OnSite HBsAg /HCV Ab Rapid Test

Detects HBV and HCV Infection in 1 run

Facts of HBV and HCV Infection

• Hepatitis B virus (HBV) and Hepatitis C virus (HCV) are the two most common blood born infectious agents. – About 5% of world population has chronic HBV infection – More than 3% world population is infected by HCV – HCV and HBsAg is often co-infected

• Infected person or asymptomatic carries with HBV and HCV are only reservoir of infection.

• Prompt identification of carries is the key to prevent from HBV and HCV transmission.

Indication of HBsAg and HCV Ab Testing

• Blood donor screening • Preparation test before surgery • Hepatitis diagnosis

HBsAg Is The Marker Of HBV Infection

HCV Antibodies Is The Marker Of HCV Infection

.

Current HBV & HCV Testing Procedure

HBsAg Rapid Test HBsAg ELISA Test HBV PCR Test

HCV Ab Rapid Test HCV Ab ELISA Test HCV PCR Test

A New Cost Effective Test by CTK

OnSite HBsAg/HCV Ab Test Procedure

Result Demonstration

OnSite HBsAg/HCV Ab Rapid Test Performance

Equivalent Sensitivity To The Individual HBsAg And HCV Ab Rapid Tests

Specimens HBsAg positive HCV Ab positive

Tests 1:100 1:200 1:10 1:50

HBsAg > + + N/A

HCV Ab N/A N/A ++ +

HBsAg/HCVLot#1

> + + ++ +

HBsAg/HCVLot#2

> + + ++ +

HBsAg/HCVLot#3

> + + ++ +

Detection Level for HBsAg: As low as 0.5 ng/ml

Performance on clinical specimens

HBsAg/HCV Ab Rapid Test

HCV Ab ELISA Positive Negative Total

Positive 45 0 45

Negative 4 450 454

Total 49 450 499

HBsAg/HCV Ab Rapid Test

HBsAg ELISA Positive Negative Total

Positive 97 0 97

Negative 0 463 463

Total 97 463 560

Relative Sensitivity: 100%, Relative Specificity: 99.1%, Overall Agreement: 99.2%

Detection of HCV

Detection of HBsAg

Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%

Highly Specific

No false positive result on

200 frozen random serum specimens 50 fresh random clinical specimens

No Inferenced By Common Chemicals HBsAg Detection HCV Ab Detection

Control Strong Weak Neg. Strong Weak Neg. Birubin 20mg/dl ++ + - ++ + -

6.7mg/dl ++ + - ++ + -Creatin 442µmol/l ++ + - ++ + -

++ + - ++ + -Glucose 55mmol/l ++ + - ++ + -

++ + - ++ + -Salicylic acid

4.34 mM ++ + - ++ + -1.45 mM ++ + - ++ + -

Heparin 3 U/ml ++ + - ++ + -1 U/ml ++ + - ++ + -

EDTA 3.4uM ++ + - ++ + -1.1uM ++ + - ++ + -

Human IgG

1 g /dl ++ + - ++ + -0.3g/dl ++ + - ++ + -

Citriate sodium

3.8% ++ + - ++ + -1.27% ++ + - ++ + -

No Cross-Reactivity with Hyper Immune Specimens

ANA specimens KB61155 KB64917 KB77964 KB77335 KB80040 KB8008

HBsAg/HCV Lot#1 Negative Negative Negative Negative Negative Negative

HBsAg/HCV Lot#2 Negative Negative Negative Negative Negative Negative

HBsAg/HCV Lot#3 Negative Negative Negative Negative Negative Negative

RF specimens 22 IU/ml 294 IU/ml 2515 IU/ml

HBsAg/HCV Lot#1 Negative Negative Negative

HBsAg/HCV Lot#2 Negative Negative Negative

HBsAg/HCV Lot#3 Negative Negative Negative

HAMA specimens SD3145 SD3135 SD3139 SD3158

HBsAg/HCV Lot#1 Negative Negative Negative Negative

HBsAg/HCV Lot#2 Negative Negative Negative Negative

HBsAg/HCV Lot#3 Negative Negative Negative Negative

Not Cross-Reactivity With Common Infectious Diseases

Diseases Dengue HAV HIV Syphilis TB H. plyloriHBsAg/HCV Lot#1 Negative Negative Negative Negative Negative Negative

HBsAg/HCV Lot#2 Negative Negative Negative Negative Negative Negative

HBsAg/HCV Lot#3 Negative Negative Negative Negative Negative Negative

OnSite: The practical advantages -DRUQ

Detection Advantages Detects HBsAg and HCV Ab in 1 test run Easily accessible specimens serum, plasma, whole blood, suitable for emergency care

Result Advantages HBV and HCV infection within 15 minutes, enabling doctor to take immediate action Highly accurate & reproducible

User Advantages One test procedure for 2 test results Save specimen, reduce work load, and reduce cost!

Quality Advantages Equivalent performance to the individual HBsAg and HCV Ab Rapid Test

Final Message to Doctors

To reduce cost and work load Order

Onsite HBsAg / HCV Ab Rapid Test

Also available of OnSite HIV/Syphilis Ab Rapid Test

For further information about OnSite HBsAg / HAV Ab Rapid Test kits

Exclusive distributor in Pakistan

Info@ctkbiotech.com sales@ctkbiotech.comtech@ctkbiotech.com San Diego, CA 92121, USA

CTK contact information:

Offices in:

Faisalabad Islamabad LahoreKarachiPrewash