{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T16:53:49Z","timestamp":1785430429890,"version":"3.56.0"},"reference-count":68,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T00:00:00Z","timestamp":1780963200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008982","name":"Qatar national research fund","doi-asserted-by":"publisher","award":["UREP30-041-3-014"],"award-info":[{"award-number":["UREP30-041-3-014"]}],"id":[{"id":"10.13039\/100008982","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008982","name":"Qatar national research fund","doi-asserted-by":"publisher","award":["GSRA8-L-1-0501-21022"],"award-info":[{"award-number":["GSRA8-L-1-0501-21022"]}],"id":[{"id":"10.13039\/100008982","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008982","name":"Qatar national research fund","doi-asserted-by":"publisher","award":["NPRP13S-0128-200185"],"award-info":[{"award-number":["NPRP13S-0128-200185"]}],"id":[{"id":"10.13039\/100008982","id-type":"DOI","asserted-by":"publisher"}]},{"award":["UREP30-041-3-014"],"award-info":[{"award-number":["UREP30-041-3-014"]}],"id":[{"id":"https:\/\/ror.org\/01svaqq28","id-type":"ROR","asserted-by":"publisher"}]},{"award":["GSRA8-L-1-0501-21022"],"award-info":[{"award-number":["GSRA8-L-1-0501-21022"]}],"id":[{"id":"https:\/\/ror.org\/01svaqq28","id-type":"ROR","asserted-by":"publisher"}]},{"award":["NPRP13S-0128-200185"],"award-info":[{"award-number":["NPRP13S-0128-200185"]}],"id":[{"id":"https:\/\/ror.org\/01svaqq28","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Microorganisms"],"abstract":"<jats:p>Fourth-generation immunoassays are widely used for HIV and syphilis screening; however, false-reactive results may increase confirmatory testing and operational burden in high-throughput laboratories. This study evaluated the comparative performance of automated chemiluminescent immunoassays (MAGLUMI\u00ae HIV Ab\/Ag Combi (Snibe Diagnostics Co. Ltd., Shenzhen, China), VITROS\u00ae ECiQ HIV Combo (Ortho Clinical Diagnostics, Raritan, NJ, USA), MAGLUMI\u00ae Syphilis (Snibe Diagnostics Co. Ltd., Shenzhen, China), and ARCHITECT\u00ae Syphilis TP (Abbott Diagnostics, Abbott Park, IL, USA) within a routine diagnostic algorithm, incorporating antibody differentiation immunoassays (INNO-LIA\u00ae HIV I\/II Score (Fujirebio Europe N.V., Ghent, Belgium) and HIV-1 RNA PCR where applicable. A total of 240 archived serum samples for HIV testing and 180 for syphilis testing were analyzed. Agreement-based performance measures including sensitivity, specificity, overall percent agreement (OPA), and Cohen\u2019s kappa (\u03ba) were calculated as comparator-based estimates reflecting concordance within the routine diagnostic algorithm rather than absolute diagnostic accuracy against a universal reference standard. For comparisons with HIV-1 RNA PCR, positive and negative concordance rates are reported to reflect agreement between assays detecting different biological targets. Among samples with definitive (positive or negative) results, the MAGLUMI\u00ae HIV Ab\/Ag Combi assay showed complete agreement with INNO-LIA\u00ae HIV I\/II Score (\u03ba = 1.00) and high agreement with PCR within the ARCHITECT\u00ae HIV Ag\/Ab Combo-reactive subset (\u03ba = 0.90). The VITROS\u00ae ECiQ HIV Combo assay demonstrated high agreement with INNO-LIA\u00ae HIV I\/II Score (\u03ba = 0.916) and substantial agreement with PCR (\u03ba = 0.715), with a lower negative concordance rate with PCR observed in the ARCHITECT-reactive subset. A parallel five-modality analysis of 11 discordant samples applying the CDC 2014 algorithm demonstrated that all three immunoassay platforms successfully detected confirmed HIV-seropositive individuals with controlled viremia despite negative PCR, while MAGLUMI\u00ae HIV Ab\/Ag Combi produced fewer false-reactive results than both ARCHITECT\u00ae and VITROS\u00ae in this discordant subset. Additionally, two cases showed INNO-LIA\u00ae indeterminate results with positive PCR, consistent with acute HIV infection during the early seroconversion stage; all three immunoassay platforms produced signals above the non-reactive threshold in both cases. For syphilis testing, both MAGLUMI\u00ae Syphilis and ARCHITECT\u00ae Syphilis TP assays showed complete agreement with INNO-LIA\u00ae Syphilis Score among samples with definitive results (\u03ba = 1.00). In contrast, the RPR assay showed reduced positive predictive value (49.4%) and moderate agreement with INNO-LIA\u00ae Syphilis Score (\u03ba = 0.52). Automated chemiluminescent immunoassay (CLIA) platforms demonstrated high agreement within a structured diagnostic algorithm in a high-throughput screening setting. Differences in assay performance were observed across platforms, particularly with respect to discordant results in the ARCHITECT-reactive PCR-evaluated subset for HIV and non-treponemal concordance for syphilis. These platforms may support more efficient laboratory workflows; however, findings should be interpreted within the context of comparator-based classification rather than absolute diagnostic accuracy.<\/jats:p>","DOI":"10.3390\/microorganisms14061302","type":"journal-article","created":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T00:58:12Z","timestamp":1781053092000},"page":"1302","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Strengthening STD Screening Programs: Comprehensive Evaluation of High-Throughput Immunoassays for HIV and Syphilis Detection"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0102-8155","authenticated-orcid":false,"given":"Ahmed","family":"Ismail","sequence":"first","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaden","family":"Abunasser","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar"},{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israa M.","family":"Salameh","sequence":"additional","affiliation":[{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mazen Najib","family":"Abouassali","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manal","family":"Elshaikh","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim Wissam","family":"Karimeh","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed Abdelfatah","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mutaz Mohamed","family":"Ali","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim Al","family":"Shaar","sequence":"additional","affiliation":[{"name":"Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parveen Banu","family":"Nizamuddin","sequence":"additional","affiliation":[{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salma","family":"Younes","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar"},{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadi M.","family":"Yassine","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar"},{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0790-0506","authenticated-orcid":false,"given":"Laith J.","family":"Abu-Raddad","sequence":"additional","affiliation":[{"name":"Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation\u2014Education City, Doha 24144, Qatar"},{"name":"World Health Organization Collaborating Centre for Disease Epidemiology Analytics on HIV\/AIDS, Sexually Transmitted Infections, and Viral Hepatitis, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation-Education City, Doha 24144, Qatar"},{"name":"Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY 10065, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5241-944X","authenticated-orcid":false,"given":"Nadin","family":"Younes","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar"},{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9252-1038","authenticated-orcid":false,"given":"Gheyath K.","family":"Nasrallah","sequence":"additional","affiliation":[{"name":"Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar"},{"name":"Biomedical Research Center, Qatar University, Doha 2713, Qatar"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1016\/j.pop.2013.05.001","article-title":"Sexually transmitted diseases","volume":"40","author":"Markle","year":"2013","journal-title":"Prim. 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