Low specificity of point-of-care circulating cathodic antigen (POCCCA) diagnostic test in a non-endemic area for schistosomiasis mansoni in Brazil.

Autor: Graeff-Teixeira C; Infectious Diseases Unit (NDI), Center for Health Sciences, Universidade Federal do Espírito Santo, Vitória, ES, Brazil; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil., Favero V; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil., Pascoal VF; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil., de Souza RP; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: renata.perotto@acad.pucrs.br., Rigo FV; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil., Agnese LHD; Research Group on Biomedical Parasitology, School of Sciences, Pontíficia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil., Bezerra FSM; Department of Clinical and Toxicological Analyses, Universidade Federal do Ceará, Fortaleza, CE, Brazil., Coelho PMZ; René Rachou Institute, Fundação Oswaldo Cruz (FIOCRUZ), Belo Horizonte, MG, Brazil. Electronic address: paulo.zech@fiocruz.br., Enk MJ; Evandro Chagas Institute, Belém, PA, Brazil., Favre TC; Oswaldo Cruz Institute, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: tfavre@ioc.fiocruz.br., Katz N; René Rachou Institute, Fundação Oswaldo Cruz (FIOCRUZ), Belo Horizonte, MG, Brazil., Oliveira RR; Gonçalo Muniz Institute, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, BA, Brazil., Dos Reis MG; Gonçalo Muniz Institute, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, BA, Brazil; Faculty of Medicine of Bahia, Federal University of Bahia, Salvador, BA, Brazil; Department of Epidemiology of Microbial Diseases, School of Public Health, Yale University, New Haven, CT, United States of America. Electronic address: miter@bahia.fiocruz.br., Pieri OS; Oswaldo Cruz Institute, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: otavio.pieri@gmail.com.
Jazyk: angličtina
Zdroj: Acta tropica [Acta Trop] 2021 May; Vol. 217, pp. 105863. Date of Electronic Publication: 2021 Feb 13.
DOI: 10.1016/j.actatropica.2021.105863
Abstrakt: A point-of-care test for detecting schistosome circulating cathodic antigen in urine (POCCCA) has been proposed for mapping infection and defining prevalence thresholds for mass drug administration (MDA). However, there is increasing evidence that POCCCA may yield false-positive results, which requires rigorous specificity evaluation in non-endemic areas. POCCCA was applied in an area known to be free from infection and devoid of any condition for schistosomiasis transmission as part of a multicentre study to evaluate the performance of POCCCA in Brazil's low or potentially endemic settings. Besides POCCCA detection in urine, a search for eggs in stool was performed by Kato-Katz (KK) and Helmintex (HTX) methods. One-hundred-and-seventy-four participants returned urine samples, 140 of which delivered stool samples. All these were HTX-negative for Schistosoma mansoni, and all 118 tested with KK were negative for both S. mansoni and soil-transmitted helminths. POCCCA results from freshly collected urine yielded a specificity of 62.1% (95% CI: 53.6% - 70.2%), taking trace outcomes as positive according to the manufacturer's instructions. Retesting urine from the 140 HTX-negatives after one-year storage at -20 °C with two new POCCCA batches simultaneously yielded significantly different specificities (34.3%; 95%CI: 26.5% - 42.8% and 75.0%; 95% CI: 67.0% - 81.9%). These two batches had a weak agreement (Cohen's kappa: 0.56; 95%CI: 0.44-0.68) among the 174 urine samples retested. At present, POCCCA cannot be recommended either as a cut-off point for MDA or a reliable diagnostic tool for treatment of the infection carriers (selective chemotherapy) in low endemic areas and at final stages of transmission interruption. Manufacturers should be required to optimize production standardization and to assure quality and reproducibility of the test. Extended rigorous performance evaluations by different users from different regions are needed before POCCCA is widely recommended.
(Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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