Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review.
Implementing COVID-19 (SARS-CoV-2) Rapid Diagnostic Tests in Sub-Saharan Africa: A Review.
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DOI：
10.3389/fmed.2020.557797
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发表时间：
2020
影响因子：
3.9
通讯作者：
Vandenberg O
中科院分区：
文献类型：
--
作者：
Jacobs J;Kühne V;Lunguya O;Affolabi D;Hardy L;Vandenberg O
简介：对于COVID-19（SARS-CoV-2）应对，COVID-19抗原（Ag）和抗体（Ab）快速诊断检测（RDT）预计将补充中央分子检测，特别是在低资源环境中。本次审查评估了在撒哈拉以南非洲实施COVID-19 RDT的要求。方法：回顾PubMed发表的评估COVID-19 RDT的文章，并补充产品的使用说明书（IFU）。结果：共检索到47篇关于2种COVID-19 Ag RDT和54种COVID-19 Ab RDT的文章以及20种COVID-19 Ab RDT的IFU。只有5例COVID-19 Ab RDT（9.3%）在护理点通过毛细血管采血进行了评估;这些研究均未在撒哈拉以南非洲进行。抽样：COVID-19 Ag RDT的挑战包括鼻咽采样（技术、生物安全性）和样本稳定性;对于COVID-19 Ab RDT，全血与血浆/血清的等效性需要进一步验证（仅对8种（14.8%）产品进行了评估）。灵敏度-特异性：COVID-19 Ag和Ab RDT的灵敏度分别取决于病毒载量（抗原）和时间框架（抗体）;与实验室检测平台相比，COVID-19 Ab检测的灵敏度较低，IgM和IgG的动力学非常相似。报告的特异性很高，但尚未对热带病原体进行评估。套件配置：对于COVID-19 Ag RDT，应在试剂盒中添加植绒拭子;对于COVID-19 Ab RDT，应添加手指针刺采样材料、转移装置和质控品（目前仅在15、5和1/20产品中提供）。可用性和稳健性：一些COVID-19 Ab RDT显示高比例的模糊线（>40%）或无效结果（>20%）。报告了缓冲液瓶（溢出物、气泡）及其使用说明书的缺陷。稳定性：除一种RDT外，所有RDT的储存温度均≤ 30°C，使用中和结果稳定性分别在1 h和30 min时最大。在医疗保健环境中的整合需要目标产品概况、技术概况、认证的制造能力、可持续的市场以及严格但及时的监管。国内部署取决于与国家实验室网络的整合。讨论/结论：尽管存在这些限制，但已提出了在分诊、接触者追踪和监测方面的成功实施模式，特别是针对COVID-19 Ab RDT。在撒哈拉以南非洲执行其他疾病诊断治疗小组的过程中获得了宝贵的经验。
Introduction: 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. Methods: Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products. Results: 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. Sampling: 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). Sensitivity—Specificity: 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. Kit configuration: 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). Usability and Robustness: some 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. Stability: storage temperature was ≤ 30°C for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. Integration in the healthcare setting 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. Discussion/Conclusion: 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.