Journal Article

Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting

Gillet, Philippe, Cnops, Lieselotte, Jacobs, Jan, Bottieau, Emmanuel, van Esbroeck, Marjan, Maltha, Jessica

2010

Overview

Background Malaria Rapid Diagnostic Tests (RDTs) are widely used for diagnosing malaria. The present retrospective study evaluated the CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test targeting the Plasmodium falciparum specific antigen histidine-rich protein (HRP-2) and the pan- Plasmodium antigen lactate dehydrogenase (pLDH) in a reference setting. Methods The CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test was evaluated on a collection of samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included were P. falciparum (n = 320), Plasmodium vivax (n = 76), Plasmodium ovale (n = 76), Plasmodium malariae (n = 23) and Plasmodium negative samples (n = 95). Results Overall sensitivity for the detection of P. falciparum was 88.8%, increasing to 94.3% and 99.3% at parasite densities above 100 and 1,000/μl respectively. For P. vivax, P. ovale and P. malariae , overall sensitivities were 77.6%, 18.4% and 30.4% respectively. For P. vivax sensitivity reached 90.2% for parasite densities above 500/μl. Incorrect species identification occurred in 11/495 samples (2.2%), including 8/320 (2.5%) P. falciparum samples which generated only the pan-pLDH line. For P. falciparum samples, 205/284 (72.2%) HRP-2 test lines had strong or medium line intensities, while for all species the pan-pLDH lines were less intense, especially in the case of P. ovale . Agreement between observers was excellent (kappa values > 0.81 for positive and negative readings) and test results were reproducible. The test was easy to perform with good clearing of the background. Conclusion The CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test performed well for the detection of P. falciparum and P. vivax , but sensitivities for P. ovale and P. malariae were poor.

• Publisher: BioMed Central,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Agreements / Animals / Antigens / Antigens, Protozoan - immunology / Biomedical and Life Sciences / Biomedicine / Child / Child, Preschool / Detection / Diagnostic tests / DNA / Entomology / Erythrocytes / Histidine / Human diseases / Humans / Immunoassay - methods / Infant / Infections / Infectious Diseases / L-Lactate dehydrogenase / L-Lactate Dehydrogenase - immunology / Laboratories / Lactate / Lactic acid / Malaria / Malaria - diagnosis / Malaria - parasitology / Microbiology / Microscopy / Middle Aged / Multivariate analysis / Nucleotide sequence / Parasites / Parasitology / PCR / Plasmodium / Plasmodium - classification / Plasmodium - isolation & purification / Plasmodium falciparum / Plasmodium malariae / Plasmodium ovale / Plasmodium vivax / Polymerase Chain Reaction / Proteins - analysis / Proteins - immunology / Protozoan Proteins - immunology / Public Health / Reagent Kits, Diagnostic - standards / Reproducibility of Results / Retrospective Studies / Sensitivity and Specificity / Species identification / Travel / Travellers / Tropical Medicine / Vector-borne diseases