What is FREND?Summary of AdvantagesThe Principle of ReactionThe TechnologyTest for Prostate Specific AntigenPerformance CharacteristicsHow to Use FREND PSA KitCorrelation with Commercial PSA EquipmentsAssay Table in 2010Specifications

Index

What is FREND ?Fluorescence Response Enhanced Novel Diagnostics

• The FREND is designed by LOC (Lab-on-a-chip) based technology

• For RAPID and QUANTITATIVE immunoassay using small sample volume

• Innovative platform developed

Summary of Advantages

Fast : Loading Reading Result, Test in an Instant (5min)

Accurate : Ensure the Accuracy (CV 5 ~ 7%)

Compact : Small & Light Weight

Sample : Plasma/Serum 30㎕

The Principle of Reaction

Sample buffer & conjugate buffer are treated on the settled position and dried.

BAvidin

Biotinylated Capture Antibody

PSA

DarkRedF. P.

Antibody detector coupledFluorescence Particle

Slide

Test zone

Sample Inlet

ConjugateZone

TestZone

ReferenceZone

Plasma / Serum

5min

The TechnologyMEMS for Device – Membrane Free

Revolutionary platform; Sample, reaction and absorption pads have been replaced by several micro-fluidic components which have been optimized for a FRENDTM de-vice.

Membrane-free technology ; No need for sample or conjugate pad

Lung24%

Prostate13%

Colorectal10%

Oesophagus6%

Pancreas5%

Stomach4%

Bladder4%

All leukaemias3%

Kidney3%

Non-Hodgkin lymphoma

3%

Other25%

All malignant neoplasms - 80,907

Test for Prostate Specific AntigenThe Risk of Prostate Cancer

192,280 patients were newly diagnosed with prostate cancer*).

27,360 patients died due to prostate cancer*).

Worldwide, 670,000 men were newly diagnosed with prostate cancer in 2008**).

Prostate cancer has the second highest mortality rate, after lung cancer.

One out of six men may be diagnosed with prostate cancer in their lifetime.

One out of 35 men may lose their life due to prostate cancer.

*)The American Cancer Society (ACS), 2009**)European Randomized Study of Screening for Prostate Cancer (ERSP), 2008

Test for Prostate Specific Antigen

Prostate-Specific Antigen (PSA) is a tumor marker specific to the prostate PSA takes a very important role in early diagnosis of prostate cancer In general, less than 4ng/ml is regarded as the normal value of PSA

30~35% men (PSA level is over 4ng/ml) may be diagnosed with prostate cancer A PSA level over 10ng/ml has a 50% chance in a prostate cancer diagnosis.

The FDA has confirmed that a PSA test is effective in the detection of prostate cancer

when used in combination with a digital rectal examination (DRE) in men aged 50 years

or older***)

***)National Cancer Institute

Performance Characteristics

FRENDTM PSAMeasurable Ranges: 0.5 ~ 60ng/mL

Cut-Off : PSA 4ng/mL

Reaction Time: about 5min

Sample Volume : Plasma/Serum 30㎕Sensitivity : 99%

CV (coefficient of variation) : 5~7%

How to Use FRENDTM PSAStep1. Step 2. Step 3.

Display Quantitative Result on the Screen

Loading Reading Result

Correlation withCommercial PSA Equipments

0 5 10 15 20 25 3005

10152025303540

f(x) = 1.521411052799 x − 0.414407041834R² = 0.953800906733794

FREN

D P

SA c

on.(n

g/㎖)

Commercial equipment A (ng/㎖ )

0 5 10 15 20 25 30 35 4005

10152025303540

f(x) = 1.084189360844 x − 0.134263221421R² = 0.947451697168615

FREN

D P

SA c

on.(n

g/㎖)

Commercial equipment B (ng/㎖ )

The correlation of PSA determined by FRENDTM against Laboratory resultsR2 value is more than 0.94

SpecificationsFront Side Back Mobile PrinterPSA Kit Q.C device

Electrical ratingVoltage: AC100 ~ 240 VCurrent: 1.0 AFrequency: 50 ~ 60 Hz

OutputVoltage: DC12 VCurrent: 2.5 AMedical power supply

Dimensions Size: 240 mm X 260 mm X 175 mm (W x L X H)

Weight 3 Kg

Operating condition Temperature: 10 ℃ ~ 40 ℃Humidity: 30 % ~ 80 %

Storage condition Temperature: 0 ℃ ~ 50 ℃Humidity: 20 % ~ 85 %

User interface 7’’ Touch screen

Mobile Printer (optional)Size: 75 mm X 103 mm X 44.3 mmWeight: 237 gPrinting Speed: 50 mm/sec

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