated. For each parameter, the Participants’ mean was considered as the assigned value. The standard deviation was the standard deviation of the Participants. The outliers were calculated with the Grubb’s test, and were excluded from the statistical summaries.
The scoring system is based on deviation from the assigned value.
1. For the Isolated PBMC Viability and the Isolated Viable PBMC Yield, the scoring system is the following:
Deviation from assigned value (z-score) Consensus Score
< –3 standard deviation 3
< –2 standard deviation 2
< –1 standard deviation 1
> -1 and < +1 standard deviation 0
> +1 standard deviation 0
This scoring system highlights the proficiency of Participants to obtain higher yield and viability of cells than the consensus mean.
2. For the Isolated PBMC Apoptosis/Necrosis, the scoring system is the following:
Deviation from assigned value (z-score) Consensus Score
< –1 standard deviation 0
> -1 and < +1 standard deviation 0
> +1 standard deviation 1
> +2 standard deviation 2
> +3 standard deviation 3
This scoring system highlights the proficiency of Participants to obtain lower quantity of apoptotic/necrotic cells than the consensus mean.
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 8 of 18
Biorepository proficiency testing for the quality control
of biospecimens
Isolated Viable PBMC Yield per mL of Blood
YOU SUBMITTED RESULTS WITH THIS METHOD
Expected Results
Panel Composition and expected result (mean values and participant data standard deviations)
Sample Sample content
Mean (10^6 ç/ml blood)
Proficiency testing standard deviation (10^6 ç/ml blood)
All Results
PBMC 1.01 0.78
Your Results
Sample Sample content Your result (10^6 ç/ml blood) Your consensus score
Your Aliquot(s) PBMC 0.37 0
Sum quantitative panel score 0
Your z-score for Isolated Viable PBMC Yield per mL of Blood is -0.821 (Your Aliquot(s)).
Your z-score for Isolated Viable PBMC Yield per mL of Blood has been designated as "accurate" or "very satisfactory".
If your z-score has been designated as "questionable" or "requiring action", some additional feedback may be found at the end of this report.
Your results are shown in green.
Your Aliquot(s) Results
PROLab Plus
Laboratory
L100
L226
L205
L261
L238
L216
L018
L046
L108
L150
L234
L056
L137
L065
L255
L267
L223
L217
L242
L124
L186
L203
L037
L066
L101
L028
L253
L219
L228
L230
L2141
0^6
ç/m
l blo
od
5
0
No. of laboratories: 30No. of outlier values: 1Mean: 1.01 10^6 ç/ml bloodProficiency Testing Standard Deviation: 0.78 10^6 ç/ml blood (Empirical value)
Median: 0.78Minimal value: 0.16Maximal value: 3.98Range: 3.82
B
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Biorepository proficiency testing for the quality control
of biospecimens
Your History of Z-Scores
This is your first participation with this method in the scheme; therefore, no history of your z-scores is available yet.
A history of your z-scores will be available in your future participations.
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Biorepository proficiency testing for the quality control
of biospecimens
Isolated PBMC Viability
YOU SUBMITTED RESULTS WITH THIS METHOD
Expected Results
Panel Composition and expected result (mean values and participant data standard deviations)
Sample Sample content Mean (%) Proficiency testing standard deviation (%)
All Results PBMC 85.2 4.9
Your Results
Sample Sample content Your result (%) Your consensus score
Your Aliquot(s) PBMC 86.0 0
Sum quantitative panel score 0
Your z-score for Isolated PBMC Viability is 0.157 (Your Aliquot(s)).
Your z-score for Isolated PBMC Viability has been designated as "accurate" or "very satisfactory".
If your z-score has been designated as "questionable" or "requiring action", some additional feedback may be found at the end of this report.
Your results are shown in green.
Your Aliquot(s) Results
PROLab Plus
Laboratory
L056
L066
L186
L234
L124
L214
L137
L108
L226
L100
L238
L267
L255
L223
L253
L261
L228
L046
L217
L230
L065
L028
L101
L203
L205
L150
L216
L037
L018
L219
L242
%
100
80
60
No. of laboratories: 30No. of outlier values: 1Mean: 85.2 %Proficiency Testing Standard Deviation: 4.9 % (Empirical value)
Median: 86.0Minimal value: 50.9Maximal value: 94.2Range: 43.2
B
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 11 of 18
Biorepository proficiency testing for the quality control
of biospecimens
Your History of Z-Scores
This is your first participation with this method in the scheme; therefore, no history of your z-scores is available yet.
A history of your z-scores will be available in your future participations.
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Biorepository proficiency testing for the quality control
of biospecimens
Isolated PBMC Apoptosis/Necrosis
YOU SUBMITTED RESULTS WITH THIS METHOD
Expected Results
Panel Composition and expected result (mean values and participant data standard deviations)
Sample Sample content Mean (%) Proficiency testing standard deviation (%)
All Results PBMC 14.95 4.83
Your Results
Sample Sample content Your result (%) Your consensus score
Your Aliquot(s) PBMC 14.20 0
Sum quantitative panel score 0
Your z-score for Isolated PBMC Apoptosis/Necrosis is -0.154 (Your Aliquot(s)).
Your z-score for Isolated PBMC Apoptosis/Necrosis has been designated as "accurate" or "very satisfactory".
If your z-score has been designated as "questionable" or "requiring action", some additional feedback may be found at the end of this report.
Your results are shown in green.
Your Aliquot(s) Results
PROLab Plus
Laboratory
L242
L219
L018
L037
L216
L150
L203
L205
L101
L065
L028
L230
L217
L046
L228
L261
L253
L223
L255
L267
L238
L100
L226
L108
L137
L214
L124
L234
L186
L066
L056
%
50
0
No. of laboratories: 30No. of outlier values: 1Mean: 14.95 %Proficiency Testing Standard Deviation: 4.83 % (Empirical value)
Median: 14.20Minimal value: 5.96Maximal value: 49.31Range: 43.35
B
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 13 of 18
Biorepository proficiency testing for the quality control
of biospecimens
Your History of Z-Scores
This is your first participation with this method in the scheme; therefore, no history of your z-scores is available yet.
A history of your z-scores will be available in your future participations.
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Biorepository proficiency testing for the quality control
of biospecimens
IFN-gamma ELISPOT assay
High spot count (more than 20 spots/200000 cells for CPI)
Low spot count (less than 20 spots/200000 cells for CPI)
CPI Antigen - a pool of protein antigens derived from Cytomegalovirus, Influenza, and Parainfluenza viruses, used as a positive control for the functionality of CD4+ T cells and antigen presenting cells
IFN-gamma ELISPOT assay Number of Participants Your result
High spot count 30 X
Low spot count 1
IFN-gamma ELISPOT assay
High spot count Low spot count
Num
ber
of part
icip
ants
30
28
26
24
22
20
18
16
14
12
10
8
6
4
2
0
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Biorepository proficiency testing for the quality control
of biospecimens
Global Viable PBMC Isolation 2016 Z-Scores For Your Aliquot(s)
PROLab Plus
Z-Score
-3 0 3 -3 0 3 -3 0 3 -3 0 3
Method
IFN
-gam
ma E
LIS
PO
T a
ssay
Isola
ted P
BM
C V
iability
Isola
ted P
BM
C A
popto
sis
/Necro
sis
Isola
ted V
iable
PB
MC
Yie
ld p
er
mL o
f B
lood
Labora
tory
7.120-7.049
3.817
3.033
3.110
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Biorepository proficiency testing for the quality control
of biospecimens
Overview Of Your Z-Scores For All Testing Schemes
PROLab Plus
Z-Score
-3 0 3 -3 0 3 -3 0 3
Round/Sample
DN
AQ
16R
1/T
ube A
DN
AQ
16R
1/T
ube B
DN
AQ
16R
1/T
ube C
Meth
od
DNA Concentration - Spectrofluorometry
Final PBMC16R1 L261 Prepared on: 13 January 2017 Page 17 of 18
Biorepository proficiency testing for the quality control
of biospecimens
Overview Of Your Z-Scores For All Processing Schemes
PROLab Plus
Z-Score
-3 0 3 -3 0 3 -3 0 3 -3 0 3 -3 0 3 -3 0 3
Round/SampleD
NA
BLD
16/A
ll re
sults
DN
AB
LD
16/S
ilica m
em
bra
ne-b
ased
CF
DN
A16/A
ll re
sults
CF
DN
A16/S
ilica-m
em
bra
ne b
ased
PB
MC
16R
1/A
ll R
esults
PB
MC
16R
1/Y
our
Aliq
uot(
s)
Meth
od
PROLab Plus