Detection limit of architect hepatitis C core antigen assay in correlation with HCV RNA, and renewed confirmation algorithm for reactive anti-HCV samples

Abstract

Background: hepatitis C infections are detected by anti-HCV screening tests. Reactive anti-HCV results give no information about the presence or absence of hepatitis C viruses, or of unspecific reactivity. To obtain information about the viral load, HCV RNA measurements, following a reactive anti-HCV result, are performed in well equipped and specialised laboratories. Anti-HCV immunoblots are the only means to exclude non specific reactivity. The measurement of HCV core antigen (HCV-Ag), as an alternative to HCV RNA, is discussed, as it can be analysed on the same instrument as anti-HCV.

Objectives: The detection limit of HCV-Ag is crucial to use it in lieu of HCV RNA, in regard of the different genotypes. A renewed algorithm is proposed to exclude unspecific reactivity of anti-HCV.

Study designs: Samples were tested on Architect i2000SR (Abbott) for anti-HCV and HCV-Ag. HCV RNA measurements were obtained by Cobas Ampliprep/Taqman (Roche) or m2000rt(®) (Abbott).

Results and conclusions: Comparison between HCV-Ag and HCV RNA from 126 samples of 101 patients with chronic hepatitis C gave linear regression R(2) 0.89, slope 0.885 and intercept -2.258, which were independent of the genotypes. The detection limit of HCV-Ag was between 2.4 and 4.5 Log(10)IU/mL. A renewed algorithm for confirmation of reactive anti-HCV results is proposed: active or resolved hepatitis C infections or false reactivity can be differentiated by sequenced reflex testing due to HCV-Ag, anti-HCV immunoblot and HCV RNA.

Keywords: Architect; CV%; EDTA; Ethylene diaminetetraacetic acid; HCV Ag; HCV PCR; HCV RNA; HCV core antigen; HCV genotype; HCV viral load; Hepatitis C; anti-HCV; coefficient of variation; hepatitis C virus core antigen; hepatitis C virus ribonucleic acid.