Evaluation of the OnSite (Pf/Pan) rapid diagnostic test for diagnosis of clinical malaria

Malaria Journal

Research

Rashidul Haque¹  Mohammad Shafiul Alam¹  Wasif A Khan¹  Khaja Mohiuddin¹  Mohammad Sharif Hossain¹  Abu Naser Mohon¹  Milka Patracia Podder²  Rubayet Elahi³ 

[1] International Centre for Diarrheal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh;International Centre for Diarrheal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh;Department of Biology, Memorial University of Newfoundland, St. John’s, Canada;International Centre for Diarrheal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh;Department of Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences (UAMS), Little Rock, AR, USA;

关键词: Malaria;    Malaria Case;    Rapid Diagnostic Test;    Vivax Malaria;    Malaria Diagnosis;   

DOI  :  10.1186/1475-2875-11-415

 received in 2012-10-14, accepted in 2012-12-10,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundAccurate diagnosis of malaria is an essential prerequisite for proper treatment and drug resistance monitoring. Microscopy is considered the gold standard for malaria diagnosis but has limitations. ELISA, PCR, and Real Time PCR are also used to diagnose malaria in reference laboratories, although their application at the field level is currently not feasible. Rapid diagnostic tests (RDTs) however, have been brought into field operation and widely adopted in recent days. This study evaluates OnSite (Pf/Pan) antigen test, a new RDT introduced by CTK Biotech Inc, USA for malaria diagnosis in a reference setting.MethodsBlood samples were collected from febrile patients referred for malaria diagnosis by clinicians. Subjects were included in this study from two different Upazila Health Complexes (UHCs) situated in two malaria endemic districts of Bangladesh. Microscopy and nested PCR were considered the gold standard in this study. OnSite (Pf/Pan) RDT was performed on preserved whole blood samples.ResultsIn total, 372 febrile subjects were included in this study. Of these subjects, 229 (61.6%) tested positive for Plasmodium infection detected by microscopy and nested PCR. OnSite (Pf/Pan) RDT was 94.2% sensitive (95% CI, 89.3-97.3) and 99.5% specific (95% CI, 97.4-00.0) for Plasmodium falciparum diagnosis and 97.3% sensitive (95% CI, 90.5-99.7) and 98.7% specific (95% CI, 96.6-99.6) for Plasmodium vivax diagnosis. Sensitivity varied with differential parasite count for both P. falciparum and P. vivax. The highest sensitivity was observed in febrile patients with parasitaemia that ranged from 501–1,000 parasites/μL regardless of the Plasmodium species.ConclusionThe new OnSite (Pf/Pan) RDT is both sensitive and specific for symptomatic malaria diagnosis in standard laboratory conditions.

【 授权许可】

Unknown   
© Mohon et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.