Lessons from the pandemic: new best practices in selecting molecular diagnostics for point-of-care testing of infectious diseases in sub-Saharan Africa

References

• GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the global burden of disease study 2019. Lancet. 2020;396(10258):1204–1222. doi: 10.1016/S0140-6736(20)30925-9
   PubMed Web of Science ®Google Scholar
• Nkengasong JN, Tessema SK. Africa needs a new public Health order to tackle infectious disease threats. Cell. 2020;183(2):296–300. doi:10.1016/j.cell.2020.09.041
   PubMed Web of Science ®Google Scholar
• Fleming KA, Horton S, Wilson ML, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet. 2021;398(10315):1997–2050. doi: 10.1016/S0140-6736(21)00673-5
   PubMed Web of Science ®Google Scholar
• Kobia F, Gitaka J. COVID-19: Are Africa’s diagnostic challenges blunting response effectiveness? AAS Open Res. 2020;3(4):4. doi: 10.12688/aasopenres.13061.1
   PubMedGoogle Scholar
• World Health Organization. Global strategy on human resources for health: workforce 2030. World Health Org. 2016
   Google Scholar
• Jacobs J, Kuhne V, Lunguya O, et al. Implementing COVID-19 (SARS-CoV-2) rapid diagnostic tests in sub-Saharan Africa: a review. Front Med. 2020;7:557797. doi: 10.3389/fmed.2020.557797
   Web of Science ®Google Scholar
• Digital Diagnostics for Africa Network. The potential of digital molecular diagnostics for infectious diseases in sub-Saharan Africa. PLOS Digit Health. 2022;1(6):e0000064. doi: 10.1371/journal.pdig.0000064
   PubMedGoogle Scholar
• Land KJ, Boeras DI, Chen XS, et al. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nat Microbiol. 2019;4(1):46–54. doi: 10.1038/s41564-018-0295-3
   PubMed Web of Science ®Google Scholar
• Moetlhoa B, Maluleke K, Mathebula EM, et al. REASSURED diagnostics at point-of-care in sub-Saharan Africa: A scoping review. PLOS Glob Public Health. 2023;3(6):e0001443. doi: 10.1371/journal.pgph.0001443
   PubMedGoogle Scholar
• Margolin E, Burgers WA, Sturrock ED, et al. Prospects for SARS-CoV-2 diagnostics, therapeutics and vaccines in Africa. Nat Rev Microbiol. 2020;18(12):690–704. doi: 10.1038/s41579-020-00441-3
   PubMed Web of Science ®Google Scholar
• Vandenberg O, Martiny D, Rochas O, et al. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol. 2021;19(3):171–183. doi: 10.1038/s41579-020-00461-z
   PubMed Web of Science ®Google Scholar
• Baldanti F, Ganguly NK, Wang G, et al. Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future. Crit Rev Clin Lab Sci. 2022;59(7):445–459. doi: 10.1080/10408363.2022.2045250
   PubMed Web of Science ®Google Scholar
• Yusuf L, Appeaning M, Amole TG, et al. Rapid, cheap, and effective COVID-19 diagnostics for Africa. Diagnostics. 2021;11(11):2105. doi: 10.3390/diagnostics11112105
   Web of Science ®Google Scholar
• Hosseinifard M, Naghdi T, Morales-Narvaez E, et al. Toward smart diagnostics in a pandemic scenario: COVID-19. Front Bioeng Biotechnol. 2021;9:637203. doi: 10.3389/fbioe.2021.637203
   PubMed Web of Science ®Google Scholar
• Sachdeva S, Davis RW, Saha AK. Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions. Front Bioeng Biotechnol. 2020;8:602659. doi:10.3389/fbioe.2020.602659
   PubMed Web of Science ®Google Scholar
• Heidt B, Siqueira WF, Eersels K, et al. Point of care diagnostics in resource-limited settings: a review of the present and future of PoC in its most needed environment. Biosensors (Basel). 2020;10(10):133. doi: 10.3390/bios10100133
   PubMedGoogle Scholar
• Kost GJ. The coronavirus disease 2019 spatial care path: home, community, and emergency diagnostic portals. Diagnostics. 2022;12(5):1216. doi:10.3390/diagnostics12051216
   Web of Science ®Google Scholar
• Reynard C, Allen JA, Shinkins B, et al. COVID-19 rapid diagnostics: practice review. Emerg Med J. 2022;39(1):70–76. doi: 10.1136/emermed-2021-211814
   PubMed Web of Science ®Google Scholar
• Smith E, Zhen W, Manji R, et al. Analytical and clinical comparison of three nucleic acid amplification tests for SARS-CoV-2 detection. J Clin Microbiol. 2020;58(9):e01134–20. doi: 10.1128/JCM.01134-20
   PubMed Web of Science ®Google Scholar
• Zhen W, Smith E, Manji R, et al. Clinical evaluation of three sample-to-answer platforms for detection of SARS-CoV-2. J Clin Microbiol. 2020;58(8):e00783–20. doi: 10.1128/JCM.00783-20
   PubMed Web of Science ®Google Scholar
• Gibani MM, Toumazou C, Sohbati M, et al. Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study. Lancet Microbe. 2020;1(7):e300–e7. doi: 10.1016/S2666-5247(20)30121-X
   PubMedGoogle Scholar
• https://www.protondx.com/dragonfly cited 28 Aug 2023.
   Google Scholar
• Africa Centres for Disease Control and Prevention. Building testing capacity for epidemic-prone diseases. Guidance to African Union member states. Addis Ababa, Ethiopia: Africa Centres for Disease Control and Prevention; 2023.
   Google Scholar
• Hicks T, Winter A, Green K, et al. Care pathway and prioritization of rapid testing for COVID-19 in UK hospitals: a qualitative evaluation. BMC Health Serv Res. 2021;21(1):532. doi: 10.1186/s12913-021-06460-x
   PubMed Web of Science ®Google Scholar
• Yau F, Ferreira R, Kamali R, et al. Clinical utility of a rapid ‘on-demand’ laboratory-based SARS-CoV-2 diagnostic testing service in an acute hospital setting admitting COVID-19 patients. Clin Infect Pract. 2021;12:100086. doi: 10.1016/j.clinpr.2021.100086
   PubMedGoogle Scholar
• Mardian Y, Kosasih H, Karyana M, et al. Review of Current COVID-19 diagnostics and opportunities for further development. Front Med. 2021;8:615099. doi: 10.3389/fmed.2021.615099
   PubMed Web of Science ®Google Scholar
• Gupta N, Rana S, Singh H. Innovative point-of-care molecular diagnostic test for COVID-19 in India. Lancet Microbe. 2020;1(7):e277. doi:10.1016/S2666-5247(20)30164-6
   PubMedGoogle Scholar
• Rakotosamimanana N, Randrianirina F, Randremanana R, et al. GeneXpert for the diagnosis of COVID-19 in LMICs. Lancet Glob Health. 2020;8(12):e1457–e8. doi: 10.1016/S2214-109X(20)30428-9
   PubMed Web of Science ®Google Scholar
• Affara M, Lagu HI, Achol E, et al. The East African Community (EAC) mobile laboratory networks in Kenya, Burundi, Tanzania, Rwanda, Uganda, and South Sudan-from project implementation to outbreak response against dengue, ebola, COVID-19, and epidemic-prone diseases. BMC Med. 2021;19(1):160. doi: 10.1186/s12916-021-02028-y
   PubMed Web of Science ®Google Scholar
• Prazuck T, Gravier A, Pires-Roteira D, et al. Evaluation of a new “all in one” SARS-CoV-2 antigen-detecting rapid diagnostic test and self-test: diagnostic performance and usability in child and adult populations. J Med Virol. 2022;94(9):4097–4106. doi: 10.1002/jmv.27812
   PubMed Web of Science ®Google Scholar
• Prado NO, Lalli LA, Blanes L, et al. Lyophilization of molecular biology reactions: a review. Mini Rev Med Chem. 2023;23(4):480–496. doi: 10.2174/1389557522666220802144057
   PubMed Web of Science ®Google Scholar
• Johnson G, Zubrzycki A, Henry M, et al. Clinical evaluation of the GeneXpert(R) Xpert(R) xpress SARS-CoV-2/Flu/RSV combination test. J Clin Virol Plus. 2021;1(1):100014. doi: 10.1016/j.jcvp.2021.100014
   PubMedGoogle Scholar
• Umubyeyi Nyaruhirira A, Scholten JN, Gidado M, et al. Coronavirus disease 2019 diagnosis in low- and middle-income countries: the big new bully disrupting TB and HIV diagnostic services. J Mol Diagn. 2022;24(4):289–293. doi: 10.1016/j.jmoldx.2021.12.008
   PubMed Web of Science ®Google Scholar
• Das S, Dunbar S. The COVID-19 pandemic - a diagnostic industry perspective. Front Cell Infect Microbiol. 2022;12:862440.
   PubMed Web of Science ®Google Scholar
• Adepoju P. Africa’s struggle with inadequate COVID-19 testing. Lancet Microbe. 2020;1(1):e12. doi:10.1016/S2666-5247(20)30014-8
   PubMedGoogle Scholar
• Chong YP, Choy KW, Doerig C, et al. SARS-CoV-2 testing strategies in the diagnosis and management of COVID-19 patients in low-income countries: a scoping review. Mol Diagn Ther. 2023;27(3):303–320. doi: 10.1007/s40291-022-00637-8
   PubMed Web of Science ®Google Scholar
• Gartner K, Meleke H, Kamdolozi M, et al. A fast extraction-free isothermal LAMP assay for detection of SARS-CoV-2 with potential use in resource-limited settings. Virol J. 2022;19(1):77. doi: 10.1186/s12985-022-01800-7
   PubMed Web of Science ®Google Scholar
• Manjate NJ, Sitoe N, Sambo J, et al. Testing for SARS-CoV-2 in resource-limited settings: a cost analysis study of diagnostic tests using different Ag-RDTs and RT-PCR technologies in Mozambique. PLOS Glob Public Health. 2023;3(6):e0001999. doi: 10.1371/journal.pgph.0001999
   PubMedGoogle Scholar
• Elvidge J, Summerfield A, Nicholls D, et al. Diagnostics and treatments of COVID-19: a living systematic review of economic evaluations. Value Health. 2022;25(5):773–784. doi: 10.1016/j.jval.2022.01.001
   PubMed Web of Science ®Google Scholar
• Frediani JK, Levy JM, Rao A, et al. Multidisciplinary assessment of the abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration. Sci Rep. 2021;11(1):14604. doi: 10.1038/s41598-021-94055-1
   PubMed Web of Science ®Google Scholar
• Kruger LJ, Tanuri A, Lindner AK, et al. Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: a multi-centre clinical evaluation. EBioMedicine. 2022;75:103774. doi: 10.1016/j.ebiom.2021.103774
   PubMed Web of Science ®Google Scholar
• Panpradist N, Kline EC, Atkinson RG, et al. Harmony COVID-19: a ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection. Sci Adv. 2021;7(51):eabj1281. doi: 10.1126/sciadv.abj1281
   PubMed Web of Science ®Google Scholar
• Nkengasong J. Let Africa into the market for COVID-19 diagnostics. Nature. 2020;580(7805):565. doi:10.1038/d41586-020-01265-0
   PubMed Web of Science ®Google Scholar
• Dong E, Ratcliff J, Goyea TD, et al. The Johns Hopkins University center for systems science and engineering COVID-19 Dashboard: data collection process, challenges faced, and lessons learned. Lancet Infect Dis. 2022;22(12):e370–6. doi: 10.1016/S1473-3099(22)00434-0
   PubMed Web of Science ®Google Scholar
• Gardner L, Ratcliff J, Dong E, et al. A need for open public data standards and sharing in light of COVID-19. Lancet Infect Dis. 2021;21(4):e80. doi: 10.1016/S1473-3099(20)30635-6
   PubMed Web of Science ®Google Scholar
• Vahedi A, Moghaddasi H, Asadi F, et al. Applications, features and key indicators for the development of covid-19 dashboards: a systematic review study. Inform Med Unlocked. 2022;30:100910. doi: 10.1016/j.imu.2022.100910
   PubMedGoogle Scholar
• Pagel C, Yates CA. Role of mathematical modelling in future pandemic response policy. BMJ. 2022;378:e070615. doi:10.1136/bmj-2022-070615
   PubMedGoogle Scholar
• World Health Organization. High burden to high impact. A targeted malaria response. World Health Org. 2018
   Google Scholar
• Adebisi YA, Lucero-Prisno DE. 3rd. Fixing data gaps for population Health in Africa: an urgent need. Int J Public Health. 2022;67:1605418. doi:10.3389/ijph.2022.1605418
   PubMed Web of Science ®Google Scholar
• Owusu AB, Afagbedzi SK, Bandoh DA, et al. Integration of multiple geospatial applications and intelligence for responding to COVID-19 in Ghana. Ghana Med J. 2021;55(2 Suppl):10–20. doi: 10.4314/gmj.v55i2s.3
   PubMedGoogle Scholar
• Judson SD, Torimiro J, Pigott DM, et al. COVID-19 data reporting systems in Africa reveal insights for future pandemics. Epidemiol Infect. 2022;150:e119. doi: 10.1017/S0950268822001054
   PubMedGoogle Scholar
• Moser N, Yu LS, Rodriguez Manzano J, et al. Quantitative detection of dengue serotypes using a smartphone-connected handheld lab-on-chip platform. Front Bioeng Biotechnol. 2022;10:892853. doi: 10.3389/fbioe.2022.892853
   PubMed Web of Science ®Google Scholar
• Rodriguez-Manzano J, Malpartida-Cardenas K, Moser N, et al. Handheld point-of-care system for rapid detection of SARS-CoV-2 extracted RNA in under 20 min. ACS Cent Sci. 2021;7(2):307–317. doi: 10.1021/acscentsci.0c01288
   PubMed Web of Science ®Google Scholar
• Guo X, Khalid MA, Domingos I, et al. Smartphone-based DNA diagnostics for malaria detection using deep learning for local decision support and blockchain technology for security. Nat Electronics. 2021;4(8):615–624. doi: 10.1038/s41928-021-00612-x
   Web of Science ®Google Scholar
• Ross GMS, Zhao Y, Bosman AJ, et al. Best practices and current implementation of emerging smartphone based (bio)sensors - part 1: data handling and ethics. Trends Anal Chem. 2022;158:116863. doi:10.1016/j.trac.2022.116863
   Web of Science ®Google Scholar