Fujirebio Lumipulse SARS-CoV-2 antigen immunoassay: pooled analysis of diagnostic accuracy

Abstract: 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.

Show object

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch

References and Relationships

• Bibliographic citation: Fujirebio Lumipulse SARS-CoV-2 antigen immunoassay: pooled analysis of diagnostic accuracy ; volume:9 ; number:2 ; year:2022 ; pages:149-156 ; extent:08 ; Diagnosis ; 9, Heft 2 (2022), 149-156 (gesamt 08)

Contributors, Places and Time

• Creator: Lippi, Giuseppe ; Henry, Brandon M. ; Adeli, Khosrow ; Plebani, Mario

Further information

• DOI: 10.1515/dx-2022-0021
• URN: urn:nbn:de:101:1-2412011727442.912616568201
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.