OnSite HBsAg /HCV Ab Rapid Test Detects HBV and HCV Infection in 1 run.
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Transcript of 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
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
[email protected] [email protected]@ctkbiotech.com San Diego, CA 92121, USA
CTK contact information:
Offices in:
Faisalabad Islamabad LahoreKarachiPrewash