Application of HIV-1 nucleic acid test to indeterminate and negative cases detected by HIV antibody confirmatory test
WANG Xuqin1, LIN Yi1, YU Xiaolei1, DONG Yuan1, TAO Jing2, TANG Yiming3, HONG Liang2, WU Jiajin3, FENG Wanqing1, LIU Changhe1, LIN Qianru1, NING Zhen1, SHEN Xin1, PAN Qichao1
1. Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336, China; 2. Hongkou District Center for Disease Control and Prevention, Shanghai 200082, China; 3. Songjiang District Center for Disease Control and Prevention, Shanghai 201620, China
Abstract：Objective To clarify the scale of people living with HIV who can be diagnosed by HIV-1 nucleic acid test among indeterminate or negative cases detected by antibody confirmatory test in Shanghai Municipality, and to explore the value of performing routine nucleic acid test in increasing the detection of infected individuals. Methods Quantitative HIV-1 nucleic acid tests were performed on remaining samples (multi-source analysis) of 136 indeterminate and 210 negative cases detected in three laboratories for HIV antibody confirmatory test in Shanghai Municipality, and analyses on the results and the sample sources were conducted. According to the preliminary results, a pilot study on HIV-1 nucleic acid test was performed at a HIV voluntary counseling and testing site (VCT site). Quantitative detection of HIV-1 nucleic acid and qualitative detection of HIV-1 DNA were carried out on samples with antibody confirmatory indeterminate and negative results, and CD4+T lymphocytes of cases that could be diagnosed based on HIV-1 viral load were tested. Results From February 2021 to February 2022, HIV-1 nucleic acid quantitative tests were performed on samples from multi-sources. Of the HIV-1 viral loads of 136 confirmatory indeterminate samples, 24 (17.7%) samples exceeded 5,000 CPs/ml and 2 (1.5%) were detected but less than 5,000 CPs/ml. Of the HIV-1 viral loads of 210 confirmatory negative samples, 4 (1.9%) exceeded 5,000 CPs/ml. The proportion of antibody-indeterminate samples from VCT with detectable HIV-1 nucleic acid results (85.7%) was higher than that from other sources. According to the above-mentioned results, a VCT pilot study was carried out from January to September in 2022. Of the 84 HIV antibody screening reactive samples, 70 were confirmed positive. Eight (57.1%) of the 14 cases with indeterminate or negative results of antibody confirmatory test could be diagnosed through nucleic acid test, accounting for 10.3% of the cases reported in the same period. Conclusion Under the current framework that HIV antibody confirmatory test works as the dominant supplementary test method, it is necessary to perform HIV-1 nucleic acid test on those with indeterminate results in HIV antibody confirmatory test. HIV-1 nucleic acid test makes an important contribution to the detection of HIV infected individualsatVCT sites, and the workflow that includes nucleic acid detection has a strong operability in grass-roots laboratories for HIV confirmatory test.
王绪琴, 林怡, 郁晓磊, 董原, 陶静, 唐益明, 洪亮, 吴佳瑾, 冯琬清, 刘长河, 林倩茹, 宁镇, 沈鑫, 潘启超. HIV-1 核酸检测在抗体确证不确定和阴性病例中的应用研究[J]. 实用预防医学, 2023, 30(12): 1425-1429.
WANG Xuqin, LIN Yi, YU Xiaolei, DONG Yuan, TAO Jing, TANG Yiming, HONG Liang, WU Jiajin, FENG Wanqing, LIU Changhe, LIN Qianru, NING Zhen, SHEN Xin, PAN Qichao. Application of HIV-1 nucleic acid test to indeterminate and negative cases detected by HIV antibody confirmatory test. , 2023, 30(12): 1425-1429.
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