{"doi":"10.1128/spectrum.00307-24","title":"Evaluation of Xpert point-of-care assays for detection of HIV infection in persons using long-acting cabotegravir for pre-exposure prophylaxis","abstract":"Detection of HIV infection may be challenging in persons using long-acting cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) due to viral suppression and reduced/delayed antibody production. We evaluated two point-of-care tests for detecting HIV infection in persons who received CAB-LA in the HPTN 083 trial. Samples were obtained from 12 participants who received CAB-LA and had delayed detection of HIV infection using HIV rapid tests and an antigen/antibody test (52 plasma samples; 18 dried blood spot [DBS] samples). Plasma samples were tested with the Xpert HIV-1 Viral Load XC test (Xpert VL-XC); DBS samples were tested with the total nucleic acid Xpert HIV-1 Qual XC test (Xpert Qual-XC). Results from these assays were compared to results from three reference, laboratory-based, plasma RNA assays (Aptima HIV-1 Qualitative assay [Aptima Qual]; Aptima HIV-1 Quant DX Assay [Aptima Quant]; cobas HIV-1/HIV-2 Qualitative Test [cobas]). HIV RNA was detected with all four plasma assays for all samples with viral loads (VLs) ≥ 200 copies/mL; the number of samples with VLs < 200 copies/mL with HIV RNA detected was: Xpert VL-XC: 19/26 (73.1%); Aptima Qual: 17/26 (65.4%); Aptima Quant: 17/26 (65.4%); and cobas: 12/21 (57.1%). The Xpert Qual-XC assay was positive for all DBS samples with VLs ≥ 200 copies/mL and 1/10 DBS with VLs < 200 copies/mL. The performance of the Xpert VL-XC assay was comparable to the reference assays for detecting HIV infection in these cases. The Xpert Qual-XC assay was less sensitive than plasma-based HIV RNA assays for detecting HIV in the setting of CAB-LA PrEP. IMPORTANCE: HIV RNA assays can detect HIV infections earlier than HIV rapid tests or Ag/Ab tests in persons using CAB-LA PrEP. Earlier HIV diagnosis could allow for earlier treatment initiation and reduced risk of INSTI resistance. POC tests may help detect HIV infection before CAB-LA administration and may be more accessible than laboratory-based assays in some settings. In this study, the POC Xpert VL-XC assay detected HIV RNA in most samples from individuals who received CAB-LA PrEP and had delayed detection of HIV infection with HIV rapid tests and an Ag/Ab test. The performance of this assay was similar to laboratory-based HIV RNA assays in this cohort. The POC Xpert Qual-XC assay detects both HIV RNA and DNA, with a higher viral load cutoff for RNA detection. This assay was negative for most lower viral load samples and did not offer an advantage for HIV screening in persons using CAB-LA PrEP.","journal":"Microbiology Spectrum","year":2024,"id":440724,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":9,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9488,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":840610,"name":"Estelle Piwowar-Manning","orcid":null,"position":1,"is_corresponding":false},{"id":1045670,"name":"Amber Moser","orcid":null,"position":2,"is_corresponding":false},{"id":1253181,"name":"Tinia Hill","orcid":null,"position":3,"is_corresponding":false},{"id":630565,"name":"Shahnaz Ahmed","orcid":"0000-0002-5197-4249","position":4,"is_corresponding":false},{"id":443217,"name":"Vanessa Cummings","orcid":"0000-0001-7325-1837","position":5,"is_corresponding":false},{"id":251887,"name":"Heba H. Mostafa","orcid":"0000-0002-0274-8966","position":6,"is_corresponding":false},{"id":572934,"name":"Zhe Wang","orcid":"0000-0003-4102-1353","position":7,"is_corresponding":false},{"id":616708,"name":"Andrea Jennings","orcid":null,"position":8,"is_corresponding":false},{"id":614921,"name":"Jorge A. Gallardo-Cartagena","orcid":"0000-0001-5142-1954","position":9,"is_corresponding":false},{"id":535825,"name":"María Inés Figueroa","orcid":null,"position":10,"is_corresponding":false},{"id":630566,"name":"Marty St. Clair","orcid":"0000-0002-2221-2181","position":11,"is_corresponding":false},{"id":357404,"name":"Alex R. Rinehart","orcid":null,"position":12,"is_corresponding":false},{"id":374738,"name":"Adeola Adeyeye","orcid":"0000-0002-3677-6068","position":13,"is_corresponding":false},{"id":255291,"name":"James F. Rooney","orcid":"0000-0003-3261-0711","position":14,"is_corresponding":false},{"id":249712,"name":"Myron S. Cohen","orcid":"0000-0001-5917-9664","position":15,"is_corresponding":false},{"id":314047,"name":"Beatriz Grinsztejn","orcid":"0000-0003-3692-5155","position":16,"is_corresponding":false},{"id":396975,"name":"Raphael J. Landovitz","orcid":"0000-0002-1442-714X","position":17,"is_corresponding":false},{"id":36851,"name":"Susan H. Eshleman","orcid":"0000-0002-4587-791X","position":18,"is_corresponding":false},{"id":1253182,"name":"On behalf of the HPTN 083 Study Team","orcid":null,"position":19,"is_corresponding":false},{"id":432556,"name":"Jessica M. Fogel","orcid":"0000-0003-3143-9000","position":0,"is_corresponding":true}],"reference_count":11,"raw_metadata":null,"created_at":"2026-07-19T02:01:01.842286Z","pmid":"38980027","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}