Ortho® HCV Version 3.0 ELISA Test System

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Hepatitis C Testing System

ORTHO® HCV, Version 3.0, ELISA Test System

HCV Genome and Recombinant Proteins

Hepatitis C Testing System

ORTHO® HCV, Version 3.0 ELISA Test System

The specificity of ORTHO HCV Version 3.0 ELISA Test System in low-risk populations is based on a population of blood donors from four different test sites. A total of 33,025 specimens were tested. These consisted of 30,025 specimens from presumably healthy volunteer blood donors (sites 1, 2 and 3) and 3,000 specimens from commercial plasma donors (site 4). Rates of initial and repeat reactivities are shown in the table below. Correlation between initial and repeat reactivity was 87.1%.

Prevalence of Anti-HCV Reactivity in Blood Donors
Site Number Tested Nonreactive Initially Reactive Repeatedly Reactive
1 10,208 10,169 47 (0.46%) 39 (0.38%)
2 9,772 9,722 54 (0.55%) 50 (0.51%)
3 10,045 9,998 54 (0.54%) 47 (0.47%)
4 3,000 2,987 16 (0.53%) 13 (0.43%)
Total 33,025 32,876 171 (0.52%) 149 (0.45%)


Specimens repeatedly reactive by ELISA were tested by supplemental strip immunoblot assay (SIA). Upon removal of specimens that were positive or indeterminate by SIA, specificity* in this low prevalence population was 99.95% (5 units per 10,000 donations).

*Specificity was calculated as follows: Specificity = (TN/TN+FP)

  • Where TN = true negatives, that is, the number of specimens nonreactive by ELISA.
  • Where FP=false positives, that is, repeatedly reactive by ELISA and negative by SIA.
Hepatitis C Testing System

ORTHO® HCV, Version 3.0 ELISA Test System

Performance Data: Detection of Anti-HCV Seroconversion in Transfusion Recipients with Transfusion-Associated NANBH (TA-NANBH)

Serial specimens collected from 21 patients with clinically documented TA-NANBH were tested at clinical (patient) site 2 by both ORTHO HCV Version 3.0 ELISA Test System and ORTHO HCV 2.0 ELISA Test System. HCV Version 3.0 detected seroconversion to anti-HCV in earlier bleeds in 5/21 (24%) patients. HCV 2.0 detected seroconversion to anti-HCV in an earlier bleed in 1/21 (5%) patients. In 15 patients, HCV Version 3.0 and HCV 2.0 detected anti-HCV in the same serial bleed.

Difference in Detection of Anti-HCV in 21 TA-NANBH Patients
Patient Number Earlier Detection by
HCV ELISA
Difference in Detection
Bleeds (Days)
1 HCV Version 3.0 2 (20)
2 HCV Version 3.0 1 (34)
3 HCV Version 3.0 1 (27)
4 HCV Version 3.0 2 (20)
5 HCV Version 3.0 2 (29)
6 HCV 2.0 1 (35)

There was no difference in the time to detection of anti-HCV ELISA reactivity in the remaining 15 patients.

The Ortho® HCV Version 3.0 ELISA Test System uses three recombinant antigens developed by Chiron® Corporation to detect antibodies to hepatitis C virus (HCV) with excellent sensitivity and enhanced specificity (99.95 percent). These antigens (c22-3, c200 and NS5) cover 60 percent of the HCV genome, allowing broad detection of HCV antibodies. Early detection of HCV helps to eliminate potentially infectious units and improves the safety of the world’s blood supply.

Ortho HCV Version 3.0 ELISA Test System
Ortho HCV Version 3.0 ELISA Test System

930740
480 tests using 3 recombinant antigens developed by Chiron® Corp. to detect antibodies to hepatitis C virus

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Ortho HCV Version 3.0 ELISA Stop Solution
Ortho HCV Version 3.0 ELISA Stop Solution

933040
2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system

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Ortho HCV Version 3.0 ELISA Wash Buffer
Ortho HCV Version 3.0 ELISA Wash Buffer

933730
6 x 150 mL wash buffer for Ortho HCV ELISA test system

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