Evaluation of a rapid and inexpensive dipstick assay for the diagnosis of Plasmodium falciparum malaria

Rapid, accurate and affordable methods are needed for the diagnosis of malaria. Reported here is an evaluation of a new immunochromatographic strip, the PATH Falciparum Malaria IC Strip, which is impregnated with an immobilized IgM monoclonal antibody that binds to the HRP-II antigen of Plasmodium f...

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Bibliographic Details
Published in:Bulletin of the World Health Organization 1999-07, Vol.77 (7), p.553-559
Main Authors: MILLS, C. D, BURGESS, D. C. H, TAYLOR, H. J, KAIN, K. C
Format: Article
Language:English
Subjects:
Agreements
Analysis. Health state
Antibodies, Monoclonal - immunology
Antigens
Biological and medical sciences
Confidence Intervals
Diagnosis
Diagnostic tests
Epidemiology
Evaluation Studies as Topic
General aspects
Human protozoal diseases
Humans
Immunoglobulin M - immunology
Infections
Infectious diseases
Malaria
Malaria, Falciparum - blood
Malaria, Falciparum - diagnosis
Medical sciences
Microscopy
Monoclonal antibodies
Parasites
Parasitic diseases
Patients
Polymerase Chain Reaction
Protozoal diseases
Public health. Hygiene
Public health. Hygiene-occupational medicine
Reagent Strips
Sensitivity and Specificity
Travel
Tropical diseases
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Summary:Rapid, accurate and affordable methods are needed for the diagnosis of malaria. Reported here is an evaluation of a new immunochromatographic strip, the PATH Falciparum Malaria IC Strip, which is impregnated with an immobilized IgM monoclonal antibody that binds to the HRP-II antigen of Plasmodium falciparum. In contrast to other commercially available kits marketed for the rapid diagnosis of falciparum malaria, this kit should be affordable in the malaria-endemic world. Using microscopy and polymerase chain reaction (PCR)-based methods as reference standards, we compared two versions of the PATH test for the detection of P. falciparum infection in 200 febrile travellers. As determined by PCR and microscopy, 148 travellers had malaria, 50 of whom (33.8%) were infected with P. falciparum. Compared with PCR, the two versions of the PATH test had initial sensitivities of 90% and 88% and specificities of 97% and 96%, respectively, for the detection of falciparum malaria. When discrepant samples were retested blindly with a modified procedure (increased sample volume and longer washing step) the sensitivity and specificity of both kits improved to 96% and 99%, respectively. The two remaining false negatives occurred in samples with < 100 parasites per microliter of blood. The accuracy, simplicity and predicted low cost may make this test a useful diagnostic tool in malaria-endemic areas.
ISSN:0042-9686
1564-0604