Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Study Area
2.3. Recruitment of Participants
2.4. Sampling and Sample Processing
2.5. Test Methods
2.5.1. The Prototype Taenia solium Point of Care Test (TS POC)
2.5.2. Reference Tests
2.6. Treatment and Purging of Taeniosis Positive Participants
2.7. Data Analysis
2.8. Trial Registration
3. Results
3.1. Flow and Demographic Characteristics of Participants
3.2. Bayesian Estimates of Performance Characteristics
3.3. Agreement between Tests
3.4. Treatment and Purging of Test Positive Participants
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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TS POC T | rES33 EITB | Copro PCR | Copro Ag ELISA | n |
---|---|---|---|---|
1 | 1 | 1 | 1 | 0 |
1 | 1 | 1 | 0 | 1 |
1 | 1 | 0 | 1 | 0 |
1 | 1 | 0 | 0 | 3 |
1 | 0 | 1 | 1 | 0 |
1 | 0 | 1 | 0 | 0 |
1 | 0 | 0 | 1 | 0 |
1 | 0 | 0 | 0 | 3 |
0 | 1 | 1 | 1 | 0 |
0 | 1 | 1 | 0 | 1 |
0 | 1 | 0 | 1 | 4 |
0 | 1 | 0 | 0 | 39 |
0 | 0 | 1 | 1 | 0 |
0 | 0 | 1 | 0 | 0 |
0 | 0 | 0 | 1 | 9 |
0 | 0 | 0 | 0 | 101 |
Parameters | TS POC T | rES33 EITB | Copro PCR | Copro Ag ELISA |
---|---|---|---|---|
Se (95% CI) | 38 (5–93) | 95 (91–98) | 42 (6–93) | 40 (12–74) |
Sp (95% CI) | 99 (98–100) | 74 (70–79) | 99 (97–100) | 91 (85–95) |
PPV (95% CI) | 40 (5–80) | 6 (1–15) | 45 (4–96) | 7 (1–25) |
NPV (95% CI) | 99 (96–100) | 100 (99–100) | 99 (96–100) | 99 (97–100) |
TS POC T | rES33 EITB | Copro PCR | |
---|---|---|---|
TS POC T | NA a | ||
rES33 EITB |
κ = 0.05 ppos = 0.07 pneg = 0.91 | NA | |
Copro PCR |
κ = 0.21 ppos = 0.21 pneg = 0.99 |
κ = 0.03 ppos = 0.03 pneg = 0.91 | NA |
Copro Ag ELISA |
κ = −0.02 ppos = 0 pneg = 0.97 |
κ = −0.02 ppos = 0.06 pneg = 0.89 |
κ = −0.01 ppos = 0 pneg = 0.98 |
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Mubanga, C.; Trevisan, C.; Van Damme, I.; Schmidt, V.; Phiri, I.K.; Zulu, G.; Noh, J.; Handali, S.; Mambo, R.; Chembensofu, M.; et al. Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study. Diagnostics 2021, 11, 2039. https://doi.org/10.3390/diagnostics11112039
Mubanga C, Trevisan C, Van Damme I, Schmidt V, Phiri IK, Zulu G, Noh J, Handali S, Mambo R, Chembensofu M, et al. Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study. Diagnostics. 2021; 11(11):2039. https://doi.org/10.3390/diagnostics11112039
Chicago/Turabian StyleMubanga, Chishimba, Chiara Trevisan, Inge Van Damme, Veronika Schmidt, Isaac K. Phiri, Gideon Zulu, John Noh, Sukwan Handali, Richard Mambo, Mwelwa Chembensofu, and et al. 2021. "Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study" Diagnostics 11, no. 11: 2039. https://doi.org/10.3390/diagnostics11112039