review · Frontiers in Medicine
Rapid diagnostic tests for COVID-19 antigens and antibodies offer potential to complement central molecular testing in low-resource environments. A review of 47 articles covering 56 test formats alongside manufacturer instructions examined the requirements for deploying these diagnostics in sub-Saharan Africa. None of the identified studies were conducted within the region, and few assessed capillary blood sampling at the point of care. Implementation faces hurdles, including the need to validate whole blood sampling, unconfirmed test specificity against tropical pathogens, and sensitivity limitations. Furthermore, many commercial test kits lack critical components such as flocked swabs, lancets, and controls, while exhibiting usability defects like faint lines and poorly designed buffer vials. Realising effective deployment across triage, contact tracing, and surveillance requires updated target product profiles, certified manufacturing, and coordination with national laboratory networks.
Rapid diagnostic tests offer a decentralised way to expand disease screening in low-resource settings where central molecular laboratories are limited. Identifying the technical and logistical shortcomings of existing test kits ensures that health systems can procure and deploy reliable tools for patient triage, contact tracing, and disease surveillance without compromising diagnostic accuracy or safety.
Diagnostic manufacturers and health procurement agencies can use these findings to design and supply complete, field-ready test kits tailored to low-resource settings. The evidence highlights an applied gap: while rapid tests are near-market or commercialised, kits require improved configurations, including bundled finger-prick tools and better buffer vials, alongside validation against regional pathogens and integration with national laboratory networks to achieve reliable field adoption.
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<b>Introduction:</b> For the COVID-19 (SARS-CoV-2) response, COVID-19 antigen (Ag), and antibody (Ab) rapid diagnostic tests (RDTs) are expected to complement central molecular testing particularly in low-resource settings. The present review assesses requirements for implementation of COVID-19 RDTs in sub-Saharan Africa. <b>Methods:</b> Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products. <b>Results:</b> In total 47 articles on two COVID-19 Ag RDTs and 54 COVID-19 Ab RDTs and IFUs of 20 COVID-19 Ab RDTs were retrieved. Only five COVID-19 Ab RDTs (9.3%) were assessed with capillary blood sampling at the point-of-care; none of the studies were conducted in sub-Saharan Africa. <i>Sampling:</i> Challenges for COVID-19 Ag RDTs include nasopharyngeal sampling (technique, biosafety) and sample stability; for COVID-19 Ab RDTs equivalence of whole blood vs. plasma/serum needs further validation (assessed for only eight (14.8%) products). <i>Sensitivity-Specificity</i>: sensitivity of COVID-19 Ag and Ab RDTs depend on viral load (antigen) and timeframe (antibody), respectively; COVID-19 Ab tests have lower sensitivity compared to laboratory test platforms and the kinetics of IgM and IgG are very similar. Reported specificity was high but has not yet been assessed against tropical pathogens. <i>Kit configuration:</i> For COVID-19 Ag RDTs, flocked swabs should be added to the kit; for COVID-19 Ab RDTs, finger prick sampling materials, transfer devices, and controls should be added (currently only supplied in 15, 5, and 1/20 products). <i>Usability and Robustness: s</i>ome COVID-19 Ab RDTs showed high proportions of faint lines (>40%) or invalid results (>20%). Shortcomings were reported for buffer vials (spills, air bubbles) and their instructions for use. <i>Stability:</i> storage temperature was ≤ 30°C for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. <i>Integration in the healthcare setting</i> requires a target product profile, landscape overview of technologies, certified manufacturing capacity, a sustainable market, and a stringent but timely regulation. In-country deployment depends on integration in the national laboratory network. <b>Discussion/Conclusion:</b> Despite these limitations, successful implementation models in triage, contact tracing, and surveillance have been proposed, in particular for COVID-19 Ab RDTs. Valuable experience is available from implementation of other disease-specific RDTs in sub-Saharan Africa.
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DOI: 10.3389/fmed.2020.557797
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