Clinical Utility of Monobiomaker-Based Malaria Rapid Diagnostic Test Kits at a Military Medical Centre in Ghana: An Exploration Pilot Study

Author:

Hamid Abdul-Wahab Mawuko1ORCID,Yovelanywe Suonyir Raymond2ORCID,Frimpomaa Salomey3ORCID,Agyeman-Duah Kwaku4ORCID,Kissiedu Kwapong Yaw4ORCID,Cudjoe Evans Ewusie4ORCID,Akoliga Samuel3ORCID,Kinanyok Silas3ORCID,Kwadzokpui Precious Kwablah5ORCID,Jnr Kenneth Owusu Agyemang6ORCID,Duneeh Richard Vikpebah3ORCID,Bawah Ahmed Tijani7ORCID,Nanga Salifu8ORCID,Saeed Sumaiya Salifu9ORCID,Boakye-Yiadom Emily10ORCID,Afeke Innocent11ORCID,Orish Verner Ndudiri12ORCID,Kasu Emmanuel Senyo13,Ofori Eric Kwasi14,Owusu-Agyei Seth15ORCID

Affiliation:

1. University of Health and Allied Sciences

2. Department of Laboratory Sciences, School of Allied Health Sciences, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

3. Department of Medical Laboratory Sciences, School of Allied Health Sciences, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

4. 7 Medical Reception Station, 66 Artillery Regiment, PO Box 89 Ho, Volta Region, Ghana.

5. Clinical Laboratory of Ho Teaching Hospital, Sciences, PMB 31, Ho, Volta Region, Ghana

6. Akatsi Municipal Hospital, Agbalixorme on Tadzewu-Akatsi RD, Box Ak83.Akatsi, Volta Region, Ghana.

7. Faculty of Allied Health and Pharmaceutical Sciences, Tamale Technical University, P.O. Box 3E/R, Tamale, Ghana

8. School of Basic and Biomedical Sciences, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

9. Public Affairs Directorate, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.0-0002-1672-7920

10. Department of Microbiology & Immunology, School of Medicine, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

11. Department of Laboratory Sciences, School of Allied Health Sciences, University of Health and Allied Sciences, PMB 31, Ho , Volta Region, Ghana.

12. Department of Microbiology & Immunology, School of Medicine, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana. s://orcid.org/0000-0002-8345-423X

13. School of Public Health, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

14. Directorate, School of Allied Health Sciences, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana.

15. Institute of Health Research, University of Health and Allied Sciences, PMB 31, Ho, Volta Region, Ghana

Abstract

Abstract Background: Proliferation of non-falciparum species of plasmodium into predominant falciparum populations compromises the utility of monobiomaker based malaria Rapid Diagnostic Test (mRDT). This study evaluated the validity of a mono-biomarker based Carestart®) and Paracheck™ mRDTs in use at a Military Medical Centre in Ghana. Methodology: The study was designed to assess the validity of named mRDTs in a setting in Ghana. Blood samples collected from a consecutive series of 207 febrile patients in the months of June and July 2020, were tested for malaria parasites, using the mRDTs and microscopy as the gold standard. Prevalence, validity, and reliability metrics were determined using Frequentist, Receiver Operating Characteristics (ROC), and Kappa statistics, respectively. Results: The prevalence was 23.2% and 12.3% using microscopy and candidate mRDT, respectively. Sensitivities and specificities were 53.2% and 98.1% (Carestart®), 45.8% and 99.4% (Paracheck), respectively. Neither ROC analysis showed a significant disparity between mRDTs (Carestart®: AUROC=0.75 vs Paracheck™: AUROC=0.73), nor the reliability index showed disagreement between both mRDTs (Cronbach’s α = 0.92). But there was significant disagreement between microscopy and mRDTs (Carestart®: Kappa=0.58 vs Paracheck™: Kappa=0.55). Conclusion: The use of a monobiomaker mRDTs in this study led to a significant variation between the ‘internal’ and ‘ecological’ validity metrics. Averagely, 84% mRDT false negatives was non-falciparum. It is therefore, critical to accelerate the implementation of WHO’s recommendation to switch from mono to multiple biomarker (s)-based mRDTs for detecting both falciparum and non-falciparum species. Extended research is needed to consolidate our understanding of the dynamics of malaria among our military personnel exposed to non-falciparum plasmodium.

Publisher

Research Square Platform LLC

Reference57 articles.

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3. Rowe AK. Assessing the Health Impact of Malaria Control Interventions in the MDG/Sustainable Development Goal Era: A New Generation of Impact Evaluations. Am J Trop Med Hyg. 2017 Sep 27;97(3 Suppl):6–8.

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