{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T13:59:59Z","timestamp":1790171999811,"version":"4.1.0"},"reference-count":16,"publisher":"American Society for Microbiology","license":[{"start":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T00:00:00Z","timestamp":1790121600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T00:00:00Z","timestamp":1790121600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["U01PS005204-01-00"],"award-info":[{"award-number":["U01PS005204-01-00"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Current diagnostic algorithms for HIV-1 primarily depend on antigen-antibody tests, with nucleic acid tests reserved for confirmation and monitoring of antiretroviral therapy. Incorporating a quantitative nucleic acid test at the point of care could provide faster diagnosis and viral load measurement in a single clinical encounter, expediting linkage to care. This study evaluates the Xpert HIV-1 Viral Load XC (Xpert VL XC) assay as a candidate for primary nucleic acid testing use within HIV-1 diagnostic workflows, compared to standard-of-care approaches. The Xpert VL XC demonstrated a measurable analytical range of 60\u20131 \u00d7 10\n                      <jats:sup>6<\/jats:sup>\n                      copies\/mL (\n                      <jats:italic toggle=\"yes\">R<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      = 0.99) with 100% detection across tested concentrations. Precision analyses showed greatest variability at the lowest concentration, with acceptable assay reproducibility. Agreement analyses using 20 HIV-1 positive and 10 HIV-1 negative plasma samples showed 100% agreement compared to the Roche cobas HIV-1 (quantitative) assay. The Xpert VL XC was compared to four other HIV assays, including the Xpert HIV-1 Qual XC. The Xpert VL XC produced 3.2% invalid results and achieved negative agreement of \u226596.8%. Positive agreement ranged from 80.8% to 90.0%, with most discrepancies occurring below the 40 copies\/mL lower limit of quantification threshold. The Xpert HIV-1 Qual XC was the only assay that detected all 26 samples that were positive using the standard immunoassay diagnostic algorithm. Average turnaround time was 3 h, faster than the 21 h average for conventional batch testing. These findings highlight the limitations of implementing rapid molecular HIV-1 diagnostics and the need for both sensitive and rapid approaches.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>Current testing algorithms for the diagnosis of HIV-1 initially test samples with an antigen\/antibody test followed by an antibody differentiation test if the screening test is positive. Nucleic acid tests are used to aid in the diagnosis (qualitative and quantitative assays) or monitoring a patient\u2019s response to antiretroviral therapy (quantitative). However, a quantitative diagnostic nucleic acid test may have additional utility, particularly in point-of-care settings, or near the patient care site. This would allow both diagnosis and initial viral load measurement to occur during a single visit, permitting rapid linkage to care. We evaluated the Xpert HIV-1 Viral Load XC test as a potential tool for primary nucleic acid testing within the HIV-1 diagnostic algorithm and assessed its suitability for use under the unique constraints of point-of-care environments.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.02646-26","type":"journal-article","created":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T13:03:56Z","timestamp":1790168636000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Validation and performance of a rapid HIV-1 viral load assay"],"prefix":"10.1128","author":[{"given":"Katharine","family":"Uhteg","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05cb1k848","id-type":"ROR","asserted-by":"publisher"}],"name":"Johns Hopkins Hospital Medical Microbiology Laboratory","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad H.","family":"Bayan","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alec","family":"Boudreau","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoe O.","family":"Demko","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin J.","family":"MacGowan","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00qzjvm58","id-type":"ROR","asserted-by":"publisher"}],"name":"Centers for Disease Control and Prevention","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin P.","family":"Delaney","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00qzjvm58","id-type":"ROR","asserted-by":"publisher"}],"name":"Centers for Disease Control and Prevention","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8619-5598","authenticated-orcid":false,"given":"Yukari C.","family":"Manabe","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1277-819X","authenticated-orcid":false,"given":"Matthew M.","family":"Hamill","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0274-8966","authenticated-orcid":true,"given":"Heba H.","family":"Mostafa","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05cb1k848","id-type":"ROR","asserted-by":"publisher"}],"name":"Johns Hopkins Hospital Medical Microbiology Laboratory","place":["Baltimore, USA"]},{"name":"Division of Medical Microbiology, Department of Pathology, Johns Hopkins School of Medicine","place":["Baltimore, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","published-online":{"date-parts":[[2026,9,23]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"Centers for Disease Control and Prevention. 2026. CDC publishes 2024 national HIV data. National Center for HIV Viral Hepatitis STD and Tuberculosis Prevention (NCHHSTP). Available from: https:\/\/www.cdc.gov\/nchhstp\/whats-new\/2024-hiv-surveillance-data.html"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6903a2"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr7401a1"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiab152"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013208.pub2"},{"key":"e_1_3_4_7_2","unstructured":"U.S. Food and Drug Administration. 2026. Complete list of donor screening assays for infectious agents and HIV diagnostic assays. Available from: https:\/\/www.fda.gov\/vaccines-blood-biologics\/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-023-08459-7"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.48380"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01673-17"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2016.04.014"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001003"},{"key":"e_1_3_4_13_2","article-title":"Performance comparison of Xpert HIV-1 viral load assay and Roche Taqman and Abbott M2000 RT in Bamako, Mali","volume":"11","author":"Kone B","year":"2020","unstructured":"Kone B, Goita D, Dolo O, Traore D, Sogoba D, Somboro A, Sanogo M, Somboro AM, Coulibaly N, Sanogo A, et al.. 2020. Performance comparison of Xpert HIV-1 viral load assay and Roche Taqman and Abbott M2000 RT in Bamako, Mali. J AIDS Clin Res 11:46953.","journal-title":"J AIDS Clin Res"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2019.104214"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000865"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.4819"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000001083"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02646-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02646-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T13:03:58Z","timestamp":1790168638000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.02646-26"}},"subtitle":[],"editor":[{"given":"J. J.","family":"Miranda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,9,23]]},"references-count":16,"alternative-id":["10.1128\/spectrum.02646-26"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.02646-26","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,23]]},"assertion":[{"value":"2026-08-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e02646-26"}}