Evaluating the aptima HIV-1 quant Dx, HCV quant Dx and HBV quant assays against the Abbott HIV-1, HCV and HBV RealTime assays

• Published in: Journal of clinical virology 2018-09, Vol.106, p.7-10
• Main Authors: May, Shoshanna, Adamska, Ewelina, Tang, J.W.
• Format: Article
• Language: English
• Subjects: Biological Specimen Banks; Genotype; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis B - diagnosis; Hepatitis B virus - genetics; Hepatitis B virus - isolation & purification; Hepatitis C - diagnosis; HIV Infections - diagnosis; HIV-1 - genetics; HIV-1 - isolation & purification; Humans; Molecular Diagnostic Techniques; Nucleic Acid Amplification Techniques - methods; Reagent Kits, Diagnostic; Reference Standards; Sensitivity and Specificity; Viral Load - methods
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2018.06.015

•HIV, HBV, HCV viral load testing is important for monitoring response to therapy.•Multiple semi-automated platforms and assays are available that can save time.•The Abbott m2000 and Hologic Panther HIV, HBV, HCV viral load assays were compared.•The two assays performed similarly but the Panther assays are random access.•The Panther assays also have less hands-on time and a faster turnaround time. Viral load measurement is routine for the management of patients infected with HIV, HCV or HBV, using sensitive, quantitative, nucleic acid amplification tests (NAATs). However, platforms are not equivalent in terms of turnaround time, random access capability and operator hands-on time. We compared the performance of the Hologic Panther transcription-mediated amplification based Aptima assays for HIV, HBV and HCV viral load measurement with the corresponding Abbott m2000 RealTime assays. All Aptima assays were run according to the manufacturer’s instructions, on archived patient samples for HIV (n = 251 including subtypes 01_AE, A (A1), B, BG recombinant, C CRF02_AG and G), HBV (n = 117 including genotypes A, B, C and D) and HCV (n = 82 including genotypes 1, 2, 3 and 4). Additional testing was performed with WHO international standards and expanded HIV-1 subtype and HCV NIBSC genotype panels. The Hologic Panther Aptima assays for HIV-1 RNA, HBV DNA and HCV RNA viral load measurements performed equivalently to the Abbott m2000 RealTime assays. The performance of the Aptima assays was also acceptable on the WHO and NIBSC standards and subtype/genotype panels. The Aptima Panther platform offers equivalent clinical performance for the viral load measurement of these three viruses, with the added benefits of reduced turnaround time, random access capability and reduced ‘hands-on time’ for staff, resulting in a potentially superior workflow for diagnostic laboratories.