{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T07:18:37Z","timestamp":1780730317269,"version":"3.54.1"},"reference-count":34,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,6,28]],"date-time":"2025-06-28T00:00:00Z","timestamp":1751068800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third\u2010generation antibody rapid diagnostic tests (RDTs). The current fourth\u2010generation antibody\/antigen RDT, Determine\u2122 HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine\u2122 HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger\u2010prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL &gt;10,000 copies\/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies\/ml) and 10,000 copies\/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One thousand one hundred and sixty\u2010three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10\/1124). The sensitivity of Determine\u2122 HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3\u201392.7) and to detect AHI was 20% (95% CI 2.5\u201355.6%); the specificity was equally high for both 99.8% (95% CI 99.4\u2013100).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The low sensitivity of Determine\u2122 HIV Early Detect to detect AHI when performed at the point of care using finger\u2010prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.26517","type":"journal-article","created":{"date-parts":[[2025,6,28]],"date-time":"2025-06-28T03:03:49Z","timestamp":1751079829000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Low sensitivity of the fourth\u2010generation antigen\/antibody HIV rapid diagnostic test Determine\u2122 HIV Early Detect for detection of acute HIV infection at the point of care in rural Eswatini: a diagnostic accuracy study"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0406-5218","authenticated-orcid":false,"given":"Iza","family":"Ciglenecki","sequence":"first","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Geneva Switzerland"},{"name":"Institute of Global Health University of Geneva  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nombuso","family":"Ntshalintshali","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8037-7873","authenticated-orcid":false,"given":"Esther","family":"Mukooza","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Skinner","family":"Lekelem","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mpumelelo","family":"Mavimbela","sequence":"additional","affiliation":[{"name":"Eswatini National AIDS Programme (ENAP), Ministry of Health  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sindisiwe","family":"Dlamini","sequence":"additional","affiliation":[{"name":"National Reference Laboratory (NRL) Ministry of Health  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lenhle","family":"Dube","sequence":"additional","affiliation":[{"name":"Eswatini National AIDS Programme (ENAP), Ministry of Health  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nomvuyo","family":"Mabuza","sequence":"additional","affiliation":[{"name":"National Reference Laboratory (NRL) Ministry of Health  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melat","family":"Haile","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Ellman","sequence":"additional","affiliation":[{"name":"Southern Africa Medical Unit (SAMU) M\u00e9decins Sans Fronti\u00e8res  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Flores","sequence":"additional","affiliation":[{"name":"Southern Africa Medical Unit (SAMU) M\u00e9decins Sans Fronti\u00e8res  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Keiser","sequence":"additional","affiliation":[{"name":"Institute of Global Health University of Geneva  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sindy","family":"Matse","sequence":"additional","affiliation":[{"name":"Eswatini National AIDS Programme (ENAP), Ministry of Health  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"de la Tour","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1137-6826","authenticated-orcid":false,"given":"Alexandra","family":"Calmy","sequence":"additional","affiliation":[{"name":"Institute of Global Health University of Geneva  Geneva Switzerland"},{"name":"University Hospital of Geneva  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0525-7262","authenticated-orcid":false,"given":"Bernhard","family":"Kerschberger","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res (MSF)  Mbabane Eswatini"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,28]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.1.21579"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1086\/429411"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.1.21708"},{"key":"e_1_2_11_5_1","unstructured":"PQDx_0243\u2010013\u201000DetermineHIVEarlyDetect_v8.pdf [Internet]. [cited 2024 Nov 5]. Available from:https:\/\/extranet.who.int\/prequal\/sites\/default\/files\/whopr_files\/PQDx_0243\u2010013\u201000DetermineHIVEarlyDetect_v8.pdf"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.21767\/2386-5180.100022"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2017.03.019"},{"issue":"3","key":"e_1_2_11_8_1","first-page":"382","article-title":"Assessment of HIV screening tests for use in preexposure prophylaxis programs","volume":"216","author":"Delaugerre C","year":"2017","journal-title":"J Infect Dis"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-019-00655-0"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.70044"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-052818"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2017.06.006"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2015-052491"},{"key":"e_1_2_11_14_1","article-title":"Ability of AlereTM HIV Combo to diagnose acute HIV infection is based mainly on HIV\u20101 p24 antigen detection","volume":"10","author":"Sirivichayakul","year":"2021","journal-title":"Asian Pac J Allergy Immunol"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000002794"},{"key":"e_1_2_11_16_1","unstructured":"Government of the Kingdom of Eswatini.Swaziland HIV Incidence Measurement Survey 2 (SHIMS2) 2016\u20132017.Mbabane:Government of the Kingdom of Eswatini;2019."},{"key":"e_1_2_11_17_1","unstructured":"2024 Global AIDS Report \u2014 The Urgency of Now: AIDS at a Crossroads [Internet]. [cited 2024 Oct 6]. Available from:https:\/\/www.unaids.org\/en\/resources\/documents\/2024\/global\u2010aids\u2010update\u20102024"},{"key":"e_1_2_11_18_1","volume-title":"Diagnosis and management of acute HIV infection","author":"Cowan EA","year":"2021"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000002794"},{"key":"e_1_2_11_20_1","unstructured":"Public Report for Determine HIV Early Detect (PQDx 0243\u2010013\u201000) | WHO\u2014Prequalification of Medical Products (IVDs Medicines Vaccines and Immunization Devices Vector Control) [Internet]. [cited 2024 Nov 5]. Available from:https:\/\/extranet.who.int\/prequal\/WHOPR\/public\u2010report\u2010determine\u2010hiv\u2010early\u2010detect\u2010pqdx\u20100243\u2010013\u201000"},{"key":"e_1_2_11_21_1","doi-asserted-by":"crossref","unstructured":"IrwantoI KawiNH LuisH SihotangEP JanuragaPP OktavianiM et\u00a0al.Implementing a clinical pathway for diagnosing and treating acute HIV infection among key populations attending sexual health clinics in Indonesia: cohort profile of the INTERACT study [Internet].2024[cited 2024 Nov 28]. Available from:https:\/\/www.medrxiv.org\/content\/10.1101\/2024.06.06.24307250v1","DOI":"10.1101\/2024.06.06.24307250"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics7010013"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1386-6532(01)00183-4"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jis617"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200309050-00005"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001982"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0011581"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.16.187468"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.19-0144"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-199612000-00002"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000534"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001134"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25419"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-024-09206-2"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0255065"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.26517","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,26]],"date-time":"2025-07-26T03:41:10Z","timestamp":1753501270000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jia2.26517"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,28]]},"references-count":34,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,7]]}},"alternative-id":["10.1002\/jia2.26517"],"URL":"https:\/\/doi.org\/10.1002\/jia2.26517","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"value":"1758-2652","type":"print"},{"value":"1758-2652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,28]]},"assertion":[{"value":"2025-01-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e26517"}}