Clinical performance of two new, fully integrated molecular platforms used for HIV-1, HBV and HCV viral load analysis, the NeuMoDx 288 and the Alinity m

K Mourik; S A Boers; A L van Rijn; J C P Thijssen; E Wessels; E C J Claas

doi:10.1016/j.jcv.2022.105376

Clinical performance of two new, fully integrated molecular platforms used for HIV-1, HBV and HCV viral load analysis, the NeuMoDx 288 and the Alinity m

J Clin Virol. 2023 Mar:160:105376. doi: 10.1016/j.jcv.2022.105376. Epub 2023 Jan 2.

Authors

K Mourik¹, S A Boers¹, A L van Rijn¹, J C P Thijssen¹, E Wessels¹, E C J Claas²

Affiliations

¹ Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
² Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: E.C.J.Claas@lumc.nl.

PMID: 36640531
DOI: 10.1016/j.jcv.2022.105376

Abstract

Background: Viral load (VL) determination in patients with human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) is essential for proper patient management and follow-up. New molecular platforms have been developed to fully automate these diagnostic assays.

Objective: Evaluation of the clinical performance of HIV-1, HBV and HCV VL assays on the Alinity m (Abbott) and NeuMoDx (Qiagen) molecular platforms.

Method: Test panels of the three viruses have been compiled of 100 plasma and/or serum samples per target containing non-detectable, non-quantifiable and quantifiable VLs. All samples were retrospectively tested on the Alinity m and NeuMoDx platforms according to manufacturers' instructions.

Results: A total of 74, 86 and 66 samples with valid results for both platforms were included in the HIV-1, HBV and HCV analysis respectively. Overall qualitative agreement of the assays on both platforms was 78% for HIV-1, 93% for HBV and 100% for HCV. Quantitative agreement (less than 0.5 log difference) was shown to be 68% for HIV-1, 68% for HBV and 94% for HCV.

Conclusion: The Alinity m and NeuMoDx HCV assay have a comparable performance. Quantification differences in the HIV-1 assay were mostly apparent in the lower VLs and under-quantification of the NeuMoDx HBV assay was observed.

Keywords: Fully automated molecular platform; HBV; HCV; HIV; Viral load testing.

MeSH terms

HIV Infections* / diagnosis
HIV-1*
Hepacivirus
Hepatitis B virus
Hepatitis B* / diagnosis
Hepatitis C* / diagnosis
Humans
Retrospective Studies
Sensitivity and Specificity
Viral Load / methods