{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:09:45Z","timestamp":1785409785359,"version":"3.56.0"},"reference-count":27,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/501100004826","name":"Natural Science Foundation of Beijing Municipality","doi-asserted-by":"publisher","award":["L234054, L244069"],"award-info":[{"award-number":["L234054, L244069"]}],"id":[{"id":"10.13039\/501100004826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>HIV-1 viral load testing serves as a critical tool for monitoring antiretroviral therapy efficacy and detecting acute HIV-1 infections. This study evaluated the precision, linearity, and clinical performance of 12 commonly used HIV-1 viral load testing kits in China (including seven domestic and five imported kits). Precision analysis revealed that 11 kits achieved intra-assay coefficients of variation (CV%) below 5% for high and medium concentration standards at 10,000 and 1,000 IU\/mL, respectively, while only 4 kits maintained comparable precision at low concentration standards (100 IU\/mL). All kits showed excellent linear performance across their dynamic ranges (R\u00b2 = 0.9924\u20130.9999) and effectively covered the major HIV-1 subtypes circulating in China. Correlation analysis of clinical samples showed strong associations (R\u00b2 &gt;0.70) in 49 out of 66 kit-pair comparisons, with Bland-Altman agreement analysis confirming good consistency between different kits. Notably, domestic Kit B exhibited minimal deviation (0.004 log10 IU\/mL) compared to leading imported assays. Point-of-care testing kits demonstrated performance comparable to laboratory-based systems. However, observed variability in low viral load quantification highlights the need for improved precision to meet stringent clinical requirements for viral suppression monitoring at 50 copies\/mL. These findings validate the reliability of domestic kits for clinical application while suggesting further enhancement in low-level viremia detection capabilities.<\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>HIV-1 viral load (VL) testing is extremely important in monitoring the efficacy of antiretroviral therapy and diagnosing acute HIV-1 infections. In China, the growing demand for nucleic acid testing (NAT) and rapid development of HIV-1 NAT technology have led to the approval of 15 HIV-1 VL kits by 2024, but their performance remains understudied. This study comprehensively evaluates 12 widely used HIV-1 VL kits (seven domestic and five imported) in China, demonstrating high precision, linearity, and clinical accuracy across prevalent HIV-1 subtypes in China. Notably, domestic kits exhibited a strong correlation with imported kits, validating their reliability for clinical use. However, variability in low VL quantification highlights challenges in meeting the stringent suppression threshold of 50 copies\/mL. These findings provide evidence for optimizing HIV-1 NAT strategies, supporting the adoption of cost-effective domestic kits, and guiding future improvements for low-level viremia monitoring.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.03218-24","type":"journal-article","created":{"date-parts":[[2025,5,23]],"date-time":"2025-05-23T09:00:43Z","timestamp":1747990843000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":4,"title":["A comparative performance evaluation of 12 HIV-1 viral load testing asssays: advancing the clinical application of HIV-1 nucleic acid testing in China"],"prefix":"10.1128","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-9554-2043","authenticated-orcid":false,"given":"Yu","family":"Wang","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pinliang","family":"Pan","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenge","family":"Xing","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Zhang","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boxue","family":"Han","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cong","family":"Jin","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04wktzw65","id-type":"ROR","asserted-by":"publisher"}],"name":"National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS\/STD Control and Prevention, Chinese Center for Disease Control and Prevention","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.18.228890"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001495"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw697"},{"key":"e_1_3_4_5_2","first-page":"16","volume-title":"National guideline for detection of HIV\/AIDS","author":"Chinese Center For Disease Control And Prevention","year":"2020","unstructured":"Chinese Center For Disease Control And Prevention. 2020. 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