OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

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OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run

Transcript of OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

Page 1: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

OnSite HBsAg /HCV Ab Rapid Test

Detects HBV and HCV Infection in 1 run

Page 2: 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.

Page 3: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

Indication of HBsAg and HCV Ab Testing

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

Page 4: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

HBsAg Is The Marker Of HBV Infection

Page 5: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

HCV Antibodies Is The Marker Of HCV Infection

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Page 6: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

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

Page 7: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

A New Cost Effective Test by CTK

Page 8: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

OnSite HBsAg/HCV Ab Test Procedure

Page 9: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

Result Demonstration

Page 10: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

OnSite HBsAg/HCV Ab Rapid Test Performance

Page 11: OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.

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

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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%

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Highly Specific

No false positive result on

200 frozen random serum specimens 50 fresh random clinical specimens

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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% ++ + - ++ + -

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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

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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

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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

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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

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

Exclusive distributor in Pakistan

[email protected] [email protected]@ctkbiotech.com San Diego, CA 92121, USA

CTK contact information:

Offices in:

Faisalabad Islamabad LahoreKarachiPrewash