Your browser doesn't support javascript.
Fujirebio Lumipulse SARS-CoV-2 antigen immunoassay: pooled analysis of diagnostic accuracy.
Lippi, Giuseppe; Henry, Brandon M; Adeli, Khosrow; Plebani, Mario.
  • Lippi G; IFCC Task Force on COVID-19, Milan, Italy.
  • Henry BM; Section of Clinical Biochemistry, University of Verona, Verona, Italy.
  • Adeli K; IFCC Task Force on COVID-19, Milan, Italy.
  • Plebani M; Clinical Laboratory, Division of Nephorlogy and Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Diagnosis (Berl) ; 9(2): 149-156, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1742046
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study / Reviews Limits: Humans Language: English Journal: Diagnosis (Berl) Year: 2022 Document Type: Article Affiliation country: Dx-2022-0021

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study / Reviews Limits: Humans Language: English Journal: Diagnosis (Berl) Year: 2022 Document Type: Article Affiliation country: Dx-2022-0021