Field and laboratory comparative evaluation of rapid malaria diagnostic tests versus traditional and molecular techniques in India

Singh, Neeru; Shukla, Man M; Shukla, Mohan K; Mehra, Rajiv K; Sharma, Shweta; Bharti, Praveen K; Singh, Mrigendra P; Singh, Ajay; Gunasekar, Arunachalam

doi:10.1186/1475-2875-9-191

Cited by 76Malaria Research and ControlBiosensors and Analytical DetectionClinical Laboratory Practices and Quality Control

Field and laboratory comparative evaluation of rapid malaria diagnostic tests versus traditional and molecular techniques in India

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Singh, Neeru, Shukla, Man M, Shukla, Mohan K, Mehra, Rajiv K, Sharma, Shweta, Bharti, Praveen K, Singh, Mrigendra P, Singh, Ajay +1 more·2010·Malaria Journal

DOI 10.1186/1475-2875-9-191PMC PMC2905433

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Abstract

BACKGROUND: Malaria presents a diagnostic challenge in most tropical countries. Microscopy remains the gold standard for diagnosing malaria infections in clinical practice and research. However, microscopy is labour intensive, requires significant skills and time, which causes therapeutic delays. The objective of obtaining result quickly from the examination of blood samples from patients with suspected malaria is now made possible with the introduction of rapid malaria diagnostic tests (RDTs). Several RDTs are available, which are fast, reliable and simple to use and can detect Plasmodium falciparum and non-falciparum infections or both. A study was conducted in tribal areas of central India to measure the overall performance of several RDTs for diagnosis of P. falciparum and non-falciparum infections in comparison with traditional and molecular techniques. Such data will be used to guide procurement decisions of policy makers and programme managers. METHODS: Five commercially available RDTs were tested simultaneously in field in parallel with peripheral blood smears in outbreak-affected areas. The evaluation is designed to provide comparative data on the performance of each RDT. In addition, molecular method i.e. polymerase chain reaction (PCR) was also carried out to compare all three methods. RESULTS: A total of 372 patients with a clinical suspicion of malaria from Bajag Primary Health Centre (PHC) of district Dindori and Satanwada PHC of district Shivpuri attending the field clinics of Regional Medical Research Centre were included in the study. The analysis revealed that the First Response Malaria Antigen pLDH/HRP2 combo test was 94.7% sensitive (95% CI 89.5-97.7) and 69.9% specific (95% CI 63.6-75.6) for P. falciparum. However, for non-falciparum infections (Plasmodium vivax) the test was 84.2% sensitive (95% CI 72.1-92.5) and 96.5% specific (95% CI 93.8-98.2). The Parascreen represented a good alternative. All other RDTs were relatively less sensitive for both P. falciparum and non-falciparum infections. CONCLUSIONS: The results in this study show comparative performance between microscopy, various RDTs and PCR. Despite some inherent limitation in the five RDTs tested, First Response clearly has an advantage over other RDTs. The results suggest that RDTs could play and will play an important role in malaria diagnosis.

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RDTs demonstrated variable sensitivities compared with PCR for the diagnosis of malaria in nonpregnant symptomatic populations.
“RDTs also demonstrated variable sensitivities compared with PCR for the diagnosis of malaria in nonpregnant symptomatic populations [19–22].”
From Diagnosing malaria in pregnancy: An update (2012) · cites this paper as [21]

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Self-citation

Authors: Singh, N., Shukla, M. M., Shukla, M. K., Mehra, R. K., Sharma, S., Bharti, P. K., Singh, M. P., Singh, A., & Gunasekar, A.
Affiliations: Indian Council of Medical Research (IN)
World Health Organization - India (IN)
Corresponding author: Singh, Neeru
ORCID: Singh, Neeru
Shukla, Man M
Sharma, Shweta
Bharti, Praveen K
Singh, Mrigendra P
Singh, Ajay
Venue: Malaria Journal
Publisher: Springer Science and Business Media LLC
Published: 2010-07-05
Volume: 9
Issue: 1
Pages: 191-191
ISSN: 1475-2875 (ISSN-L)
DOI: 10.1186/1475-2875-9-191
PMC: PMC2905433
OpenAlex: W2116767616
Cited by: 76
References: 28
Citations by year: 2025: 1 · 2024: 1 · 2023: 3 · 2022: 6 · 2020: 2 · 2019: 3 · 2018: 5 · 2017: 5 · 2016: 7 · 2015: 4 · 2014: 10 · 2013: 10 · 2012: 14
FWCI: 9.19
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/2.0 (tdm)
Locations: Malaria Journal (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords: Plasmodium falciparum, Plasmodium vivax, malaria diagnosis, sensitivity and specificity, PCR, diagnostic test comparison, tribal areas, India
MeSH terms: Adolescent, Adult, Aged, Blood Specimen Collection, Child, Child, Preschool, False Positive Reactions, Female, Humans, Immunoassay, India, Infant, Male, Microscopy, Middle Aged, Plasmodium falciparum, Plasmodium vivax, Predictive Value of Tests, Reagent Kits, Diagnostic, Sensitivity and Specificity, Polymerase Chain Reaction, Malaria, Falciparum, Malaria, Vivax, Young Adult

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Field and laboratory comparative evaluation of rapid malaria diagnostic tests versus traditional and molecular techniques in India

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