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Evaluation of a novel in-house HIV-1 genotype drug resistance assay using clinical samples in China

Author(s):

Peijie Gao*, Fengting Yu, Xiaozhen Yang, Dan Li , Yalun Shi , Yan Wang and Fujie Zhang  

Abstract:


Background: HIV drug resistance poses a major challenge for anti-retroviral treatment (ART) and the prevention and control of HIV epidemic.

Objective: The study aims to establish a novel in-house assay with high efficiency, named AP in-house method, that would be suitable for HIV-1 drug resistance detection in China.

Methods: An in-house HIV-1 genotyping method was used to sequence the partial pol gene from 60 clinical plasma samples; the results of our test were compared with a commercial ViroSeq HIV-1 genotyping system.

Results: Among sixty samples, 58(96.7%) were successfully amplified by AP in-house method, five of them harbored viral load below 1,000 copies/ml. The genotype distribution was 43.1% CRF07_BC (25/58), 39.7% CRF01_AE (23/58), 6.9% CRF55_01B (4/58), 5.2% subtype B (3/58) and 5.2% CRF08_BC (3/58). Compared with that of the ViroSeq system, the consistent rate of these nucleotides and amino acids obtained by AP in-house method was up to 99.5 ± 0.4% and 99.5 ± 0.4%, respectively. A total of 290 HIV-1 drug resistance mutations were identified by two methods, including 126 nucleoside reverse transcriptase inhibitors (NRTIs), 145 non-nucleoside reverse transcriptase inhibitors (NNRTIs) and 19 protease inhibitors (PIs) resistance mutations. Out of them, 94.1% (273/290) were completely concordant between the AP in-house method and the ViroSeq system.

Conclusion: Overall, the evaluation of AP in-house method provided comparable results to those of the ViroSeq system on diversified HIV-1 subtypes in China.

Keywords:

HIV-1, Anti-retroviral treatment, Genotype, Drug resistance mutation, Protease Inhibitor, Nucleoside Reverse Transcriptase Inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors

Affiliation:

Beijing Anapure Bioscitific Co. Ltd. Beijing, Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Beijing Anapure Bioscitific Co. Ltd. Beijing, Beijing Anapure Bioscitific Co. Ltd. Beijing, Beijing Anapure Bioscitific Co. Ltd. Beijing, Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital



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