{"doi":"10.1093/infdis/jiac289","title":"Diagnostic Performance of Loop-Mediated Isothermal Amplification and Ultrasensitive Rapid Diagnostic Tests for Malaria Screening Among Pregnant Women in Kenya","abstract":"BACKGROUND: Screen-and-treat strategies with sensitive diagnostic tests may reduce malaria-associated adverse pregnancy outcomes. We conducted a diagnostic accuracy study to evaluate new point-of-care tests to screen pregnant women for malaria at their first antenatal visit in western Kenya. METHODS: Consecutively women were tested for Plasmodium infection by expert microscopy, conventional rapid diagnostic test (cRDT), ultra sensitive RDT (usRDT), and loop-mediated isothermal amplification (LAMP). Photoinduced electron-transfer polymerase chain reaction (PET-PCR) served as the reference standard. Diagnostic performance was calculated and modelled at low parasite densities. RESULTS: Between May and September 2018, 172 of 482 screened participants (35.7%) were PET-PCR positive. Relative to PET-PCR, expert microscopy was least sensitive (40.1%; 95% confidence interval [CI], 32.7%-47.9%), followed by cRDT (49.4%; 95% CI, 41.7%-57.1), usRDT (54.7%; 95% CI, 46.9%-62.2%), and LAMP (68.6%; 95% CI, 61.1%-75.5%). Test sensitivities were comparable in febrile women (n = 90). Among afebrile women (n = 392), the geometric-mean parasite density was 29 parasites/µL and LAMP (sensitivity = 61.9%) and usRDT (43.2%) detected 1.74 (95% CI, 1.31-2.30) and 1.21 (95% CI, 88-2.21) more infections than cRDT (35.6%). Per our model, tests performed similarly at densities >200 parasites/µL. At 50 parasites/µL, the sensitivities were 45%, 56%, 62%, and 74% with expert microscopy, cRDT, usRDT, and LAMP, respectively. CONCLUSIONS: This first-generation usRDT provided moderate improvement in detecting low-density infections in afebrile pregnant women compared to cRDTs.","journal":"The Journal of Infectious Diseases","year":2022,"id":259973,"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":16,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9597,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":913739,"name":"Oliver Towett","orcid":null,"position":1,"is_corresponding":false},{"id":913059,"name":"Brian Seda","orcid":"0000-0003-4714-3140","position":2,"is_corresponding":false},{"id":348832,"name":"Ryan E. Wiegand","orcid":"0000-0002-9486-1850","position":3,"is_corresponding":false},{"id":316262,"name":"Kephas Otieno","orcid":null,"position":4,"is_corresponding":false},{"id":913740,"name":"Miriam Chomba","orcid":null,"position":5,"is_corresponding":false},{"id":249738,"name":"Naomi W. Lucchi","orcid":"0000-0001-8789-8041","position":6,"is_corresponding":false},{"id":913741,"name":"Dragan Ljolje","orcid":null,"position":7,"is_corresponding":false},{"id":913742,"name":"Kammerle Schneider","orcid":null,"position":8,"is_corresponding":false},{"id":775180,"name":"Patrick Walker","orcid":"0000-0002-9596-9628","position":9,"is_corresponding":false},{"id":315419,"name":"Titus K. Kwambai","orcid":"0000-0003-1930-0911","position":10,"is_corresponding":false},{"id":349726,"name":"Laurence Slutsker","orcid":null,"position":11,"is_corresponding":false},{"id":315430,"name":"Feiko O. ter Kuile","orcid":"0000-0003-3663-5617","position":12,"is_corresponding":false},{"id":315423,"name":"Simon Kariuki","orcid":"0000-0003-0554-1976","position":13,"is_corresponding":false},{"id":315424,"name":"Aaron M. Samuels","orcid":"0000-0002-8355-8186","position":0,"is_corresponding":true}],"reference_count":31,"raw_metadata":null,"created_at":"2026-07-19T00:26:03.189798Z","pmid":"35811308","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":[]}