{"title":"巴拉圭农村地区恰加斯病血清学检测的质量保证。","authors":"","doi":"10.1016/j.actatropica.2024.107382","DOIUrl":null,"url":null,"abstract":"<div><p>The diagnosis of Chagas disease mostly relies on the use of multiple serologic tests that are often unavailable in many of the remote settings where the disease is highly prevalent. In the Teniente Irala Fernández Municipality, in central Paraguay, efforts have been made to increase the diagnostic capabilities of specific rural health centres, but no quality assurance of the results produced has been performed. We comparatively analysed the results obtained with 300 samples tested using a commercial rapid diagnostic test (RDT) and enzyme linked immunosorbent assays (ELISA) at the laboratory of the Teniente Irala Fernández Health Center (<em>CSTIF</em>) with those generated upon repeating the tests at an independent well-equipped research laboratory (<em>CEDIC</em>). A subgroup of 52 samples were further tested at Paraguay's Central Public Health Laboratory (<em>LCSP</em>) by means of a different technique to evaluate the diagnostic performance of the tests carried out at <em>CSTIF</em>. We observed an excellent agreement between the ELISA results obtained at <em>CSTIF</em> and <em>CEDIC</em> (kappa coefficients between 0.85 and 0.93 for every kit evaluated), and an overall good performance of the tests carried out at <em>CSTIF</em>. However, the sensitivity of one kit was lower at <em>CSTIF</em> (81.3 %) than at <em>CEDIC</em> (100 %). The individual use of an RDT to detect the infection at <em>CSTIF</em> showed a similar sensitivity to that obtained combining it to an ELISA test (92.3% vs 88.5, <em>p</em> = 1). Nonetheless, the generalizability of this result is yet limited and will require of further studies.</p></div>","PeriodicalId":7240,"journal":{"name":"Acta tropica","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0001706X2400264X/pdfft?md5=42b87a676e25ab7e252cf3554575f0b7&pid=1-s2.0-S0001706X2400264X-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Quality assurance of serologic testing for Chagas disease in a primary care setting of rural Paraguay\",\"authors\":\"\",\"doi\":\"10.1016/j.actatropica.2024.107382\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>The diagnosis of Chagas disease mostly relies on the use of multiple serologic tests that are often unavailable in many of the remote settings where the disease is highly prevalent. In the Teniente Irala Fernández Municipality, in central Paraguay, efforts have been made to increase the diagnostic capabilities of specific rural health centres, but no quality assurance of the results produced has been performed. We comparatively analysed the results obtained with 300 samples tested using a commercial rapid diagnostic test (RDT) and enzyme linked immunosorbent assays (ELISA) at the laboratory of the Teniente Irala Fernández Health Center (<em>CSTIF</em>) with those generated upon repeating the tests at an independent well-equipped research laboratory (<em>CEDIC</em>). A subgroup of 52 samples were further tested at Paraguay's Central Public Health Laboratory (<em>LCSP</em>) by means of a different technique to evaluate the diagnostic performance of the tests carried out at <em>CSTIF</em>. We observed an excellent agreement between the ELISA results obtained at <em>CSTIF</em> and <em>CEDIC</em> (kappa coefficients between 0.85 and 0.93 for every kit evaluated), and an overall good performance of the tests carried out at <em>CSTIF</em>. However, the sensitivity of one kit was lower at <em>CSTIF</em> (81.3 %) than at <em>CEDIC</em> (100 %). The individual use of an RDT to detect the infection at <em>CSTIF</em> showed a similar sensitivity to that obtained combining it to an ELISA test (92.3% vs 88.5, <em>p</em> = 1). Nonetheless, the generalizability of this result is yet limited and will require of further studies.</p></div>\",\"PeriodicalId\":7240,\"journal\":{\"name\":\"Acta tropica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-09-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0001706X2400264X/pdfft?md5=42b87a676e25ab7e252cf3554575f0b7&pid=1-s2.0-S0001706X2400264X-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta tropica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0001706X2400264X\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PARASITOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta tropica","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0001706X2400264X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PARASITOLOGY","Score":null,"Total":0}
Quality assurance of serologic testing for Chagas disease in a primary care setting of rural Paraguay
The diagnosis of Chagas disease mostly relies on the use of multiple serologic tests that are often unavailable in many of the remote settings where the disease is highly prevalent. In the Teniente Irala Fernández Municipality, in central Paraguay, efforts have been made to increase the diagnostic capabilities of specific rural health centres, but no quality assurance of the results produced has been performed. We comparatively analysed the results obtained with 300 samples tested using a commercial rapid diagnostic test (RDT) and enzyme linked immunosorbent assays (ELISA) at the laboratory of the Teniente Irala Fernández Health Center (CSTIF) with those generated upon repeating the tests at an independent well-equipped research laboratory (CEDIC). A subgroup of 52 samples were further tested at Paraguay's Central Public Health Laboratory (LCSP) by means of a different technique to evaluate the diagnostic performance of the tests carried out at CSTIF. We observed an excellent agreement between the ELISA results obtained at CSTIF and CEDIC (kappa coefficients between 0.85 and 0.93 for every kit evaluated), and an overall good performance of the tests carried out at CSTIF. However, the sensitivity of one kit was lower at CSTIF (81.3 %) than at CEDIC (100 %). The individual use of an RDT to detect the infection at CSTIF showed a similar sensitivity to that obtained combining it to an ELISA test (92.3% vs 88.5, p = 1). Nonetheless, the generalizability of this result is yet limited and will require of further studies.
期刊介绍:
Acta Tropica, is an international journal on infectious diseases that covers public health sciences and biomedical research with particular emphasis on topics relevant to human and animal health in the tropics and the subtropics.