Journal of Clinical Virology, Volume 60, Issue 4, August 2014, Pages 336–340

HCV RNA detection in HCV antibody-positive patients with the COBAS® AmpliPrep/COBAS® TaqMan® HCV test, v2.0 in comparison with FDA-approved nucleic acid tests

Ann Butcher, Shagufta Aslam, Pari Hemyari, Ula Cowen, Gabrielle Heilek

Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States

 

Abstract

Background

Analysis of hepatitis C virus (HCV) RNA levels is critical for assessing the efficacy of antiviral therapy and the achievement of a sustained virologic response.

Objective and study design

This study evaluated the clinical performance of the COBAS® AmpliPrep/COBAS®TaqMan® HCV quantitative test, version 2.0 (TAQMAN v2.0) with the COBAS®AmpliPrep/COBAS® TaqMan® HCV quantitative test, version 1.0 (TAQMAN v1.0), the VERSANT® HCV qualitative assay (VERSANT), and the COBAS® AMPLICOR HCV test, v2.0 (AMPLICOR) qualitative test for the detection of HCV RNA in serum or EDTA plasma from patients who are or have been infected with HCV and carry HCV antibodies.

Results

A total of 277 participants were evaluable for the percent agreement analysis of the TAQMAN v2.0 with the VERSANT and with the AMPLICOR. The overall percent agreement between the TAQMAN v2.0 and the VERSANT or the AMPLICOR was 99.3% (95% CI: 97.4%, 99.8%) or 98.9% (95% CI: 96.9%, 99.6%), respectively. The overall percent agreement between the TAQMAN v2.0 and the TAQMAN v1.0 when 267 of the original samples were assessed was 98.9% (95% CI = 96.7%, 99.6%).

Conclusion

The TAQMAN v2.0 demonstrated high correlation with the previously approved HCV RNA quantitative and qualitative tests.

PMID: 24881014

 

Supplement:

Detection of hepatitis C (HCV) RNA is evidence of ongoing active infection. The CDC recommended screening algorithm for Hepatitis C includes HCV RNA testing, particularly for the birth cohort of individuals born between 1945-1965, where an increased frequency of HCV infection has been documented (1). However any new HCV RNA test used to confirm the presence of active infection must be rigorously evaluated against existing tests. HCV RNA tests must be shown to accurately identify people infected with HCV and distinguish these from people who do not have active infection (either because the infection has resolved or because they have never been infected).

The TAQMAN v2.0 test was developed to improve several performance features of the first version of the TAQMAN assay. TAQMAN v2.0 more accurately quantifies HCV RNA across all HCV genotypes, including specimens with rare polymorphisms than the TAQMAN assay2.

Performance of the TAQMAN v2.0 test in HCV antibody positive patients

The original clinical study reported in the abstract above compared the performance of the TAQMAN v2.0 test with those of two FDA-approved HCV RNA tests (VERSANT and AMPLICOR) in HCV antibody positive patients. In this population, the results of the TAQMAN v2.0 test were consistent with the results on the FDA-approved tests (99.3 % and 98.9% results overall were in agreement with the VERSANT and AMPLICOR tests respectively). TAQMAN v2.0 distinguished patients with active HCV infection from those in whom the infection had resolved; i.e. there was a high Positive Percent Agreement and Negative Percent Agreement with results from the approved tests. (Table 1)

 

Table 1: Comparison of the TAQMAN v2.0 With the VERSANT and the AMPLICOR HCV tests

GH TAB1

CI = confidence interval.

*HCV RNA was detected on the CAP/CTM HCV Test v2.0, but was <15 IU/mL.

$HCV RNA was detected on the CAP/CTM HCV Test v2.0, but was <15 IU/mL.

 

 

Performance of the TAQMAN v2.0 test in patients with non-HCV-related liver disease.

A further study was undertaken to evaluate the performance of TAQMAN v2.0 test in 205 samples from patients with liver disease that was not due to HCV. These included patients with viral hepatitis due to HBV and those with one of a range of non-viral liver diseases including those due to metabolic or autoimmune conditions.

The demographic distribution of the samples collected for non-HCV related liver diseases reflected subjects in their 4th and 5th decade of life who were under a physician’s care for liver disorders common in this age group.

TAQMAN v2.0 results were negative in all 205 samples tested and the overall negative percent agreement (NPA) was 100% (95% exact CI: 98.2%, 100.0%) (Table 2).

 

Table 2: TAQMAN v2.0 results in Patients with Non HCV‑Related Liver Diseases

GH TAB2

a   Negative Percent Agreement: percentage of the number of negative results to the total number of HCV RNA negative specimens among valid test results.

b 95% CI: 95% exact confidence interval.

HBV = hepatitis B virus; HCV = hepatitis C virus; CI = confidence interval; NASH = non-alcoholic steatohepatitis; TAQMAN v2.0= COBAS AmpliPrep/COBAS TaqMan HCV Test, version 2.0.

 

 

In summary, the TAQMAN v2.0 demonstrated the ability to specifically determine the absence of HCV in a variety of subjects with symptoms of liver disease due to causes other than active HCV infection and hence the test was shown to be highly specific.

 

Conclusion

TAQMAN v2.0 results were consistent with the results from the FDA-approved VERSANT and AMPLICOR tests in HCV antibody positive patients. In this population, TAQMAN v2.0 accurately distinguished between patients with active and resolved HCV infection.

TAQMAN v2.0 results were highly specific and there were no false positive results in patients with a range of non-HCV liver diseases

 

References

  1. Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945–1965(MMWR 2012;61(RR04);1-18)
  2. Vermehren J, Colucci G, Gohl P, Hamdi N, et al. Development of a Second Version of the Cobas AmpliPrep/Cobas TaqMan Hepatitis C Virus Quantitative Test with Improved Genotype InclusivityJ . Clin. Microbiol. 2011 49;9: 3309-3315

 

Acknowledgements:  The authors would like to thank June Sunga, Loretta Jones and Alison Murray who participated in the generation of the data shown in the supplement. As well as Dana Duncan, Ann Butcher and Alison Murray for technical review of this publication.

 

Contact:

Gabrielle M. Heilek Ph.D.

Roche Molecular Systems, Inc,

4300 Hacienda Drive

Pleasanton, CA 94588

Tel:         925-730-8429

Fax:        925-730-8988

Mobile:    925-523-1501

Email: gabrielle.heilek@roche.com

 

 

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