Comparison of the cobas Human Immunodeficiency Virus 1 (HIV-1) Test Using the cobas 4800 System With COBAS AmpliPrep/COBAS TaqMan HIV-1 Test and Abbott RealTime HIV-1 Assay and Performance Evaluation of cobas HIV-1

• Published in: American journal of clinical pathology 2019-10, Vol.152 (5), p.558-562
• Main Authors: Shin, Kyung-Hwa, Lee, Hyun-Ji, Lee, Jin Hyeon, Chang, Chulhun L, Kim, Hyung-Hoi
• Format: Article
• Language: English
• Subjects: Anti-Retroviral Agents - therapeutic use; Comparative analysis; Correlation analysis; HIV; HIV Infections - blood; HIV Infections - drug therapy; HIV Infections - virology; HIV testing; HIV-1 - genetics; Human immunodeficiency virus; Humans; Limit of Detection; Measurement; Performance evaluation; Real-Time Polymerase Chain Reaction - instrumentation; Real-Time Polymerase Chain Reaction - methods; RNA, Viral - blood; Sensitivity and Specificity; Viral Load - instrumentation; Viral Load - methods; Viremia
• ISSN: 0002-9173; 1943-7722
• DOI: 10.1093/ajcp/aqz075

Abstract Objectives To compare quantified human immunodeficiency virus type 1 (HIV-1) viral load quantified using the cobas HIV-1 test with that obtained using the CAP/CTM HIV-1 and Abbott RealTime HIV-1 tests and evaluate the performance of cobas HIV-1 using the cobas 4800 system. Methods Clinical samples (n = 123) were quantitatively analyzed using the CAP/CTM HIV-1, Abbott RealTime HIV-1, and cobas HIV-1 tests, and the precision, linearity, and limit of detection of the cobas HIV-1 test were evaluated. Results Comparable results were obtained by both methods: ([log CAP/CTM HIV-1 value] = 0.979 * [log cobas HIV-1 test value] + 0.034) and ([log Abbott RealTime HIV-1 value] = 0.985 * [log cobas HIV-1 test value] + 0.027). cobas HIV-1 test results for 89.4% and 93.5% were within 0.5 log10 IU/mL of the CAP/CTM HIV-1 and Abbott RealTime HIV-1 results, respectively. Conclusions The cobas HIV-1 test showed good performance, and its results correlated well with those of other two tests.