The usefulness of a new rapid diagnostic test, the First Response® Malaria Combo (pLDH/HRP2) card test, for malaria diagnosis in the forested belt of central India

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Abstract

Background

Malaria presents a diagnostic challenge in tribal belt of central India where two Plasmodium species, Plasmodium falciparum and Plasmodium vivax, are prevalent. In these areas, rapid detection of the malaria parasites and early treatment of infection remain the most important goals of disease management. Therefore, the usefulness of a new rapid diagnostic (RDT), the First Response ^®Combo Malaria Ag (pLDH/HRP2) card test was assessed for differential diagnosis between P. falciparum with other Plasmodium species in remote villages of Jabalpur district.

Methods

A finger prick blood sample was collected to prepare blood smear and for testing with the RDT after taking informed consent. The figures for sensitivity, specificity, accuracy and predictive values were calculated using microscopy as gold standard.

Results

Analysis revealed that overall, the RDT was 93% sensitive, 85% specific with a positive predictive value (PPV) of 79%, and a negative predictive value (NPV) of 95%. The accuracy 88% and J-index was 0.74. For P. falciparum, the sensitivity and specificity of the test were 96% and 95% respectively, with a PPV of 85% and a NPV of 99%. The RDT accuracy 95% and J-index was 0.84. For non-falciparum malaria, the sensitivity, specificity and accuracy were 83%, 94% and 92% respectively with a PPV of 69% and a NPV of 97%.

Conclusion

The RDTs are easy to use, reliable and simple to interpret. RDTs are more suited to health workers in situations where health services are deficient or absent. Therefore, the test can be used as an epidemiological tool for the rapid screening of malaria.

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Most cited references 30

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Rapid diagnostic tests for malaria parasites.

Anthony Moody (2002)

Malaria presents a diagnostic challenge to laboratories in most countries. Endemic malaria, population movements, and travelers all contribute to presenting the laboratory with diagnostic problems for which it may have little expertise available. Drug resistance and genetic variation has altered many accepted morphological appearances of malaria species, and new technology has given an opportunity to review available procedures. Concurrently the World Health Organization has opened a dialogue with scientists, clinicians, and manufacturers on the realistic possibilities for developing accurate, sensitive, and cost-effective rapid diagnostic tests for malaria, capable of detecting 100 parasites/microl from all species and with a semiquantitative measurement for monitoring successful drug treatment. New technology has to be compared with an accepted "gold standard" that makes comparisons of sensitivity and specificity between different methods. The majority of malaria is found in countries where cost-effectiveness is an important factor and ease of performance and training is a major consideration. Most new technology for malaria diagnosis incorporates immunochromatographic capture procedures, with conjugated monoclonal antibodies providing the indicator of infection. Preferred targeted antigens are those which are abundant in all asexual and sexual stages of the parasite and are currently centered on detection of HRP-2 from Plasmodium falciparum and parasite-specific lactate dehydrogenase or Plasmodium aldolase from the parasite glycolytic pathway found in all species. Clinical studies allow effective comparisons between different formats, and the reality of nonmicroscopic diagnoses of malaria is considered.

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Plasmodium vivax Malaria

Dhanpat K. Kochar, Vishal Saxena, Narvachan Singh … (2005)

We report 11 cases of severe Plasmodium vivax malaria in Bikaner (western India). Patients exhibited cerebral malaria, renal failure, circulatory collapse, severe anemia, hemoglobinurea, abnormal bleeding, acute respiratory distress syndrome, and jaundice. Peripheral blood microscopy, parasite antigen–based assays, and parasite 18s rRNA gene–based polymerase chain reaction showed the presence of P. vivax and absence of P. falciparum.

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Peter L Chiodini, Katherine Bowers, Pernille Jorgensen … (2007)

Malaria rapid diagnostic tests (RDTs) have performed well in a variety of studies, but recent reports have described sensitivity for Plasmodium falciparum as significantly lower than that required for operational deployment. Exposure to high temperature has been suggested as an explanation. This study assessed the temperature stability of two different Plasmodium lactate dehydrogenase (pLDH)- and three histidine-rich protein 2 (HRP2)-detecting RDTs. One HRP2 test proved insufficiently sensitive for assessment. After incubation at 35, 45 and 60 degrees C, two RDTs detecting pLDH showed a substantial fall in percentage test line positivity over time, which was not seen with the remaining two HRP-2-based RDTs. For the particular products studied, variability was high, with the pLDH-based RDTs being less sensitive than HRP2-based RDTs against the sample of P. falciparum used and more susceptible to heat-induced damage, but the reasons for this are unclear. The performance of malaria RDTs can be adversely affected at the temperatures to which they will be exposed when transported to, and used in, the rural tropics.

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Author and article information

Journal

Journal ID (nlm-ta): Malar J

Title: Malaria Journal

Publisher: BioMed Central

ISSN (Electronic): 1475-2875

Publication date Collection: 2008

Publication date (Electronic): 11 July 2008

Volume: 7

Page: 126

Affiliations

[1 ]National Institute of Malaria Research, Field Station, Jabalpur, Madhya Pradesh, India

[2 ]Regional Medical Research Centre for Tribals, Jabalpur, Madhya Pradesh, India

[3 ]National Institute of Malaria Research, Delhi, India

Article

Publisher ID: 1475-2875-7-126

DOI: 10.1186/1475-2875-7-126

PMC ID: 2478667

PubMed ID: 18620560

SO-VID: 9abb1ddc-9670-4b29-b81b-7ee4e30d01b0

License:

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.