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International journal of environmental research and public health 19(17), 10855 (2022). doi:10.3390/ijerph191710855 special issue: "Special Issue "Using Digital Health Technologies to Improve Healthcare Quality" / Special Issue Editors: Dr. Anna Janssen, Guest Editor; Dr. Melissa Brunner, Guest Editor", Published by MDPI, Basel

International journal of environmental research and public health 19(15), 9209 (2022). doi:10.3390/ijerph19159209 special issue: "Special Issue "Women's Gynecological and Reproductive Health—Issues and Challenges" / Special Issue Editor: Dr. Dell Horey, Guest Editor", Published by MDPI AG, Basel

Background Malaria diagnosis in many malaria-endemic countries relies mainly on the use of rapid diagnostic tests (RDTs). The majority of commercial RDTs used in Africa detect the Plasmodium falciparum histidine-rich protein 2 (PfHRP2). pfhrp2/3 gene deletions can therefore lead to false-negative RDT results. This study aimed to evaluate the frequency of PCR-confirmed, false-negative P. falciparum RDT results in Monrovia, Liberia. Methods PfHRP2-based RDT (Paracheck Pf®) and microscopy results from 1038 individuals with fever or history of fever (n = 951) and pregnant women at first antenatal care (ANC) visit (n = 87) enrolled in the Saint Joseph’s Catholic Hospital (Monrovia) from March to July 2019 were used to assess the frequency of false-negative RDT results. True–false negatives were confirmed by detecting the presence of P. falciparum DNA by quantitative PCR in samples from individuals with discrepant RDT and microscopy results. Samples that were positive by 18S rRNA qPCR but negative by PfHRP2-RDT were subjected to multiplex qPCR assay for detection of pfhrp2 and pfhrp3. Results One-hundred and eighty-six (19.6%) and 200 (21.0%) of the 951 febrile participants had a P. falciparum-positive result by RDT and microscopy, respectively. Positivity rate increased with age and the reporting of joint pain, chills and shivers, vomiting and weakness, and decreased with the presence of coughs and nausea. The positivity rate at first ANC visit was 5.7% (n = 5) and 8% (n = 7) by RDT and microscopy, respectively. Out of 207 Plasmodium infections detected by microscopy, 22 (11%) were negative by RDT. qPCR confirmed absence of P. falciparum DNA in the 16 RDT-negative but microscopy-positive samples which were available for molecular testing. Among the 14 samples that were positive by qPCR but negative by RDT and microscopy, 3 only amplified pfldh, and among these 3 all were positive for pfhrp2 and pfhrp3. Conclusion There is no qPCR-confirmed evidence of false-negative RDT results due to pfhrp2/pfhrp3 deletions in this study conducted in Monrovia (Liberia). This indicates that these deletions are not expected to affect the performance of PfHRP2-based RDTs for the diagnosis of malaria in Liberia. Nevertheless, active surveillance for the emergence of PfHRP2 deletions is required.

Ethical and effective data-sharing among countries can be achieved by considering the interests of all relevant parties: research participants, researchers and funders. Fears of exploitation, however, both of research participants and researchers from low- and middle-income countries (LMIC), can undermine the free flow of data necessary for scientific advancement. In this Open Letter, two case studies presented at the 2018 Global Forum on Bioethics in Research meeting on the Ethics of data sharing and biobanking in Cape Town, South Africa, function as the focal point for a reflection on the attributes of an ideal model of good data governance and how it can help support ethical best practices in biobanking and data sharing. Consideration of the case studies as well as the literature indicate three broad principles that need to be reflected in an ideal data governance framework: (i) collaboration - both among researchers as well as between researchers and participants, (ii) fairness – ensuring that all parties in international collaborations, the data provider, primary data gathering LMIC researcher and the high income country (HIC) institution/funder are treated fairly, and (iii) working towards a level playing field – neither collaboration nor fairness can be effectively achieved with the existing power differential between HIC and LMIC researchers/institutions; it is therefore necessary to work towards achieving a more level playing field between partners in research collaborations. Promoting good governance of data through fair, efficient and accountable governance frameworks can help build trust and ensure continued international data sharing.