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

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

doi:10.1186/1475-2875-9-171

Cited by 87Malaria Research and ControlBiosensors and Analytical DetectionTravel-related health issues

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

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Maltha, Jessica, Gillet, Philippe, Bottieau, Emmanuel, Cnops, Lieselotte, van Esbroeck, Marjan, Jacobs, Jan·2010·Malaria Journal

DOI 10.1186/1475-2875-9-171PMC PMC2906498

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Abstract

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.

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Median parasite densities for P. falciparum exceeded the minimum detection threshold documented in laboratory testing of the RDT (>100/μL) and those specified by WHO (>200/μL) in all groups.
“Poor performance observed in this study may be explained by low sensitivity to detect low density parasitaemias, although the median parasite densities for P. falciparum exceeded the minimum detection threshold documented in laboratory testing of the RDT test (>100/µL) [44] and those specified by the WHO (>200/µL) in all groups [45].”
From Accuracy of an HRP-2/panLDH rapid diagnostic test to detect peripheral and placental Plasmodium falciparum infection in Papua New Guinean women with anaemia or suspected malaria (2015) · cites this paper as [44]
The few studies to evaluate RDT for P. vivax infection in non-pregnant individuals report varying performance.
“The few studies to evaluate RDT for P. vivax infection in non-pregnant individuals report varying performance [19, 20, 44].”
From Accuracy of an HRP-2/panLDH rapid diagnostic test to detect peripheral and placental Plasmodium falciparum infection in Papua New Guinean women with anaemia or suspected malaria (2015) · cites this paper as [44]

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Additional file 1 of Low prevalence of Plasmodium falciparum parasites lacking pfhrp2/3 genes among asymptomatic and symptomatic school-age children in Kinshasa, Democratic Republic of Congo
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HRP2 and pLDH performance comparison as rapid diagnostic tools for symptomatic malaria patients at Rugazi HC IV in Rubirizi DistrictPreprint
Nakavuma, A., Musau, I. A., Lumu, H., Atimaaku, P. R., Ankunda, E., Agaba, B. B., Okongo, B., Kalyetsi, R., Ssendyabane, F., Muwanguzi, E., et al. (2023) · Research Square · doi:10.21203/rs.3.rs-3673419/v1

Authors: Maltha, J., Gillet, P., Bottieau, E., Cnops, L., van Esbroeck, M., & Jacobs, J.
Affiliations: Maastricht University (NL)
Instituut voor Tropische Geneeskunde (BE)
Corresponding author: Gillet, Philippe
ORCID: Gillet, Philippe
Bottieau, Emmanuel
Cnops, Lieselotte
Jacobs, Jan
Venue: Malaria Journal
Publisher: Springer Science and Business Media LLC
Published: 2010-06-18
Volume: 9
Issue: 1
Pages: 171-171
ISSN: 1475-2875 (ISSN-L)
DOI: 10.1186/1475-2875-9-171
PMC: PMC2906498
OpenAlex: W2038367955
Cited by: 87
References: 33
Citations by year: 2026: 3 · 2025: 3 · 2024: 4 · 2023: 1 · 2022: 10 · 2021: 3 · 2020: 4 · 2019: 6 · 2018: 5 · 2017: 9 · 2016: 2 · 2015: 3 · 2014: 9 · 2013: 9 · 2012: 5
FWCI: 7.92
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: Malaria Journal (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Research Publications (Maastricht University) (publishedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Travel-related health issues
Keywords: malaria rapid diagnostic tests, Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae, diagnostic sensitivity, parasite density, species misidentification, international travellers
MeSH terms: Histidine-Rich Glycoprotein, Adolescent, Adult, Animals, Antigens, Protozoan, Child, Child, Preschool, Humans, Immunoassay, Infant, L-Lactate Dehydrogenase, Malaria, Microscopy, Middle Aged, Plasmodium, Proteins, Reagent Kits, Diagnostic, Retrospective Studies, Sensitivity and Specificity, Travel, Reproducibility of Results, Protozoan Proteins, Polymerase Chain Reaction

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

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