School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, 3083, Australia.
Northern Pathology Victoria, Northern Health, Epping, VIC, 3076, Australia.
Mol Diagn Ther. 2023 May;27(3):303-320. doi: 10.1007/s40291-022-00637-8. Epub 2023 Jan 27.
The accuracy of diagnostic laboratory tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can impact downstream clinical procedures in managing and controlling the outbreak of coronavirus disease 2019 (COVID-19). To assess the effectiveness of laboratory tools for managing COVID-19 patients in low-income countries (LICs), we systematically searched the PubMed, Embase, Scopus and CINHAL databases for reports published between January 2020 and June 2022. We found that 22 of 1303 articles reported the performance of various SARS-CoV-2 detection tools across 10 LICs. These tools were (1) real-time reverse transcriptase polymerase chain reaction (RT-PCR); (2) reverse transcription loop-mediated isothermal amplification (RT-LAMP); (3) rapid diagnostic tests (RDTs); (4) enzyme-linked immunosorbent assay (ELISA); and (5) dot-blot immunoassay. The detection of COVID-19 is largely divided into two main streams-direct virus (antigen) detection and serology (immunoglobulin)-based detection. Point-of-care testing using antigen-based RDTs is preferred in LICs because of cost effectiveness and simplicity in the test procedures. The nucleic acid amplification technology (RT-PCR and RT-LAMP) has the highest diagnostic performance among the available tests, but it is not broadly used in this context due to costs and shortage of facilities/trained staff. The serology-based test method is affected by antibody interferences and varying amounts of SARS-CoV-2 immunoglobulins expressed at different stages of disease onset. We further discuss the effectiveness and shortcomings of each of these tools in the diagnosis and management of COVID-19. Using the LICs as the study model, our findings highlight ways to improve the quality and turnaround time of COVID-19 testing in resource-constrained settings, notably through local/international collaborative efforts to refine the molecular-based or immunoassay-based testing technologies.
诊断实验室检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的准确性会影响 2019 冠状病毒病 (COVID-19) 大流行期间管理和控制的下游临床程序。为了评估实验室工具在管理低收入国家 (LIC) 的 COVID-19 患者方面的有效性,我们系统地检索了 PubMed、Embase、Scopus 和 CINHAL 数据库,以获取 2020 年 1 月至 2022 年 6 月期间发表的报告。我们发现,在 1303 篇文章中有 22 篇报告了在 10 个 LIC 中使用各种 SARS-CoV-2 检测工具的性能。这些工具是(1)实时逆转录聚合酶链反应 (RT-PCR);(2)逆转录环介导等温扩增 (RT-LAMP);(3)快速诊断测试 (RDT);(4)酶联免疫吸附测定 (ELISA);和(5)斑点印迹免疫测定。COVID-19 的检测主要分为两大主流——直接病毒(抗原)检测和基于免疫球蛋白的检测。基于抗原的 RDT 的即时护理测试由于成本效益和测试程序简单,在 LIC 中更受欢迎。在可用的测试中,核酸扩增技术 (RT-PCR 和 RT-LAMP) 具有最高的诊断性能,但由于成本和设施/训练有素的人员短缺,在这种情况下并未广泛使用。基于血清学的测试方法受到抗体干扰和 SARS-CoV-2 免疫球蛋白在疾病发作不同阶段表达量的影响。我们进一步讨论了这些工具在 COVID-19 诊断和管理中的有效性和缺点。以 LIC 作为研究模型,我们的研究结果强调了如何通过本地/国际合作努力来改进资源有限环境中 COVID-19 检测的质量和周转时间,特别是通过改进分子或免疫测定技术。
Med Hypotheses. 2020-4-25
Biosensors (Basel). 2023-8-31
Diagnostics (Basel). 2023-3-15
Vaccines (Basel). 2022-1-30