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Can malaria rapid diagnostic tests by drug sellers under feld conditions classify children 5 years old or less with or without Plasmodium falciparum malaria?: Comparison with nested PCR analysis
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH). Makerere Univ, Coll Hlth Sci, Pharm Dept, Kampala, Uganda.
Makerere University School of Public Health.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH), International Child Health and Nutrition.ORCID iD: 0000-0001-8036-168x
Makerere University College of Health Sciences, Department of Medical Microbiology.
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2018 (English)In: Malaria Journal, ISSN 1475-2875, E-ISSN 1475-2875, Vol. 17, article id 365Article in journal (Refereed) Published
Abstract [en]

Background

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 malaria RDT results is a challenge to drug sellers. Thus, drug seller interpretation of malaria RDT strips was compared with laboratory scientist re-reading, and PCR analysis of Plasmodium DNA extracted from malaria RDT nitrocellulose strips and Fast Transient Analysis (FTA) cards. Malaria RDT cassettes are also assessed as 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 west Uganda participated in the study. Duplicate 5μL samples of capillary blood were picked from the 212 children, dispensed onto the sample well of the CareStartTM Pf-HRP2 RDT cassette and a fast transient analysis (FTA), WhatmanTM 3MM filter paper in parallel. The malaria RDT strip was interpreted by the drug seller within 15 to 20 minutes, 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 malaria 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 malaria RDT strip was 93% with kappa value of 0.8 (95 % CI 0.7, 0.9). The drug seller compliance with the reported malaria RDT results and kappa value were 92.5% and 0.8 (95% CI 0.7, 0.9), respectively. 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 value ranging from 79% to 89.8% and negative predictive value above 90%.

Conclusion:

Drug sellers can use of malaria RDTs in field conditions and achieve acceptable accuracy for malaria diagnosis, and they comply with the malaria RDT results. Plasmodium DNA can be recovered from malaria RDT nitrocellulose strips even in the context of drug shops. Future malaria surveillance and diagnostic quality control studies with malaria RDT cassette as a source of Plasmodium DNA are recommended.

Place, publisher, year, edition, pages
2018. Vol. 17, article id 365
Keywords [en]
Integrated case management, Rapid diagnostic test, Polymerase chain reaction, Drug seller, Febrile Illness, Malaria, Private sector, Compliance, External quality assurance
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Research subject
International Health; Social Medicine
Identifiers
URN: urn:nbn:se:uu:diva-359581DOI: 10.1186/s12936-018-2508-xISI: 000447654800005PubMedID: 30326926OAI: oai:DiVA.org:uu-359581DiVA, id: diva2:1244975
Funder
Swedish Research CouncilAvailable from: 2018-09-04 Created: 2018-09-04 Last updated: 2019-02-18Bibliographically approved
In thesis
1. Towards a functioning retail health market: Evaluating the integrated Community Case Management Intervention for Pediatric Febrile Illness in Drug Shops in Rural South Western Uganda
Open this publication in new window or tab >>Towards a functioning retail health market: Evaluating the integrated Community Case Management Intervention for Pediatric Febrile Illness in Drug Shops in Rural South Western Uganda
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Objectives: This thesis examined the health systems effects of implementing the integrated Community Case Management (iCCM) intervention for paediatric febrile illnesses in a retail health market in South Western Uganda. More specifically, it evaluated drug seller interpretation of malaria Rapid Diagnostics Test (RDT) results (study I), adherence to iCCM guidelines (study II) and the intervention effect on households’ perceived quality of drug seller fever care and care-seeking choice. Study IV qualitatively analysed the iCCM intervention implementation and causal mechanisms for observed effects. Improved understanding of such retail health markets will inform policy decisions and interventions for Universal Health Coverage.

Methods: The study used mixed-methods design with an intervention and comparison arm, and pre-test assessment in both study arms. Data collection methods included care-seeker drug shop exit interviews and household surveys using structured questionnaires, focus group discussions, in-depth interviews, review of secondary data and a laboratory analysis of finger-prick capillary blood samples.

Results: Among those tested for malaria parasites, there was 93% (95% CI 88.3, 96.2) agreement between drug sellers and laboratory scientist re-reading and with a kappa value of 0.84 (95% CI 0.75, 0.92) (Study I). The drug seller compliance with the reported malaria RDT results was 92.5% (95% CI 87.9, 95.7) (Study I). The iCCM intervention improved appropriate treatment for uncomplicated malaria by 34.5% (95% CI 8.6, 60.4), for pneumonia symptoms by 54.7% (95% CI 28.4, 81.0) and reduced appropriate treatment for non-bloody diarrhoea -11.2% (95% CI -65.5, 43.1), after adjusting for extraneous variables (Study II). Implementing the iCCM intervention in drug shops decreased the odds of households perceiving drug seller fever care as good but increased the household odds of choosing to seek care from private health facilities versus within the community (Study III). Drug sellers operated in a retail market system influenced by knowledge and actions of care-seekers, CHWs, government health workers and regulators, and also how formal and informal rules and norms were applied (Study IV). Implementation of the iCCM intervention at drug shops was modified and shaped by the emerging actor perceptions and behaviours (Study IV).

Conclusions: This thesis demonstrates the implementation, causal mechanisms and contextual factors of the iCCM intervention in a rural retail health market. Fidelity and quality of iCCM intervention by drug sellers was acceptably high, probably as a result of co-interventions. Interventions in retail health markets should comprise of components that target the multiple actors or influences that shape that market. Multi-component health system interventions are complex to implement and also create complexity in their evaluation. When technologies are involved, their analysis should go beyond their substance as products and view them as items that encapsulate interests of different actors, some of which maybe converging with or competing against societal goals.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 102
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1494
Keywords
Integrated community case management; Malaria, Pneumonia symptoms, Drug shops, Retail health markets, Uganda, Under-five, Evaluation, Mixed-methods, Febrile illness, Universal Health Coverage
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Research subject
Medical Science
Identifiers
urn:nbn:se:uu:diva-359992 (URN)978-91-513-0439-7 (ISBN)
Public defence
2018-10-23, Gunnesalen, Akademiska sjukhuset - Entrance 10, Uppsala, 09:00 (English)
Opponent
Supervisors
Available from: 2018-10-01 Created: 2018-09-07 Last updated: 2018-10-16

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