Feasibility and performance evaluations of Alinity m quantitative NAT for HBV and HCV

Abstract

Background

Rapid and accurate testing for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) is essential for management of these infections. Selecting the most appropriate testing methodology entails feasibility considerations of cost and throughput in addition to performance evaluations.

Objective

In this study, we determined the feasibility and analytical performance of Alinity m in comparison with Roche Cobas 6800 for both assays according to College of American Pathologists (CAP) standards, and Clinical and Laboratory Standards Institute (CLSI) guidelines.

Results

Unit costs remain relatively stable until around a monthly test volume of 1200. Below this volume, cost escalation pattern varies, such that at 60 tests/month, unit costs increase 9-fold for tests on Roche Cobas 6800, but relatively modestly (2.5-fold) for tests on Alinity m. The 24-h throughput of Alinity m, however, is lower than that of Roche Cobas 6800. The overall concordance between the Alinity m and Cobas 6800 was 97.5 % (39/40) for HBV and 87.5 % (35/40) for HCV. The reportable range was from 1.765 to 8.460 log IU/mL (58.2 to 2.8 × 10⁸ IU/mL) for HBV, and from 1.975 to 7.250 log IU/mL (94.4 to 1.7 × 10⁷ IU/mL) for HCV. The complete reportable range remained undetermined on account of non-availability of extreme viral titer samples. Both intra and inter-run precision, as evaluated by SD falling within the manufacturer-reported, were within acceptable limits. No evidence of cross-contamination was found.

Conclusion

Alinity m demonstrated acceptable performance in comparison with Roche Cobas 6800 for HBV and HCV NAT. Additionally, it demonstrated suitability for lower throughput labs in terms of unit test costs.