Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon

Background: There was an increase in the number of malaria cases in Cameroon in 2018 that could reflect changes in provider practice, despite effective interventions. In this study, we assessed the diagnostic performance of two malaria rapid diagnostic tests (mRDTs) for diagnostic confirmation of su...

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Main Authors: Innocent Mbulli Ali, Akindeh Mbuh Nji, Jacob Chefor Bonkum, Marcel Nyuylam Moyeh, Guenang Kenfack Carole, Agni Efon, Solange Dabou, Valery Pacome Kom Tchuenkam, Calvino Tah, Jean-Paul Chedjou Kengne, Dorothy Fosah Achu, Jude Daiga Bigoga, Wilfred Fon Mbacham
Format: Article
Language:English
Published: MDPI AG 2021-08-01
Series:Diagnostics
Subjects:
Online Access:https://www.mdpi.com/2075-4418/11/9/1556
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author Innocent Mbulli Ali
Akindeh Mbuh Nji
Jacob Chefor Bonkum
Marcel Nyuylam Moyeh
Guenang Kenfack Carole
Agni Efon
Solange Dabou
Valery Pacome Kom Tchuenkam
Calvino Tah
Jean-Paul Chedjou Kengne
Dorothy Fosah Achu
Jude Daiga Bigoga
Wilfred Fon Mbacham
author_facet Innocent Mbulli Ali
Akindeh Mbuh Nji
Jacob Chefor Bonkum
Marcel Nyuylam Moyeh
Guenang Kenfack Carole
Agni Efon
Solange Dabou
Valery Pacome Kom Tchuenkam
Calvino Tah
Jean-Paul Chedjou Kengne
Dorothy Fosah Achu
Jude Daiga Bigoga
Wilfred Fon Mbacham
author_sort Innocent Mbulli Ali
collection DOAJ
description Background: There was an increase in the number of malaria cases in Cameroon in 2018 that could reflect changes in provider practice, despite effective interventions. In this study, we assessed the diagnostic performance of two malaria rapid diagnostic tests (mRDTs) for diagnostic confirmation of suspected cases of malaria in public and private health facilities in two malaria transmission settings in Cameroon. Methods: We evaluated the diagnostic performance of CareStart pf and SD Bioline Pf/PAN mRDT and compared these parameters by RDT type and transmission setting. Nested PCR and blood film microscopy were used as references. The chi square test was used for independent sample comparisons, while the McNemar’s test was used to test for the dependence of categorical data in paired sample testing. A <i>p</i> < 0.05 was considered significant in all comparisons. The R (v.4.0.2) software was used for analyses. Results: A total of 1126 participants consented for the study in the four sites. The diagnostic accuracy of the CareStart Pf mRDT was 0.93.6% (0.911–0.961) in Yaoundé, 0.930% (0.90–0.960) in Ngounso, 0.84% (0.794–0.891) in St Vincent Catholic Hospital Dschang and 0.407 (0.345–0.468) in Dschang district hospital. For SD Bioline Pf/PAN the accuracy was 0.759 (0.738–0.846) for St Vincent Catholic Hospital Dschang and 0.426 (0.372–0.496) for the Dschang district hospital. The accuracy was slightly lower in each case but not statistically different when PCR was considered as the reference. The likelihood ratios of the positive and negative tests were high in the high transmission settings of Yaoundé (10.99 (6.24–19.35)) and Ngounso (14.40 (7.89–26.28)) compared to the low transmission settings of Dschang (0.71 (0.37–1.37)) and St Vincent Catholic hospital (7.37 (4.32−12.59)). There was a high degree of agreement between the tests in Yaoundé (Cohen’s Kappa: 0.85 ± 0.05 (0.7–0.95)) and Ngounso (Cohen’s Kappa: 0.86 ± 0.05 (0.74, 0.97)) and moderate agreement in St Vincent hospital Dschang (k: 0.58 ± 0.06 (0.44–0.71)) and poor agreement in the District Hospital Dschang (Cohen’s Kappa: −0.11 ± 0.05 (−0.21–0.01)). The diagnostic indicators of the SD Bioline Pf/PAN were slightly better than for CareStart Pf mRDT in St Vincent Catholic hospital Dschang, irrespective of the reference test. Conclusions: Publicly procured malaria rapid diagnostic tests in Cameroon have maintained high accuracy (91–94%) in the clinical diagnosis of malaria in high malaria transmission regions of Cameroon, although they failed to reach WHO standards. We observed an exception in the low transmission region of Dschang, West region, where the accuracy tended to be lower and variable between facilities located in this town. These results underscore the importance of the routine monitoring of the quality and performance of malaria RDTs in diverse settings in malaria endemic areas.
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spelling doaj.art-bac00c9e381f40198a49a56fc3c345f92023-11-22T12:38:41ZengMDPI AGDiagnostics2075-44182021-08-01119155610.3390/diagnostics11091556Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in CameroonInnocent Mbulli Ali0Akindeh Mbuh Nji1Jacob Chefor Bonkum2Marcel Nyuylam Moyeh3Guenang Kenfack Carole4Agni Efon5Solange Dabou6Valery Pacome Kom Tchuenkam7Calvino Tah8Jean-Paul Chedjou Kengne9Dorothy Fosah Achu10Jude Daiga Bigoga11Wilfred Fon Mbacham12The Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonDepartment of Animal Biology, Faculty of Science, University of Dschang, Dschang BP 67, West Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonDepartment of Biochemistry, Faculty of Science, University of Dschang, Dschang BP 67, West Region, CameroonDepartment of Biochemistry, Faculty of Science, University of Dschang, Dschang BP 67, West Region, CameroonDepartment of Biochemistry, Faculty of Science, University of Dschang, Dschang BP 67, West Region, CameroonDepartment of Biochemistry, Faculty of Science, University of Dschang, Dschang BP 67, West Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonNational Malaria Control Program, Ministry of Public Health, Yaoundé BP 14386, Centre Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonThe Biotechnology Centre, University of Yaoundé 1, Yaoundé BP 8094, Centre Region, CameroonBackground: There was an increase in the number of malaria cases in Cameroon in 2018 that could reflect changes in provider practice, despite effective interventions. In this study, we assessed the diagnostic performance of two malaria rapid diagnostic tests (mRDTs) for diagnostic confirmation of suspected cases of malaria in public and private health facilities in two malaria transmission settings in Cameroon. Methods: We evaluated the diagnostic performance of CareStart pf and SD Bioline Pf/PAN mRDT and compared these parameters by RDT type and transmission setting. Nested PCR and blood film microscopy were used as references. The chi square test was used for independent sample comparisons, while the McNemar’s test was used to test for the dependence of categorical data in paired sample testing. A <i>p</i> < 0.05 was considered significant in all comparisons. The R (v.4.0.2) software was used for analyses. Results: A total of 1126 participants consented for the study in the four sites. The diagnostic accuracy of the CareStart Pf mRDT was 0.93.6% (0.911–0.961) in Yaoundé, 0.930% (0.90–0.960) in Ngounso, 0.84% (0.794–0.891) in St Vincent Catholic Hospital Dschang and 0.407 (0.345–0.468) in Dschang district hospital. For SD Bioline Pf/PAN the accuracy was 0.759 (0.738–0.846) for St Vincent Catholic Hospital Dschang and 0.426 (0.372–0.496) for the Dschang district hospital. The accuracy was slightly lower in each case but not statistically different when PCR was considered as the reference. The likelihood ratios of the positive and negative tests were high in the high transmission settings of Yaoundé (10.99 (6.24–19.35)) and Ngounso (14.40 (7.89–26.28)) compared to the low transmission settings of Dschang (0.71 (0.37–1.37)) and St Vincent Catholic hospital (7.37 (4.32−12.59)). There was a high degree of agreement between the tests in Yaoundé (Cohen’s Kappa: 0.85 ± 0.05 (0.7–0.95)) and Ngounso (Cohen’s Kappa: 0.86 ± 0.05 (0.74, 0.97)) and moderate agreement in St Vincent hospital Dschang (k: 0.58 ± 0.06 (0.44–0.71)) and poor agreement in the District Hospital Dschang (Cohen’s Kappa: −0.11 ± 0.05 (−0.21–0.01)). The diagnostic indicators of the SD Bioline Pf/PAN were slightly better than for CareStart Pf mRDT in St Vincent Catholic hospital Dschang, irrespective of the reference test. Conclusions: Publicly procured malaria rapid diagnostic tests in Cameroon have maintained high accuracy (91–94%) in the clinical diagnosis of malaria in high malaria transmission regions of Cameroon, although they failed to reach WHO standards. We observed an exception in the low transmission region of Dschang, West region, where the accuracy tended to be lower and variable between facilities located in this town. These results underscore the importance of the routine monitoring of the quality and performance of malaria RDTs in diverse settings in malaria endemic areas.https://www.mdpi.com/2075-4418/11/9/1556malariarapid diagnostic testHistidine-rich proteinsensitivityCareStartSD Bioline
spellingShingle Innocent Mbulli Ali
Akindeh Mbuh Nji
Jacob Chefor Bonkum
Marcel Nyuylam Moyeh
Guenang Kenfack Carole
Agni Efon
Solange Dabou
Valery Pacome Kom Tchuenkam
Calvino Tah
Jean-Paul Chedjou Kengne
Dorothy Fosah Achu
Jude Daiga Bigoga
Wilfred Fon Mbacham
Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
Diagnostics
malaria
rapid diagnostic test
Histidine-rich protein
sensitivity
CareStart
SD Bioline
title Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
title_full Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
title_fullStr Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
title_full_unstemmed Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
title_short Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon
title_sort diagnostic accuracy of carestart™ malaria hrp2 and sd bioline pf pan for malaria in febrile outpatients in varying malaria transmission settings in cameroon
topic malaria
rapid diagnostic test
Histidine-rich protein
sensitivity
CareStart
SD Bioline
url https://www.mdpi.com/2075-4418/11/9/1556
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