Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger
Abstract Background Rapid diagnostic tests (RDT) for malaria are common, but their performance varies. Tests using histidine-rich protein 2 (HRP2) antigen are most common, and many have high sensitivity. HRP2 tests can remain positive for weeks after treatment, limiting their specificity and usefuln...
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doaj-b38924b97ce04585873f409ef6eb53962020-12-27T12:19:56ZengBMCMalaria Journal1475-28752019-12-0118111110.1186/s12936-019-3079-1Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in NigerMatthew E. Coldiron0Bachir Assao1Céline Langendorf2Nathan Sayinzoga-Makombe3Iza Ciglenecki4Roberto de la Tour5Erwan Piriou6Mahaman Yarima Bako7Ann Mumina8Ousmane Guindo9Anne-Laure Page10Rebecca F. Grais11EpicentreEpicentreEpicentreEpicentreMédecins Sans FrontièresMédecins Sans FrontièresMédecins Sans FrontièresMinistry of Public HealthMédecins Sans FrontièresEpicentreEpicentreEpicentreAbstract Background Rapid diagnostic tests (RDT) for malaria are common, but their performance varies. Tests using histidine-rich protein 2 (HRP2) antigen are most common, and many have high sensitivity. HRP2 tests can remain positive for weeks after treatment, limiting their specificity and usefulness in high-transmission settings. Tests using Plasmodium lactate dehydrogenase (pLDH) have been less widely used but have higher specificity, mostly due to a much shorter time to become negative. Methods A prospective, health centre-based, diagnostic evaluation of two malaria RDTs was performed in rural Niger during the high malaria transmission season (3–28 October, 2017) and during the low transmission season (28 January–31 March, 2018). All children under 5 years of age presenting with fever (axillary temperature > 37.5 °C) or history of fever in the previous 24 h were eligible. Capillary blood was collected by finger prick. The SD Bioline HRP2 (catalog: 05FK50) and the CareStart pLDH(pan) (catalog: RMNM-02571) were performed in parallel, and thick and thin smears were prepared. Microscopy was performed at Epicentre, Maradi, Niger, with external quality control. The target sample size was 279 children with microscopy-confirmed malaria during each transmission season. Results In the high season, the sensitivity of both tests was estimated at > 99%, but the specificity of both tests was lower: 58.0% (95% CI 52.1–63.8) for the pLDH test and 57.4% (95% CI 51.5–63.1) for the HRP2 test. The positive predictive value was 66.3% (95% CI 61.1–71.2) for both tests. In the low season, the sensitivity of both tests dropped: 91.0% (95% CI 85.3–95.0) for the pLDH test and 85.8% (95% CI 79.3–90.9) for the HRP2 test. The positive predictive value remained low for both tests in the low season: 60.5% (95% CI 53.9–66.8) for the pLDH test and 61.9% (55.0–68.4) for the HRP2 test. Performance was similar across different production lots, gender, age of the children, and, during the high season, time since the most recent distribution of seasonal malaria chemoprevention. Conclusions The low specificity of the pLDH RDT in this setting was unexpected and is not easily explained. As the pLDH test continues to be introduced into new settings, the questions raised by this study will need to be addressed.https://doi.org/10.1186/s12936-019-3079-1MalariaRapid diagnostic testPlasmodium lactate dehydrogenaseHistidine-rich protein 2Niger |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Matthew E. Coldiron Bachir Assao Céline Langendorf Nathan Sayinzoga-Makombe Iza Ciglenecki Roberto de la Tour Erwan Piriou Mahaman Yarima Bako Ann Mumina Ousmane Guindo Anne-Laure Page Rebecca F. Grais |
spellingShingle |
Matthew E. Coldiron Bachir Assao Céline Langendorf Nathan Sayinzoga-Makombe Iza Ciglenecki Roberto de la Tour Erwan Piriou Mahaman Yarima Bako Ann Mumina Ousmane Guindo Anne-Laure Page Rebecca F. Grais Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger Malaria Journal Malaria Rapid diagnostic test Plasmodium lactate dehydrogenase Histidine-rich protein 2 Niger |
author_facet |
Matthew E. Coldiron Bachir Assao Céline Langendorf Nathan Sayinzoga-Makombe Iza Ciglenecki Roberto de la Tour Erwan Piriou Mahaman Yarima Bako Ann Mumina Ousmane Guindo Anne-Laure Page Rebecca F. Grais |
author_sort |
Matthew E. Coldiron |
title |
Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger |
title_short |
Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger |
title_full |
Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger |
title_fullStr |
Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger |
title_full_unstemmed |
Clinical diagnostic evaluation of HRP2 and pLDH-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in Niger |
title_sort |
clinical diagnostic evaluation of hrp2 and pldh-based rapid diagnostic tests for malaria in an area receiving seasonal malaria chemoprevention in niger |
publisher |
BMC |
series |
Malaria Journal |
issn |
1475-2875 |
publishDate |
2019-12-01 |
description |
Abstract Background Rapid diagnostic tests (RDT) for malaria are common, but their performance varies. Tests using histidine-rich protein 2 (HRP2) antigen are most common, and many have high sensitivity. HRP2 tests can remain positive for weeks after treatment, limiting their specificity and usefulness in high-transmission settings. Tests using Plasmodium lactate dehydrogenase (pLDH) have been less widely used but have higher specificity, mostly due to a much shorter time to become negative. Methods A prospective, health centre-based, diagnostic evaluation of two malaria RDTs was performed in rural Niger during the high malaria transmission season (3–28 October, 2017) and during the low transmission season (28 January–31 March, 2018). All children under 5 years of age presenting with fever (axillary temperature > 37.5 °C) or history of fever in the previous 24 h were eligible. Capillary blood was collected by finger prick. The SD Bioline HRP2 (catalog: 05FK50) and the CareStart pLDH(pan) (catalog: RMNM-02571) were performed in parallel, and thick and thin smears were prepared. Microscopy was performed at Epicentre, Maradi, Niger, with external quality control. The target sample size was 279 children with microscopy-confirmed malaria during each transmission season. Results In the high season, the sensitivity of both tests was estimated at > 99%, but the specificity of both tests was lower: 58.0% (95% CI 52.1–63.8) for the pLDH test and 57.4% (95% CI 51.5–63.1) for the HRP2 test. The positive predictive value was 66.3% (95% CI 61.1–71.2) for both tests. In the low season, the sensitivity of both tests dropped: 91.0% (95% CI 85.3–95.0) for the pLDH test and 85.8% (95% CI 79.3–90.9) for the HRP2 test. The positive predictive value remained low for both tests in the low season: 60.5% (95% CI 53.9–66.8) for the pLDH test and 61.9% (55.0–68.4) for the HRP2 test. Performance was similar across different production lots, gender, age of the children, and, during the high season, time since the most recent distribution of seasonal malaria chemoprevention. Conclusions The low specificity of the pLDH RDT in this setting was unexpected and is not easily explained. As the pLDH test continues to be introduced into new settings, the questions raised by this study will need to be addressed. |
topic |
Malaria Rapid diagnostic test Plasmodium lactate dehydrogenase Histidine-rich protein 2 Niger |
url |
https://doi.org/10.1186/s12936-019-3079-1 |
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