HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.

<h4>Background</h4>Intermittent screening and treatment (IST) of malaria during pregnancy has been proposed as an alternative to intermittent preventive treatment in pregnancy (IPTp), where IPTp is failing due to drug resistance. However, the antenatal parasitaemias are frequently very l...

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Main Authors: Daniel J Kyabayinze, Issaka Zongo, Jane Cunningham, Michelle Gatton, Patrick Angutoko, John Ategeka, Yves-Daniel Compaoré, Atis Muehlenbachs, Jerry Mulondo, Miriam Nakalembe, Fabrice A Somé, Aminata Ouattara, Noél Rouamba, Jean-Bosco Ouédraogo, Heidi Hopkins, David Bell
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0156954&type=printable
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author Daniel J Kyabayinze
Issaka Zongo
Jane Cunningham
Michelle Gatton
Patrick Angutoko
John Ategeka
Yves-Daniel Compaoré
Atis Muehlenbachs
Jerry Mulondo
Miriam Nakalembe
Fabrice A Somé
Aminata Ouattara
Noél Rouamba
Jean-Bosco Ouédraogo
Heidi Hopkins
David Bell
author_facet Daniel J Kyabayinze
Issaka Zongo
Jane Cunningham
Michelle Gatton
Patrick Angutoko
John Ategeka
Yves-Daniel Compaoré
Atis Muehlenbachs
Jerry Mulondo
Miriam Nakalembe
Fabrice A Somé
Aminata Ouattara
Noél Rouamba
Jean-Bosco Ouédraogo
Heidi Hopkins
David Bell
author_sort Daniel J Kyabayinze
collection DOAJ
description <h4>Background</h4>Intermittent screening and treatment (IST) of malaria during pregnancy has been proposed as an alternative to intermittent preventive treatment in pregnancy (IPTp), where IPTp is failing due to drug resistance. However, the antenatal parasitaemias are frequently very low, and the most appropriate screening test for IST has not been defined.<h4>Methodology/principal findings</h4>We conducted a multi-center prospective study of 990 HIV-uninfected women attending ANC in two different malaria transmission settings at Tororo District Hospital, eastern Uganda and Colsama Health Center in western Burkina Faso. Women were enrolled in the study in the second or third trimester of pregnancy and followed to delivery, generating 2,597 blood samples for analysis. Screening tests included rapid diagnostic tests (RDTs) targeting histidine-rich protein 2 (HRP2) and parasite lactate dehydrogenase (pLDH) and microscopy, compared to nPCR as a reference standard. At enrolment, the proportion of pregnant women who were positive for P. falciparum by HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT, microscopy and PCR was 38%, 29%, 36% and 44% in Uganda and 21%, 16%, 15% and 35% in Burkina Faso, respectively. All test positivity rates declined during follow-up. In comparison to PCR, the sensitivity of the HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT and microscopy was 75.7%, 60.1% and 69.7% in Uganda, 55.8%, 42.6% and 55.8% in Burkina Faso respectively for all antenatal visits. Specificity was greater than 96% for all three tests. Comparison of accuracy using generalized estimating equation revealed that the HRP2- detecting RDT was the most accurate test in both settings.<h4>Conclusions/significance</h4>The study suggests that HRP2-based RDTs are the most appropriate point-of-care test currently available for use during pregnancy especially for symptomatic women, but will still miss some PCR-positive women. The clinical significance of these very low density infections needs to be better defined.
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spelling doaj-art-b70852de234a443bbc5ccbbf30615c2a2025-08-20T03:26:20ZengPublic Library of Science (PLoS)PLoS ONE1932-62032016-01-01117e015695410.1371/journal.pone.0156954HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.Daniel J KyabayinzeIssaka ZongoJane CunninghamMichelle GattonPatrick AngutokoJohn AtegekaYves-Daniel CompaoréAtis MuehlenbachsJerry MulondoMiriam NakalembeFabrice A SoméAminata OuattaraNoél RouambaJean-Bosco OuédraogoHeidi HopkinsDavid Bell<h4>Background</h4>Intermittent screening and treatment (IST) of malaria during pregnancy has been proposed as an alternative to intermittent preventive treatment in pregnancy (IPTp), where IPTp is failing due to drug resistance. However, the antenatal parasitaemias are frequently very low, and the most appropriate screening test for IST has not been defined.<h4>Methodology/principal findings</h4>We conducted a multi-center prospective study of 990 HIV-uninfected women attending ANC in two different malaria transmission settings at Tororo District Hospital, eastern Uganda and Colsama Health Center in western Burkina Faso. Women were enrolled in the study in the second or third trimester of pregnancy and followed to delivery, generating 2,597 blood samples for analysis. Screening tests included rapid diagnostic tests (RDTs) targeting histidine-rich protein 2 (HRP2) and parasite lactate dehydrogenase (pLDH) and microscopy, compared to nPCR as a reference standard. At enrolment, the proportion of pregnant women who were positive for P. falciparum by HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT, microscopy and PCR was 38%, 29%, 36% and 44% in Uganda and 21%, 16%, 15% and 35% in Burkina Faso, respectively. All test positivity rates declined during follow-up. In comparison to PCR, the sensitivity of the HRP2/pan pLDH RDT, Pf pLDH/pan pLDH RDT and microscopy was 75.7%, 60.1% and 69.7% in Uganda, 55.8%, 42.6% and 55.8% in Burkina Faso respectively for all antenatal visits. Specificity was greater than 96% for all three tests. Comparison of accuracy using generalized estimating equation revealed that the HRP2- detecting RDT was the most accurate test in both settings.<h4>Conclusions/significance</h4>The study suggests that HRP2-based RDTs are the most appropriate point-of-care test currently available for use during pregnancy especially for symptomatic women, but will still miss some PCR-positive women. The clinical significance of these very low density infections needs to be better defined.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0156954&type=printable
spellingShingle Daniel J Kyabayinze
Issaka Zongo
Jane Cunningham
Michelle Gatton
Patrick Angutoko
John Ategeka
Yves-Daniel Compaoré
Atis Muehlenbachs
Jerry Mulondo
Miriam Nakalembe
Fabrice A Somé
Aminata Ouattara
Noél Rouamba
Jean-Bosco Ouédraogo
Heidi Hopkins
David Bell
HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
PLoS ONE
title HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
title_full HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
title_fullStr HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
title_full_unstemmed HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
title_short HRP2 and pLDH-Based Rapid Diagnostic Tests, Expert Microscopy, and PCR for Detection of Malaria Infection during Pregnancy and at Delivery in Areas of Varied Transmission: A Prospective Cohort Study in Burkina Faso and Uganda.
title_sort hrp2 and pldh based rapid diagnostic tests expert microscopy and pcr for detection of malaria infection during pregnancy and at delivery in areas of varied transmission a prospective cohort study in burkina faso and uganda
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0156954&type=printable
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