IFCC Task Force on COVID-19, Milan, Italy.
Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Diagnosis (Berl). 2022 Mar 15;9(2):149-156. doi: 10.1515/dx-2022-0021.
We provide here a pooled analysis of accuracy of Fujirebio Lumipulse SARS-CoV-2 Antigen chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infections. An electronic search was conducted in Scopus and Medline with the keywords "Lumipulse" AND "antigen" AND "SARS-CoV-2" or "COVID-19", up to January 21, 2022, for identifying clinical investigations (minimum sample size ≥100) where diagnostic accuracy of Lumipulse G SARS-CoV-2 Ag was tested against reference molecular techniques. All studies which allowed to construct a 2 × 2 table were included in a pooled analysis. A final number of 21 studies, totalling 17,648 nasopharyngeal and 8538 saliva specimens, were finally included. The pooled diagnostic sensitivity and specificity in nasopharyngeal swabs were 0.80 (95%CI, 0.78-0.81) and 0.98 (95%CI, 0.97-0.98), respectively, whilst the area under the curve and agreement were 0.980 (95%CI, 0.973-0.986) and 94.9%, respectively. In the twelve studies which used the fixed 1.34 pg/mL currently recommended manufacturer's threshold, the diagnostic accuracy remained unvaried. In saliva samples, the pooled diagnostic sensitivity and specificity were 0.75 (95%CI, 0.71-0.75) and 1.00 (95%CI, 0.99-1.00), respectively, whilst the area under the curve and were 0.976 (95%CI, 0.969-0.984) and 98.4%, respectively. In the five studies which used the fixed 0.67 pg/mL currently recommended manufacturer's threshold, the diagnostic accuracy remained unvaried. In conclusion, Lumipulse G SARS-CoV-2 Ag assay demonstrates good diagnostic sensitivity and specificity, thus representing a valuable complementary and integrative option to molecular testing for SARS-CoV-2 in the current pandemic.
我们在此提供一项针对富士瑞必欧 Lumipulse SARS-CoV-2 抗原化学发光免疫分析检测用于诊断急性 SARS-CoV-2 感染的准确性的汇总分析。我们在 Scopus 和 Medline 上使用关键词“Lumipulse”和“抗原”和“SARS-CoV-2”或“COVID-19”进行了电子检索，检索截至 2022 年 1 月 21 日，以确定临床研究（最小样本量≥100），其中对 Lumipulse G SARS-CoV-2 Ag 的诊断准确性进行了测试，并与参考分子技术进行了比较。所有允许构建 2×2 表格的研究均被纳入汇总分析。最终纳入了 21 项研究，共涉及 17648 例鼻咽拭子和 8538 例唾液样本。在鼻咽拭子中，汇总分析的诊断敏感性和特异性分别为 0.80（95%CI，0.78-0.81）和 0.98（95%CI，0.97-0.98），曲线下面积和一致性分别为 0.980（95%CI，0.973-0.986）和 94.9%。在使用目前推荐的制造商固定阈值 1.34pg/mL 的 12 项研究中，诊断准确性保持不变。在唾液样本中，汇总分析的诊断敏感性和特异性分别为 0.75（95%CI，0.71-0.75）和 1.00（95%CI，0.99-1.00），曲线下面积分别为 0.976（95%CI，0.969-0.984）和 98.4%。在使用目前推荐的制造商固定阈值 0.67pg/mL 的 5 项研究中，诊断准确性保持不变。总之，Lumipulse G SARS-CoV-2 Ag 检测试剂盒具有良好的诊断敏感性和特异性，因此是目前 SARS-CoV-2 大流行期间分子检测的一种有价值的补充和整合选择。
