{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T13:28:51Z","timestamp":1766150931007,"version":"3.48.0"},"reference-count":33,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T00:00:00Z","timestamp":1766102400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Timely diagnosis of acute HIV infection (AHI) is critical for curbing transmission. However, the diagnostic window prior to antibody development limits the utility of conventional serological assays. Conventional laboratory-based nucleic acid testing (LABT) is often hindered by operational complexity and long turnaround times. Point-of-care nucleic acid testing (POCT) provides a rapid alternative.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicenter cross-sectional study enrolled 1,829 adults from 13 cities in Jiangsu Province and Kunming, Yunnan Province, who had reactive screening results but negative or indeterminate Western blot outcomes. The diagnostic accuracy, quantitative correlation, and agreement of the POCT (Xpert\u00ae HIV-1 Viral Load point-of-care test) were compared with LABT using the Roche COBAS TaqMan v2.0 or Abbott RealTime HIV-1 assays, with follow-up seroconversion serving as the reference standard. Turnaround time from initial screening to NAT result reporting was compared using Kaplan\u2013Meier analysis. Laboratory staff perceptions of POCT usability were evaluated via questionnaire.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Using follow-up seroconversion as a reference, POCT demonstrated a sensitivity of 98.87% and specificity of 100.00%, with almost perfect agreement with LABT (99.76%, Cohen\u2019s\n                      <jats:italic>\u03ba<\/jats:italic>\n                      \u202f=\u202f0.994). Quantitative viral load results exhibited strong correlation between POCT and LABT (\n                      <jats:italic>r<\/jats:italic>\n                      \u202f=\u202f0.89), with 94.64% of paired measurements falling within the limits of agreement. POCT significantly reduced the median time from initial screening to result reporting compared to LABT (7 vs. 14\u202fdays,\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.001) and increased the likelihood of results being returned within 7\u202fdays (Hazard Ratio\u202f=\u202f2.29,\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.001). Most laboratory personnel reported ease of use (30\/33, 90.9%) and a preference for the POCT workflow (21\/33, 63.6%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The Xpert HIV-1 POCT provides a highly accurate and rapid alternative to LABT for diagnosing AHI in China. Its implementation can dramatically shorten diagnostic delays, potentially reducing loss to follow-up and onward transmission, thus offering significant value within the national HIV diagnostic framework.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fpubh.2025.1707432","type":"journal-article","created":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T13:26:30Z","timestamp":1766150790000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China"],"prefix":"10.3389","volume":"13","author":[{"given":"Mingzhu","family":"Niu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoqin","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuhua","family":"Shi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng","family":"Guan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lijuan","family":"Dong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huichao","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Desheng","family":"Huang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cong","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,12,19]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"2492208","DOI":"10.1080\/22221751.2025.2492208","article-title":"Grand challenges on HIV\/AIDS in China - the 5th symposium, Yunnan 2024","volume":"14","author":"Chen","year":"2025","journal-title":"Emerg Microbes Infect"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"e2105904","DOI":"10.1002\/advs.202105904","article-title":"Virus detection: from state-of-the-art laboratories to smartphone-based point-of-care testing","volume":"9","author":"Xiao","year":"2022","journal-title":"Adv Sci (Weinh)"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1351","DOI":"10.1093\/infdis\/jiv430","article-title":"Programmatic implications of acute and early HIV infection","volume":"212","author":"Suthar","year":"2015","journal-title":"J Infect Dis"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"1943","DOI":"10.1056\/NEJMra1011874","article-title":"Acute HIV-1 infection","volume":"364","author":"Cohen","year":"2011","journal-title":"N Engl J Med"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"e59906","DOI":"10.1371\/journal.pone.0059906","article-title":"False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes","volume":"8","author":"Shanks","year":"2013","journal-title":"PLoS One"},{"key":"ref6","year":"2020"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"3295","DOI":"10.1002\/jmv.26295","article-title":"Multicenter evaluation of Xpert HIV-1 viral load assay for HIV quantification in China","volume":"92","author":"Liu","year":"2020","journal-title":"J Med Virol"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"47","DOI":"10.3810\/pgm.2005.03.1600","article-title":"Rapid HIV testing. Wait time reduced from days to minutes","volume":"117","author":"Keenan","year":"2005","journal-title":"Postgrad Med"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"e229","DOI":"10.1016\/s2352-3018(19)30402-3","article-title":"Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial","volume":"7","author":"Drain","year":"2020","journal-title":"Lancet HIV"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"e0062024","DOI":"10.1128\/jcm.00620-24","article-title":"Evaluation of a point-of-care rapid HIV antibody test with insights into acute HIV symptomatology in a population with low prevalence","volume":"62","author":"Bui","year":"2024","journal-title":"J Clin Microbiol"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"e373","DOI":"10.1016\/s2352-3018(19)30033-5","article-title":"Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries","volume":"6","author":"Bianchi","year":"2019","journal-title":"Lancet HIV"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"e0213865","DOI":"10.1371\/journal.pone.0213865","article-title":"Performance and usability of Cepheid GeneXpert HIV-1 qualitative and quantitative assay in Kenya","volume":"14","author":"Bwana","year":"2019","journal-title":"PLoS One"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"3227","DOI":"10.1128\/jcm.01021-17","article-title":"Field evaluation of performance of Alere and Cepheid qualitative HIV assays for pediatric point-of-care testing in an academic hospital in Soweto, South Africa","volume":"55","author":"Murray","year":"2017","journal-title":"J Clin Microbiol"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"e0209778","DOI":"10.1371\/journal.pone.0209778","article-title":"Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis","volume":"13","author":"Opollo","year":"2018","journal-title":"PLoS One"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"3050","DOI":"10.1128\/jcm.01594-16","article-title":"Point-of-care Cepheid Xpert HIV-1 viral load test in rural African communities is feasible and reliable","volume":"54","author":"Moyo","year":"2016","journal-title":"J Clin Microbiol"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1016\/j.jcv.2016.04.014","article-title":"Multi-site clinical evaluation of the Xpert(\u00ae) HIV-1 viral load assay","volume":"80","author":"Jordan","year":"2016","journal-title":"J Clin Virol"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"e25677","DOI":"10.1002\/jia2.25677","article-title":"Point-of-care testing can achieve same-day diagnosis for infants and rapid ART initiation: results from government programmes across six African countries","volume":"24","author":"Boeke","year":"2021","journal-title":"J Int AIDS Soc"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1097\/qai.0000000000002902","article-title":"Evaluation of SAMBA II: a qualitative and semiquantitative HIV point-of-care nucleic acid test","volume":"89","author":"Violette","year":"2022","journal-title":"J Acquir Immune Defic Syndr"},{"key":"ref19","year":"2013"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"914","DOI":"10.2471\/blt.12.102780","article-title":"Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings","volume":"90","author":"Wu","year":"2012","journal-title":"Bull World Health Organ"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"e45","DOI":"10.1097\/qai.0000000000000978","article-title":"Diagnostic accuracy of the point-of-care Xpert HIV-1 viral load assay in a South African HIV clinic","volume":"72","author":"Garrett","year":"2016","journal-title":"J Acquir Immune Defic Syndr"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1016\/j.jviromet.2015.12.007","article-title":"Comparison of the Cepheid GeneXpert and Abbott M2000 HIV-1 real time molecular assays for monitoring HIV-1 viral load and detecting HIV-1 infection","volume":"229","author":"Ceffa","year":"2016","journal-title":"J Virol Methods"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"1062","DOI":"10.1111\/j.1469-0691.2010.03279.x","article-title":"Point-of-care tests for diagnosing infections in the developing world","volume":"16","author":"Peeling","year":"2010","journal-title":"Clin Microbiol Infect"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"105127","DOI":"10.1016\/j.jcv.2022.105127","article-title":"Performance assessment of the new Xpert\u00ae HIV-1 viral load XC assay for quantification of HIV-1 viral loads","volume":"149","author":"Ehret","year":"2022","journal-title":"J Clin Virol"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"e0164346","DOI":"10.1371\/journal.pone.0164346","article-title":"Loss to follow-up from HIV screening to ART initiation in rural China","volume":"11","author":"Gu","year":"2016","journal-title":"PLoS One"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"21579","DOI":"10.7448\/ias.20.1.21579","article-title":"Clinical and public health implications of acute and early HIV detection and treatment: a scoping review","volume":"20","author":"Rutstein","year":"2017","journal-title":"J Int AIDS Soc"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"e555","DOI":"10.1016\/s2352-3018(17)30131-5","article-title":"Testing and linkage to HIV care in China: a cluster-randomised trial","volume":"4","author":"Wu","year":"2017","journal-title":"Lancet HIV"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"887","DOI":"10.1016\/s0140-6736(22)01492-1","article-title":"The clinical effect of point-of-care HIV diagnosis in infants: a systematic review and meta-analysis","volume":"400","author":"Luo","year":"2022","journal-title":"Lancet"},{"key":"ref29","year":"2019"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"e0218369","DOI":"10.1371\/journal.pone.0218369","article-title":"Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care","volume":"14","author":"Agutu","year":"2019","journal-title":"PLoS One"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"e0168244","DOI":"10.1371\/journal.pone.0168244","article-title":"Options to expand HIV viral load testing in South Africa: evaluation of the GeneXpert\u00ae HIV-1 viral load assay","volume":"11","author":"Gous","year":"2016","journal-title":"PLoS One"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"e442","DOI":"10.1016\/s2352-3018(17)30097-8","article-title":"Xpert HIV-1 point-of-care test for neonatal diagnosis of HIV in the birth testing programme of a maternity hospital: a field evaluation study","volume":"4","author":"Technau","year":"2017","journal-title":"Lancet HIV"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1093\/cid\/civ866","article-title":"Access and quality of HIV-related point-of-care diagnostic testing in global health programs","volume":"62","author":"Fonjungo","year":"2016","journal-title":"Clin Infect Dis"}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1707432\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T13:26:31Z","timestamp":1766150791000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1707432\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,19]]},"references-count":33,"alternative-id":["10.3389\/fpubh.2025.1707432"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2025.1707432","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,19]]},"article-number":"1707432"}}