Can malaria rapid diagnostic tests by drug sellers under field conditions classify children 5 years old or less with or without Plasmodium falciparum malaria? Comparison with nested PCR analysis
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Date
2018
Journal Title
Journal ISSN
Volume Title
Publisher
Malaria journal
Abstract
Malaria rapid diagnostic tests (RDTs) available as dipsticks or strips, are simple to perform, easily
interpretable and do not require electricity nor infrastructural investment. Correct interpretation of and compliance
with the RDT results is a challenge to drug sellers. Thus, drug seller interpretation of RDT strips was compared with
laboratory scientist re-reading, and PCR analysis of Plasmodium DNA extracted from RDT nitrocellulose strips and fast
transient analysis (FTA) cards. Malaria RDT cassettes were also assessed as a potential source of Plasmodium DNA.
Methods: A total of 212 children aged between 2 and 60 months, 199 of whom had complete records at two study
drug shops in south western Uganda participated in the study. Duplicate 5 μL samples of capillary blood were picked
from the 212 children, dispensed onto the sample well of the CareStart™ Pf-HRP2 RDT cassette and a FTA, Whatman™
3MM filter paper in parallel. The RDT strip was interpreted by the drug seller within 15–20 min, visually re-read centrally
by laboratory scientist and from it; Plasmodium DNA was recovered and detected by PCR, and compared with
FTA recovered P. falciparum DNA PCR detection.
Results: Malaria positive samples were 62/199 (31.2%, 95% CI 24.9, 38.3) by drug seller interpretation of RDT strip,
59/212 (27.8%, 95% CI 22.2, 34.3) by laboratory scientist, 55/212 (25.9%, 95% CI 20.0, 32.6) by RDT nitrocellulose strip
PCR and 64/212 (30.2%, 95% CI 24.4, 37.7). The overall agreement between the drug seller interpretation and laboratory
scientist re-reading of the RDT strip was 93.0% with kappa value of 0.84 (95% CI 0.75, 0.92). The drug seller
compliance with the reported RDT results was 92.5%. The performance of the three diagnostic strategies compared
with FTA-PCR as the gold standard had sensitivity between 76.6 and 86.9%, specificity above 90%, positive predictive
values ranging from 79.0 to 89.8% and negative predictive values above 90%.
Conclusion: Drug sellers can use RDTs in field conditions and achieve acceptable accuracy for malaria diagnosis,
and they comply with the RDT results. Plasmodium DNA can be recovered from RDT nitrocellulose strips even in the
context of drug shops. Future malaria surveillance and diagnostic quality control studies with RDT cassette as a source
of Plasmodium DNA are recommended.
Description
Keywords
Integrated case management, Rapid diagnostic test, Polymerase chain reaction, Drug seller, Uganda, Febrile illness, Malaria, Private sector, Compliance, External quality assurance
Citation
Kitutu, F. E., Wamani, H., Selling, K. E., Katabazi, F. A., Kuteesa, R. B., Peterson, S., ... & Mårtensson, A. (2018). Can malaria rapid diagnostic tests by drug sellers under field conditions classify children 5 years old or less with or without Plasmodium falciparum malaria? Comparison with nested PCR analysis. Malaria journal, 17(1), 1-12. https://doi.org/10.1186/s12936-018-2508-x