Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density

Michael Christian; Lenny Lia Ekawati; Aa Raka Pratama; Syavira Cahyaningati; Hermina K. Bere; Muhammad Rustam; Ichsan Kalbuadi; Jeltsin Andini; Jeng Yuliana; Ihsan Fadilah; Benedikt Ley; Kamala Thriemer; Ric N. Price; Inge Sutanto; J. Kevin Baird

doi:10.1186/s12936-025-05276-y

Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density

Michael Christian, Lenny Lia Ekawati, Aa Raka Pratama, Syavira Cahyaningati, Hermina K. Bere, Muhammad Rustam, Ichsan Kalbuadi, Jeltsin Andini, Jeng Yuliana, Ihsan Fadilah, Benedikt Ley, Kamala Thriemer, Ric N. Price, Inge Sutanto, J. Kevin Baird

Global and Tropical Health

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Abstract

Background: As a widely accepted field standard diagnostic tool for malaria, microscopic examination is often difficult to perform in resource-poor settings. The immunochromatographic HRP2/pLDH (Pf/Pan) Rapid Diagnostic Tests (RDTs) serve as alternatives to microscopic examination for falciparum and non-falciparum malaria in co-endemic areas by detecting the histidine-rich protein 2 (HRP2) and pan-plasmodial lactate dehydrogenase (pLDH) antigen. However, Pf/Pan RDTs do not directly quantify parasitaemia. In this study, the diagnostic performance of Pf/Pan RDT and its association with parasite density was examined. Methods: Blood smears from patients who were screened for PRIMA Clinical Trial (Trial Registration Number: NCT03916003) conducted in East Sumba, Indonesia, and enrolled to its sub-study, ACROSS, were examined for microscopic examination and RDT using CareStart^™ Malaria HRP2/pLDH (Pf/PAN) Combo (CareStart^™ Pf/Pan RDT). Results were analysed for both diagnostic performance of RDT and its relationship with parasite density using a logistic regression model. Results: 317 participants were included in this study and 158 (49.8%) were malaria positive by microscopy. Among all malaria-positive participants, Plasmodium falciparum infections accounted for 149 (94.3%) cases. The sensitivity and specificity of HRP2 band were 97.3% (95% CI 93.3–99.2) and 97.6% (95% CI 94.0–99.4), respectively, while that of pLDH band were 87.3% (95% CI 81.1–92.0) and 100% (95% CI 97.7–100). For each ten-fold increase in parasite density, the RDT had 12 times the odds of returning Pf/Pan-positive results (n = 126) compared to Pf-positive (n = 19) (OR: 12.1; 95% CI 5.18 to 34.8; p < 0.001). Conclusions: CareStart^™ Pf/Pan RDT is reliable in diagnosing falciparum malaria and Pf/Pan-positive results indicate higher parasite density. Pf/Pan-positive results should alert the clinical staff of the increased risk of poor clinical outcome, and should be prioritized for microscopic examination compared to Pf-positive results.

Original language	English
Article number	39
Pages (from-to)	1-11
Number of pages	11
Journal	Malaria Journal
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s12936-025-05276-y
Publication status	Published - Dec 2025

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10.1186/s12936-025-05276-y

125077611-oaFinal published version, 1.13 MBLicence: CC BY

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Christian, M., Ekawati, L. L., Pratama, A. R., Cahyaningati, S., Bere, H. K., Rustam, M., Kalbuadi, I., Andini, J., Yuliana, J., Fadilah, I., Ley, B., Thriemer, K., Price, R. N., Sutanto, I., & Baird, J. K. (2025). Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density. Malaria Journal, 24(1), 1-11. Article 39. https://doi.org/10.1186/s12936-025-05276-y

@article{e19ec2d8c7a6423794cb40ae3c8c4066,

title = "Evaluation of CareStart{\texttrademark} malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density",

abstract = "Background: As a widely accepted field standard diagnostic tool for malaria, microscopic examination is often difficult to perform in resource-poor settings. The immunochromatographic HRP2/pLDH (Pf/Pan) Rapid Diagnostic Tests (RDTs) serve as alternatives to microscopic examination for falciparum and non-falciparum malaria in co-endemic areas by detecting the histidine-rich protein 2 (HRP2) and pan-plasmodial lactate dehydrogenase (pLDH) antigen. However, Pf/Pan RDTs do not directly quantify parasitaemia. In this study, the diagnostic performance of Pf/Pan RDT and its association with parasite density was examined. Methods: Blood smears from patients who were screened for PRIMA Clinical Trial (Trial Registration Number: NCT03916003) conducted in East Sumba, Indonesia, and enrolled to its sub-study, ACROSS, were examined for microscopic examination and RDT using CareStart{\texttrademark} Malaria HRP2/pLDH (Pf/PAN) Combo (CareStart{\texttrademark} Pf/Pan RDT). Results were analysed for both diagnostic performance of RDT and its relationship with parasite density using a logistic regression model. Results: 317 participants were included in this study and 158 (49.8%) were malaria positive by microscopy. Among all malaria-positive participants, Plasmodium falciparum infections accounted for 149 (94.3%) cases. The sensitivity and specificity of HRP2 band were 97.3% (95% CI 93.3–99.2) and 97.6% (95% CI 94.0–99.4), respectively, while that of pLDH band were 87.3% (95% CI 81.1–92.0) and 100% (95% CI 97.7–100). For each ten-fold increase in parasite density, the RDT had 12 times the odds of returning Pf/Pan-positive results (n = 126) compared to Pf-positive (n = 19) (OR: 12.1; 95% CI 5.18 to 34.8; p < 0.001). Conclusions: CareStart{\texttrademark} Pf/Pan RDT is reliable in diagnosing falciparum malaria and Pf/Pan-positive results indicate higher parasite density. Pf/Pan-positive results should alert the clinical staff of the increased risk of poor clinical outcome, and should be prioritized for microscopic examination compared to Pf-positive results.",

keywords = "CareStart Malaria HRP2/pLDH(Pf/PAN) Combo, HRP2, Malaria diagnosis, Parasitaemia, Parasite density, Pf/Pan, Plasmodium falciparum malaria, PLDH, Rapid diagnostic test, RDT",

author = "Michael Christian and Ekawati, {Lenny Lia} and Pratama, {Aa Raka} and Syavira Cahyaningati and Bere, {Hermina K.} and Muhammad Rustam and Ichsan Kalbuadi and Jeltsin Andini and Jeng Yuliana and Ihsan Fadilah and Benedikt Ley and Kamala Thriemer and Price, {Ric N.} and Inge Sutanto and Baird, {J. Kevin}",

year = "2025",

month = dec,

doi = "10.1186/s12936-025-05276-y",

language = "English",

volume = "24",

pages = "1--11",

journal = "Malaria Journal",

issn = "1475-2875",

publisher = "BioMed Central",

number = "1",

}

Christian, M, Ekawati, LL, Pratama, AR, Cahyaningati, S, Bere, HK, Rustam, M, Kalbuadi, I, Andini, J, Yuliana, J, Fadilah, I, Ley, B , Thriemer, K , Price, RN, Sutanto, I & Baird, JK 2025, 'Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density', Malaria Journal, vol. 24, no. 1, 39, pp. 1-11. https://doi.org/10.1186/s12936-025-05276-y

Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density. / Christian, Michael; Ekawati, Lenny Lia; Pratama, Aa Raka et al.
In: Malaria Journal, Vol. 24, No. 1, 39, 12.2025, p. 1-11.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density

AU - Christian, Michael

AU - Ekawati, Lenny Lia

AU - Pratama, Aa Raka

AU - Cahyaningati, Syavira

AU - Bere, Hermina K.

AU - Rustam, Muhammad

AU - Kalbuadi, Ichsan

AU - Andini, Jeltsin

AU - Yuliana, Jeng

AU - Fadilah, Ihsan

AU - Ley, Benedikt

AU - Thriemer, Kamala

AU - Price, Ric N.

AU - Sutanto, Inge

AU - Baird, J. Kevin

PY - 2025/12

Y1 - 2025/12

N2 - Background: As a widely accepted field standard diagnostic tool for malaria, microscopic examination is often difficult to perform in resource-poor settings. The immunochromatographic HRP2/pLDH (Pf/Pan) Rapid Diagnostic Tests (RDTs) serve as alternatives to microscopic examination for falciparum and non-falciparum malaria in co-endemic areas by detecting the histidine-rich protein 2 (HRP2) and pan-plasmodial lactate dehydrogenase (pLDH) antigen. However, Pf/Pan RDTs do not directly quantify parasitaemia. In this study, the diagnostic performance of Pf/Pan RDT and its association with parasite density was examined. Methods: Blood smears from patients who were screened for PRIMA Clinical Trial (Trial Registration Number: NCT03916003) conducted in East Sumba, Indonesia, and enrolled to its sub-study, ACROSS, were examined for microscopic examination and RDT using CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo (CareStart™ Pf/Pan RDT). Results were analysed for both diagnostic performance of RDT and its relationship with parasite density using a logistic regression model. Results: 317 participants were included in this study and 158 (49.8%) were malaria positive by microscopy. Among all malaria-positive participants, Plasmodium falciparum infections accounted for 149 (94.3%) cases. The sensitivity and specificity of HRP2 band were 97.3% (95% CI 93.3–99.2) and 97.6% (95% CI 94.0–99.4), respectively, while that of pLDH band were 87.3% (95% CI 81.1–92.0) and 100% (95% CI 97.7–100). For each ten-fold increase in parasite density, the RDT had 12 times the odds of returning Pf/Pan-positive results (n = 126) compared to Pf-positive (n = 19) (OR: 12.1; 95% CI 5.18 to 34.8; p < 0.001). Conclusions: CareStart™ Pf/Pan RDT is reliable in diagnosing falciparum malaria and Pf/Pan-positive results indicate higher parasite density. Pf/Pan-positive results should alert the clinical staff of the increased risk of poor clinical outcome, and should be prioritized for microscopic examination compared to Pf-positive results.

AB - Background: As a widely accepted field standard diagnostic tool for malaria, microscopic examination is often difficult to perform in resource-poor settings. The immunochromatographic HRP2/pLDH (Pf/Pan) Rapid Diagnostic Tests (RDTs) serve as alternatives to microscopic examination for falciparum and non-falciparum malaria in co-endemic areas by detecting the histidine-rich protein 2 (HRP2) and pan-plasmodial lactate dehydrogenase (pLDH) antigen. However, Pf/Pan RDTs do not directly quantify parasitaemia. In this study, the diagnostic performance of Pf/Pan RDT and its association with parasite density was examined. Methods: Blood smears from patients who were screened for PRIMA Clinical Trial (Trial Registration Number: NCT03916003) conducted in East Sumba, Indonesia, and enrolled to its sub-study, ACROSS, were examined for microscopic examination and RDT using CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo (CareStart™ Pf/Pan RDT). Results were analysed for both diagnostic performance of RDT and its relationship with parasite density using a logistic regression model. Results: 317 participants were included in this study and 158 (49.8%) were malaria positive by microscopy. Among all malaria-positive participants, Plasmodium falciparum infections accounted for 149 (94.3%) cases. The sensitivity and specificity of HRP2 band were 97.3% (95% CI 93.3–99.2) and 97.6% (95% CI 94.0–99.4), respectively, while that of pLDH band were 87.3% (95% CI 81.1–92.0) and 100% (95% CI 97.7–100). For each ten-fold increase in parasite density, the RDT had 12 times the odds of returning Pf/Pan-positive results (n = 126) compared to Pf-positive (n = 19) (OR: 12.1; 95% CI 5.18 to 34.8; p < 0.001). Conclusions: CareStart™ Pf/Pan RDT is reliable in diagnosing falciparum malaria and Pf/Pan-positive results indicate higher parasite density. Pf/Pan-positive results should alert the clinical staff of the increased risk of poor clinical outcome, and should be prioritized for microscopic examination compared to Pf-positive results.

KW - CareStart Malaria HRP2/pLDH(Pf/PAN) Combo

KW - HRP2

KW - Malaria diagnosis

KW - Parasitaemia

KW - Parasite density

KW - Pf/Pan

KW - Plasmodium falciparum malaria

KW - PLDH

KW - Rapid diagnostic test

KW - RDT

UR - http://www.scopus.com/inward/record.url?scp=85218225687&partnerID=8YFLogxK

U2 - 10.1186/s12936-025-05276-y

DO - 10.1186/s12936-025-05276-y

M3 - Article

C2 - 39930468

AN - SCOPUS:85218225687

SN - 1475-2875

VL - 24

SP - 1

EP - 11

JO - Malaria Journal

JF - Malaria Journal

IS - 1

M1 - 39

ER -

Evaluation of CareStart™ malaria HRP2/pLDH (Pf/PAN) combo rapid diagnostic test for diagnosis of Plasmodium falciparum infection in malaria co-endemic areas in association with parasite density

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