TY - JOUR

T1 - Challenges encountered when evaluating an antibody-detecting point-of-care test for Taeniosis in an endemic community in Zambia

T2 - A prospective diagnostic accuracy study

AU - Mubanga, Chishimba

AU - Trevisan, Chiara

AU - Van Damme, Inge

AU - Schmidt, Veronika

AU - Phiri, Isaac K

AU - Zulu, Gideon

AU - Noh, John

AU - Handali, Sukwan

AU - Mambo, Richard

AU - Chembensofu, Mwelwa

AU - Masuku, Maxwell

AU - Reynders, Dries

AU - Jansen, Famke

AU - Bottieau, Emmanuel

AU - Magnussen, Pascal

AU - Winkler, Andrea S

AU - Dorny, Pierre

AU - Mwape, Kabemba E

AU - Gabriel, Sarah

PY - 2021

Y1 - 2021

N2 - Taenia solium taeniosis diagnosis is challenging because current tests perform sub-optimally and/or are expensive, require sophisticated equipment, infrastructure and trained manpower, and therefore are not community deployable. A recently-developed, multi-strip, T. solium point-of-care test (TS POC) for simultaneous detection of tapeworm (TS POC T) and cysticercus (TS POC CC) human antibodies was evaluated for diagnostic accuracy on consecutively recruited community participants in Sinda district, Zambia. All participants were tested using the TS POC test. All test-positives and 20% of the test-negative participants were invited to give a blood and stool sample for reference testing. Three different reference tests were used for taeniosis diagnosis: recombinant rES33 enzyme-linked immunoelectrotransfer blot (rES33 EITB), copro PCR and copro Ag ELISA. Bayesian analysis with probabilistic constraints was used to estimate sensitivity and specificity. In total, 1254 participants were tested with the TS POC test, of whom 13 tested positive using the TS POC T. Based on 161 participants with complete data, the estimated sensitivity and specificity for the TS POC T test were 38% (95% CI: 5-93%) and 99% (95% CI: 98-100%), respectively. The challenge of highly variable inter-assay performance is highlighted. We recommend either increasing the sensitivity or redesigning the test.

AB - Taenia solium taeniosis diagnosis is challenging because current tests perform sub-optimally and/or are expensive, require sophisticated equipment, infrastructure and trained manpower, and therefore are not community deployable. A recently-developed, multi-strip, T. solium point-of-care test (TS POC) for simultaneous detection of tapeworm (TS POC T) and cysticercus (TS POC CC) human antibodies was evaluated for diagnostic accuracy on consecutively recruited community participants in Sinda district, Zambia. All participants were tested using the TS POC test. All test-positives and 20% of the test-negative participants were invited to give a blood and stool sample for reference testing. Three different reference tests were used for taeniosis diagnosis: recombinant rES33 enzyme-linked immunoelectrotransfer blot (rES33 EITB), copro PCR and copro Ag ELISA. Bayesian analysis with probabilistic constraints was used to estimate sensitivity and specificity. In total, 1254 participants were tested with the TS POC test, of whom 13 tested positive using the TS POC T. Based on 161 participants with complete data, the estimated sensitivity and specificity for the TS POC T test were 38% (95% CI: 5-93%) and 99% (95% CI: 98-100%), respectively. The challenge of highly variable inter-assay performance is highlighted. We recommend either increasing the sensitivity or redesigning the test.

U2 - 10.3390/diagnostics11112039

DO - 10.3390/diagnostics11112039

M3 - Journal article

C2 - 34829386

VL - 11

JO - Diagnostics

JF - Diagnostics

SN - 2075-4418

IS - 11

M1 - 2039

ER -