{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T10:16:21Z","timestamp":1788171381540,"version":"build-2803163510"},"reference-count":23,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Early and accurate quantification of Human Immunodeficiency Virus type 1 (HIV-1) viral load is essential for monitoring antiretroviral therapy and guiding clinical management. Although conventional real-time polymerase chain reaction (PCR) platforms provide reliable viral load measurement, they often require centralized laboratories and longer turnaround times. Cartridge-based systems such as the GeneXpert HIV-1 Viral Load assay offer a simplified testing workflow and may facilitate decentralized molecular testing. This study aimed to evaluate the qualitative and quantitative agreement between the GeneXpert HIV-1 Viral Load assay and the Abbott Alinity m HIV-1 assay. Methods: A total of 102 residual clinical Ethylenediaminetetraacetic acid (EDTA) plasma specimens were analyzed using both the GeneXpert HIV-1 Viral Load assay and the Abbott Alinity m HIV-1 assay. Qualitative agreement was evaluated using positive percent agreement (PPA), negative percent agreement (NPA), overall agreement, and Cohen\u2019s \u03ba coefficient. Quantitative agreement among specimens with paired quantifiable viral load results was assessed using Pearson\u2019s correlation and Bland\u2013Altman analyses. Results: Overall qualitative agreement between the two assays was 95.1%, with a PPA of 92.6%, an NPA of 100.0%, and a Cohen\u2019s \u03ba coefficient of 0.894, indicating almost perfect agreement. Among the 57 specimens with paired quantifiable viral load results, a very strong positive correlation was observed (Pearson\u2019s r = 0.9972; 95% CI: 0.9952\u20130.9984; p &lt; 0.001). Bland\u2013Altman analysis demonstrated a minimal mean bias of \u22120.018 log10 IU\/mL, with 95% limits of agreement ranging from \u22120.175 to 0.139 log10 International Units per milliliter (IU\/mL). All paired quantitative differences were within the clinically accepted agreement threshold of \u00b10.5 log10 IU\/mL. Conclusions: The GeneXpert HIV-1 Viral Load assay demonstrated excellent qualitative and quantitative agreement with the Abbott Alinity m HIV-1 assay. These findings support the potential use of the GeneXpert HIV-1 Viral Load assay as an alternative testing platform for routine HIV-1 viral load monitoring in appropriate clinical settings.<\/jats:p>","DOI":"10.3390\/diagnostics16172795","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T09:21:19Z","timestamp":1788168079000},"page":"2795","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical Agreement of the GeneXpert HIV-1 Viral Load Assay Compared with the Abbott Alinity m HIV-1 Assay"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-3980-1177","authenticated-orcid":false,"given":"Khulud A.","family":"Alhazmi","sequence":"first","affiliation":[{"name":"Department of Microbiology and Parasitology, Faculty of Medicine, Umm Al-Qura University, Makkah 24382, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1693-2093","authenticated-orcid":false,"given":"Sulaiman","family":"Bani AbdelRahman","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Pathology, Faculty of Medicine, Mutah University, P.O. Box 7, Mutah, Al-Karak 61710, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hala","family":"Altarawneh","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Pathology, Faculty of Medicine, Mutah University, P.O. Box 7, Mutah, Al-Karak 61710, Jordan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karem","family":"Ibrahem","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Department of Clinical Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6198-5566","authenticated-orcid":false,"given":"Waiel S.","family":"Halabi","sequence":"additional","affiliation":[{"name":"Department of Optometry, Faculty of Applied Medical Sciences, University of Jeddah, Jeddah 23218, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4435-6274","authenticated-orcid":false,"given":"Abdulaziz","family":"Alsaedi","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Department of Clinical Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1142-6846","authenticated-orcid":false,"given":"Turki","family":"Asiri","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Parasitology, Faculty of Medicine, King Abdulaziz University, Rabigh 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3205-2986","authenticated-orcid":false,"given":"Bandar Hasan","family":"Saleh","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Department of Clinical Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6834-2379","authenticated-orcid":false,"given":"Mohammed","family":"Mufrrih","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Special Infectious Agents Unit BSL-3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9512-1985","authenticated-orcid":false,"given":"Ahmad M.","family":"Alharbi","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khalid J.","family":"Shrwani","sequence":"additional","affiliation":[{"name":"Department of Medical Virology, Public Health Laboratory, Public Health Authority, P.O. Box 716, Jazan 45142, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2134-6695","authenticated-orcid":false,"given":"Radi","family":"Alsafi","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Sciences, Faculty of Applied Medical Sciences, Umm Al-Qura University, Makkah 24381, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulelah","family":"Aljuaid","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0354-1113","authenticated-orcid":false,"given":"Mohannad A.","family":"Alzain","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Family Medicine and Chronic Diseases Research Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mona Abdulrahman","family":"Alqarni","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4449-3372","authenticated-orcid":false,"given":"Nojoud","family":"Faqerah","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Parasitology, Faculty of Medicine, King Abdulaziz University, Rabigh 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0848-5465","authenticated-orcid":false,"given":"Rawan","family":"Altalhi","sequence":"additional","affiliation":[{"name":"Department of Biological Sciences, College of Science, University of Jeddah, Jeddah 23445, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hatoon A.","family":"Niyazi","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Department of Clinical Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noha A.","family":"Juma","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noura","family":"Daffa","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6684-1887","authenticated-orcid":false,"given":"Nariman","family":"Sindi","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5322-0953","authenticated-orcid":false,"given":"Wafaa","family":"Alhazmi","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8519-2619","authenticated-orcid":false,"given":"Ala A.","family":"Azhari","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology and Immunology, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"},{"name":"Vaccines and Immunotherapy Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-9964-2472","authenticated-orcid":false,"given":"Basem A.","family":"Jawa","sequence":"additional","affiliation":[{"name":"Laboratory and Blood Bank, Alnoor Specialist Hospital, Makkah Health Cluster, Makkah 24241, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1128\/CMR.00064-18","article-title":"Diagnosis of human immunodeficiency virus infection","volume":"32","author":"Parekh","year":"2018","journal-title":"Clin. 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