Lippi Giuseppe, Henry Brandon M, Plebani Mario
Section of Clinical Biochemistry and School of Medicine, University of Verona, 37134 Verona, Italy.
Cardiac Intensive Care Unit, The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
Diagnostics (Basel). 2022 Apr 11;12(4):947. doi: 10.3390/diagnostics12040947.
We present here a critical literature review and meta-analysis on the accuracy of the LumiraDX SARS-CoV-2 Antigen Test for diagnosing acute SARS-CoV-2 infection. An electronic search was conducted in the Scopus and Medline databases using the keywords "LumiraDX" AND "COVID-19" OR "SARS-CoV-2", without date (i.e., up to 1 February 2022) or language restrictions, for detecting clinical studies where the diagnostic accuracy of the LumiraDX SARS-CoV-2 Antigen Test was compared with reference molecular diagnostic methods. All studies where the rates of true positive, true negative, false positive and false negative cases were available for constructing a 2 × 2 table and providing pooled estimates of diagnostic sensitivity, specificity and accuracy were included in a pooled analysis. The study was conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) reporting checklist. Eleven studies ( = 8527 samples) could be included in our pooled analysis, while five additional documents provided diagnostic accuracy data but could not be extracted for construction of a 2 × 2 table. The pooled diagnostic sensitivity and specificity were 0.86 (95%CI, 0.84-0.88) and 0.99 (95%CI, 0.98-0.99), respectively, while the area under the summary receiver operating characteristic curve was 0.974 (95%CI, 0.965-0.983) and the agreement was 96.8% (95%CI, 96.4-97.1%), with kappa statistics of 0.87 (95%CI, 0.85-0.88). In conclusion, the diagnostic performance of the LumiraDX SARS-CoV-2 Antigen Test would allow the conclusion that it may be seen as a reliable alternative to molecular testing for the rapid preliminary screening of acute SARS-CoV-2 infections.
我们在此呈现一篇关于LumiraDX SARS-CoV-2抗原检测诊断急性SARS-CoV-2感染准确性的批判性文献综述和荟萃分析。使用关键词“LumiraDX”以及“COVID-19”或“SARS-CoV-2”在Scopus和Medline数据库中进行电子检索，无日期（即截至2022年2月1日）或语言限制，以查找将LumiraDX SARS-CoV-2抗原检测的诊断准确性与参考分子诊断方法进行比较的临床研究。所有可获得真阳性、真阴性、假阳性和假阴性病例率以构建2×2表格并提供诊断敏感性、特异性和准确性汇总估计值的研究都纳入了汇总分析。该研究按照PRISMA（系统评价和荟萃分析的首选报告项目）报告清单进行。我们的汇总分析纳入了11项研究（n = 8527个样本），另有5份文件提供了诊断准确性数据，但无法提取用于构建2×2表格。汇总诊断敏感性和特异性分别为0.86（95%CI，0.84 - 0.88）和0.99（95%CI，0.98 - 0.99），而汇总受试者操作特征曲线下面积为0.974（95%CI，0.965 - 0.983），一致性为96.8%（95%CI，96.4 - 97.1%），kappa统计量为0.87（95%CI，0.85 - 0.88）。总之，LumiraDX SARS-CoV-2抗原检测的诊断性能表明，它可被视为用于急性SARS-CoV-2感染快速初步筛查的分子检测的可靠替代方法。
