Evaluation of the Palutop+4 malaria rapid diagnostic test in a non-endemic setting.

Abstract

BACKGROUND:

Palutop+4 (All. Diag, Strasbourg, France), a four-band malaria rapid diagnostic test (malaria RDT) targeting the histidine-rich protein 2 (HRP-2), Plasmodium vivax-specific parasite lactate dehydrogenase (Pv-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) was evaluated in a non-endemic setting on stored whole blood samples from international travellers suspected of malaria.

METHODS:

Microscopy corrected by PCR was the reference method. Samples include those infected by Plasmodium falciparum (n = 323), Plasmodium vivax (n = 97), Plasmodium ovale (n = 73) and Plasmodium malariae (n = 25) and 95 malaria negative samples.

RESULTS:

The sensitivities for the diagnosis of P. falciparum, P. vivax, P. malariae and P. ovale were 85.1%, 66.0%, 32.0% and 5.5%. Sensitivities increased at higher parasite densities and reached 90.0% for P. falciparum >100/microl and 83.8% for P. vivax > 500/microl. Fourteen P. falciparum samples reacted with the Pv-pLDH line, one P. vivax sample with the HRP-2 line, and respectively two and four P. ovale and P. malariae samples reacted with the HRP-2 line. Two negative samples gave a signal with the HRP-2 line. Faint and weak line intensities were observed for 129/289 (44.6%) HRP-2 lines in P. falciparum samples, for 50/64 (78.1%) Pv-pLDH lines in P. vivax samples and for 9/13 (69.2%) pan-pLDH lines in P. ovale and P. malariae samples combined. Inter-observer reliabilities for positive and negative readings were excellent for the HRP-2 and Pv-pLDH lines (overall agreement > 92.0% and kappa-values for each pair of readers >or= 0.88), and good for the pan-pLDH line (85.5% overall agreement and kappa-values >or= 0.74).

CONCLUSIONS:

Palutop+4 performed moderately for the detection of P. falciparum and P. vivax, but sensitivities were lower than those of three-band malaria RDTs.

• Authors: David P J van Dijk, Philippe Gillet, Erika Vlieghe, Lieselotte Cnops, Marjan van Esbroeck, Jan Jacobs
• Journal: Malaria journal (Malar J) Vol. 8 Pg. 293 (Dec 12 2009) ISSN: 1475-2875 [Electronic] England
• PMID: 20003378 (Publication Type: Evaluation Study, Journal Article)

Chemical References

• Proteins
• Reagent Kits, Diagnostic
• histidine-rich proteins
• L-Lactate Dehydrogenase

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Animals
• Child
• Child, Preschool
• Confidence Intervals
• Diagnostic Tests, Routine (methods)
• False Positive Reactions
• Female
• France
• Humans
• Infant
• L-Lactate Dehydrogenase
• Malaria (diagnosis, epidemiology, parasitology)
• Male
• Microscopy (methods)
• Middle Aged
• Plasmodium (classification, isolation & purification)
• Polymerase Chain Reaction (methods)
• Proteins
• Reagent Kits, Diagnostic
• Reproducibility of Results
• Retrospective Studies
• Sensitivity and Specificity
• Travel
• Young Adult