J Am Pharm Assoc (2003). 2024 Jul-Aug;64(4):102090. doi: 10.1016/j.japh.2024.102090. Epub 2024 Apr 9.
Many multiplex CLIA-waived point of care tests are available in the United States for community pharmacists to incorporate into their practice.
To characterize the eleven multiplex CLIA-waived point of care tests available for detecting SARS-CoV-2 and influenza A and B ± other respiratory pathogens and summarize their performance characteristics from published studies.
Food and Drug Administration websites and databases were utilized to identify currently available tests. Literature searches were conducted and most recently updated through July 21, 2023 to identify studies examining the tests' performance. Primary literature was included if it reported positive and negative percent agreement (PPA and NPA, respectively) for SARS-CoV-2 or influenza A or B, had a comparator, and was conducted in a CLIA-waived environment. Relevant study characteristics, including number of samples, sample collection method, age of participants, comparator, PPA/NPA for SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) were extracted. Data extraction was performed by two authors with any discordant data reconciled by a third author.
Twenty-eight studies met inclusion criteria. The PPA for SARS-CoV-2 ranged from 86.7% to 100%, and NPA ranged from 90.4% to 100%. The PPA for influenza A and B ranged from 92.9% to 100% and 95.3% to 100%, respectively, while NPA ranged from 96.6% to 100% and 98.2% to 100%, respectively. Both the Xpert Xpress Plus and SpotFire tests showed similar results for RSV with PPA ranging from 96.3% to 100% and NPA ranging from 98.4% to 100%.
Currently available multiplex POCT for SARS CoV-2 and influenza A and B ± RSV have demonstrated efficacy in detecting multiple pathogens in a single test. Pathogen detection, costs, materials needed to perform the test (eg, readers), and study data (PPA and NPA) should be utilized to help determine which tests should be ordered for a particular practice setting.
美国有许多多重 CLIA 豁免的即时检测点护理测试可供社区药剂师纳入其实践。
描述目前可用于检测 SARS-CoV-2 和流感 A 和 B 以及其他呼吸道病原体的十一种多重 CLIA 豁免的即时检测点护理测试，并从已发表的研究中总结其性能特征。
利用食品和药物管理局的网站和数据库来识别当前可用的测试。进行文献检索，并于 2023 年 7 月 21 日更新，以确定研究这些测试性能的研究。如果报告了 SARS-CoV-2 或流感 A 或 B 的阳性和阴性百分比一致（分别为 PPA 和 NPA）、有比较者、并在 CLIA 豁免环境中进行的研究，则纳入主要文献。提取了相关研究特征，包括样本数量、样本采集方法、参与者年龄、比较者、SARS-CoV-2、流感 A 和 B 以及呼吸道合胞病毒（RSV）的 PPA/NPA。由两名作者进行数据提取，如果数据存在分歧，则由第三名作者进行协调。
28 项研究符合纳入标准。SARS-CoV-2 的 PPA 范围为 86.7%至 100%，NPA 范围为 90.4%至 100%。流感 A 和 B 的 PPA 范围分别为 92.9%至 100%和 95.3%至 100%，NPA 范围分别为 96.6%至 100%和 98.2%至 100%。Xpert Xpress Plus 和 SpotFire 测试对 RSV 的检测结果相似，PPA 范围为 96.3%至 100%，NPA 范围为 98.4%至 100%。
目前可用的 SARS-CoV-2 和流感 A 和 B 以及 RSV 的多重 POCT 已证明在单个测试中检测多种病原体的功效。应利用病原体检测、成本、进行测试所需的材料（例如，读取器）和研究数据（PPA 和 NPA）来帮助确定在特定实践环境中应订购哪些测试。
