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

• Published in: Acta tropica Vol. 217; p. 105863
• Main Authors: Graeff-Teixeira, Carlos, Favero, Vivian, Pascoal, Vanessa Fey, de Souza, Renata Perotto, Rigo, Francine de Vargas, Agnese, Luize Hoffmann Dall, Bezerra, Fernando Schemelzer Moraes, Coelho, Paulo Marcos Zech, Enk, Martin Johannes, Favre, Tereza Cristina, Katz, Naftale, Oliveira, Ricardo Riccio, dos Reis, Mitermayer Galvão, Pieri, Otavio Sarmento
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.05.2021
• Subjects: antigens; Brazil; Circulating cathodic antigen (POC-CCA); diagnostic techniques; drug therapy; drugs; Helmintex; helminths; Kato-Katz; point-of-care systems; Schistosoma mansoni; Schistosoma mansoni; schistosomiasis mansoni; urine; Brazil; Brazil; Kato-Katz; Circulating cathodic antigen (POC-CCA); Schistosoma mansoni; Helmintex
• ISSN: 0001-706X; 1873-6254; 1873-6254
• DOI: 10.1016/j.actatropica.2021.105863

[Display omitted] 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.