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

BACKGROUND

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.

OBJECTIVES AND STUDY DESIGN

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.

RESULTS

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.

CONCLUSIONS

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.