{"doi":"10.1093/cid/ciaa986","title":"The Immunoglobulin M-Shed Acute Phase Antigen (SAPA)-test for the Early Diagnosis of Congenital Chagas Disease in the Time of the Elimination Goal of Mother-to-Child Transmission","abstract":"BACKGROUND: Diagnosis of congenital Chagas disease (CChD) in most endemic areas is based on low-sensitive microscopy at birth and 9-month immunoglobulin G (IgG), which has poor adherence. We aim to evaluate the accuracy of the Immunoglobulin M (IgM)-Shed Acute Phase Antigen (SAPA) test in the diagnosis of CChD at birth. METHODS: Two cohort studies (training and validation cohorts) were conducted in 3 hospitals in the department of Santa Cruz, Bolivia. Pregnant women were screened for Chagas disease, and all infants born to seropositive mothers were followed for up to 9 months to diagnose CChD. A composite reference standard was used to determine congenital infection and was based on the parallel use of microscopy, quantitative polymerase chain reaction (qPCR), and IgM-trypomastigote excreted-secreted antigen (TESA) blot at birth and/or 1 month, and/or the detection of anti-Trypanosoma cruzi IgG at 6 or 9 months. The diagnostic accuracy of the IgM-SAPA test was calculated at birth against the composite reference standard. RESULTS: Adherence to the 6- or 9-month follow-up ranged from 25.3% to 59.7%. Most cases of CChD (training and validation cohort: 76.5% and 83.7%, respectively) were detected during the first month of life using the combination of microscopy, qPCR, and/or IgM-TESA blot. Results from the validation cohort showed that when only 1 infant sample obtained at birth was evaluated, the qPCR and the IgM-SAPA test have similar accuracy (sensitivity: range, 79.1%-97.1% and 76.7%-94.3%, respectively, and specificity: 99.5% and 92.6%, respectively). CONCLUSIONS: The IgM-SAPA test has the potential to be implemented as an early diagnostic tool in areas that currently rely only on microscopy.","journal":"Clinical Infectious Diseases","year":2020,"id":88325,"datarank":0.3596842909197557,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"self_citation_contribution":0.3596842909197557,"citation_network_contribution":0.0,"self_endowment_contribution":0.3596842909197557,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9397,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":379298,"name":"Freddy Tinajeros","orcid":"0000-0002-5894-2637","position":1,"is_corresponding":false},{"id":235422,"name":"Caryn Bern","orcid":"0000-0001-8195-7303","position":2,"is_corresponding":false},{"id":448517,"name":"Gerson Galdos‐Cardenas","orcid":null,"position":3,"is_corresponding":false},{"id":379299,"name":"Edith Málaga","orcid":"0000-0002-0075-6655","position":4,"is_corresponding":false},{"id":447680,"name":"Edward Valencia Ayala","orcid":"0000-0002-5318-5526","position":5,"is_corresponding":false},{"id":448518,"name":"Kathryn A. Hjerrild","orcid":null,"position":6,"is_corresponding":false},{"id":432910,"name":"Steven J. Clipman","orcid":"0000-0002-2366-8420","position":7,"is_corresponding":false},{"id":336848,"name":"Andrés G. Lescano","orcid":"0000-0001-9779-633X","position":8,"is_corresponding":false},{"id":448519,"name":"Tabitha Bayangos","orcid":null,"position":9,"is_corresponding":false},{"id":447681,"name":"Walter Castillo-Urquiaga","orcid":"0000-0002-1054-7398","position":10,"is_corresponding":false},{"id":448520,"name":"María Carmen Menduiña","orcid":null,"position":11,"is_corresponding":false},{"id":323515,"name":"Kawsar R. Talaat","orcid":"0000-0002-4899-6260","position":12,"is_corresponding":false},{"id":304253,"name":"Robert H. Gilman","orcid":"0000-0002-9037-0712","position":13,"is_corresponding":false},{"id":448521,"name":"Chagas Working Group in Bolivia and Peru","orcid":null,"position":14,"is_corresponding":false},{"id":447679,"name":"Yagahira E. Castro-Sesquen","orcid":"0000-0001-6824-9206","position":0,"is_corresponding":true}],"reference_count":33,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T22:00:56.736935Z","pmid":"32667981","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":[]}