TY - JOUR
T1 - Performance of a rapid diagnostic test for the detection of cryptosporidium spp. In african children admitted to hospital with diarrhea
AU - Manouana, Gédéon Prince
AU - Lorenz, Eva
AU - Ngwese, Mirabeau Mbong
AU - Moure, Paul Alvyn Nguema
AU - Ascofaré, Oumou Maiga
AU - Akenten, Charity Wiafe
AU - Amuasi, John
AU - Rakotozandrindrainy, Njari
AU - Rakotozandrindrainy, Raphael
AU - Mbwana, Joyce
AU - Lusingu, John
AU - Byrne, Natalie
AU - Melhem, Sophia
AU - Zinsou, Jeannot Frejus
AU - Adegbite, Roméo Bayodé
AU - Hogan, Benedikt
AU - Winter, Doris
AU - May, Jurgen
AU - Kremsner, Peter Gottfried
AU - Borrmann, Steffen
AU - Eibach, Daniel
AU - Adegnika, Ayola Akim
N1 - Funding Information: The project is supported by the DFG funded grant GZ EI 1044/1-1. AAA and MGP are members of CANTAM (EDCTP-RegNet2015-1045) and PANDORA-ID-Net (EDCTP Grant Agreement RIA2016E-1609) networks. MGP is supported by CANTAM (EDCTP-RegNet2015-1045). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2020 Manouana et al.
PY - 2020/7
Y1 - 2020/7
N2 - Background Cryptosporidium is a protozoan parasite that causes mild to severe diarrhoeal disease in humans. To date, several commercial companies have developed rapid immunoassays for the detection of Cryptosporidium infection. However, the challenge is to identify an accurate, simple and rapid diagnostic tool for the estimation of cryptosporidiosis burden. This study aims at evaluating the accuracy of CerTest Crypto, a commercialized rapid diagnostic test (RDT) for the detection of Cryptosporidium antigens in the stool of children presenting with diarrhoea. Methods A cross-sectional study was conducted in four study sites in Sub-Saharan Africa (Gabon, Ghana, Madagascar, and Tanzania), from May 2017 to April 2018. Stool samples were collected from children under 5 years with diarrhoea or a history of diarrhoea within the last 24 hours. All specimens were processed and analyzed using CerTest Crypto RDT against a composite diagnostic panel involving two polymerase chain reaction (PCR) tests (qPCR and RFLP-PCR,) as the gold standard. Results A total of 596 stool samples were collected. Evaluation of the RDT yielded a very low overall sensitivity of 49.6% (confidence interval (CI) 40.1–59.0), a specificity of 92.5% (CI 89.8– 94.7), positive predictive value of 61.3% (CI 50.6–71.2), and negative predictive value of 88.5% (85.3–91.1) when compared to the composite reference standard of qPCR and RFLP-PCR for the detection of Cryptosporidium species. Moreover, the performance of this test varied across different sites. Conclusion The weak performance of the studied RDT suggests the need to carefully evaluate available commercial RDTs before their use as standard tools in clinical trials and community survey of Cryptosporidium infections in pediatric cohorts.
AB - Background Cryptosporidium is a protozoan parasite that causes mild to severe diarrhoeal disease in humans. To date, several commercial companies have developed rapid immunoassays for the detection of Cryptosporidium infection. However, the challenge is to identify an accurate, simple and rapid diagnostic tool for the estimation of cryptosporidiosis burden. This study aims at evaluating the accuracy of CerTest Crypto, a commercialized rapid diagnostic test (RDT) for the detection of Cryptosporidium antigens in the stool of children presenting with diarrhoea. Methods A cross-sectional study was conducted in four study sites in Sub-Saharan Africa (Gabon, Ghana, Madagascar, and Tanzania), from May 2017 to April 2018. Stool samples were collected from children under 5 years with diarrhoea or a history of diarrhoea within the last 24 hours. All specimens were processed and analyzed using CerTest Crypto RDT against a composite diagnostic panel involving two polymerase chain reaction (PCR) tests (qPCR and RFLP-PCR,) as the gold standard. Results A total of 596 stool samples were collected. Evaluation of the RDT yielded a very low overall sensitivity of 49.6% (confidence interval (CI) 40.1–59.0), a specificity of 92.5% (CI 89.8– 94.7), positive predictive value of 61.3% (CI 50.6–71.2), and negative predictive value of 88.5% (85.3–91.1) when compared to the composite reference standard of qPCR and RFLP-PCR for the detection of Cryptosporidium species. Moreover, the performance of this test varied across different sites. Conclusion The weak performance of the studied RDT suggests the need to carefully evaluate available commercial RDTs before their use as standard tools in clinical trials and community survey of Cryptosporidium infections in pediatric cohorts.
UR - http://www.scopus.com/inward/record.url?scp=85088607750&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pntd.0008448
DO - https://doi.org/10.1371/journal.pntd.0008448
M3 - Article
C2 - 32658930
SN - 1935-2727
VL - 14
SP - 1
EP - 12
JO - PLoS neglected tropical diseases
JF - PLoS neglected tropical diseases
IS - 7
M1 - e0008448
ER -