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RESEARCH PRODUCT
Performance of a rapid diagnostic test for the detection of Cryptosporidium spp. in African children admitted to hospital with diarrhea
Mirabeau Mbong NgweseNatalie ByrneJohn LusinguPeter G. KremsnerRoméo Bayodé AdegbiteSophia MelhemGédéon Prince ManouanaEva LorenzEva LorenzDoris WinterOumou Maiga AscofaréJohn H AmuasiBenedikt HoganSteffen BorrmannAyola A. AdegnikaRaphaël RakotozandrindrainyJoyce MbwanaDaniel EibachNjari RakotozandrindrainyCharity Wiafe AkentenJeannot Fréjus ZinsouPaul Alvyn Nguema MoureJürgen Maysubject
0301 basic medicineMaleCryptosporidium infectionCross-sectional studyRC955-962CryptosporidiosisArtificial Gene Amplification and ExtensionPathology and Laboratory MedicinePolymerase Chain ReactionENTAMOEBA-HISTOLYTICAGeographical LocationsFeces0302 clinical medicineArctic medicine. Tropical medicineMedicine and Health SciencesMedicineProtozoansRapid diagnostic testbiologyEukaryotaCryptosporidiumDiarrheaInfectious DiseasesCryptosporidium parvumChild PreschoolGIARDIA-LAMBLIAFemalemedicine.symptomPublic aspects of medicineRA1-1270BURDENPolymorphism Restriction Fragment LengthResearch ArticleDiarrheamedicine.medical_specialty030231 tropical medicineANTIGENCryptosporidiumGastroenterology and HepatologyResearch and Analysis MethodsSensitivity and Specificity03 medical and health sciencesSigns and SymptomsDiagnostic MedicineOOCYSTSInternal medicineparasitic diseasesParasitic DiseasesHumansGabonMolecular Biology TechniquesMolecular BiologyAfrica South of the Saharabusiness.industryPublic Health Environmental and Occupational HealthOrganismsCryptosporidium ParvumBiology and Life SciencesInfantGold standard (test)biology.organism_classificationmedicine.diseaseConfidence intervalParasitic Protozoans030104 developmental biologyCross-Sectional StudiesFECAL SAMPLESPeople and PlacesAfricabusinessdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-07-01 |