Pooled analysis of laboratory-based SARS-CoV-2 antigen immunoassays

Lippi, Giuseppe; Henry, Brandon Michael; Plebani, Mario

doi:10.1515/cclm-2022-1321

Cited by 4 publications

(3 citation statements)

References 10 publications

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“…In conclusion, the results of this critical literature review and meta-analysis suggest that the modest but significant improvement shown by the instrument-read Quidel Sofia SARS Ag FIA over more traditional “optically only”-read RDT-Ag would straightforwardly align its diagnostic accuracy to that exhibited cumulatively by laboratory-based SARS-CoV-2 immunoassays, (i.e., 0.76 vs. 0.73 sensitivity and 1.00 vs. 0.98 specificity) [ 10 ]. This test may hence combine satisfactory diagnostic performance with the advantages of being potentially used as a POC.…”

Section: Discussionmentioning

confidence: 99%

“…Recent literature review revealed that although most laboratory-based tests seem to fulfil these performance limits [10], the diagnostic accuracy of RDT-Ag varies broadly, with average sensitivity of 0.73 (95%CI, 0.69-0.76) in symptomatic subjects, decreasing to 0.55 (95%CI, 0.48-0.62) in those without symptoms [11]. Importantly, according to the Cochrane COVID-19 Diagnostic Test Accuracy Group, the vast majority of tests failed to meet the WHO and IFCC minimum sensitivity criterion of ≥0.80, thus raising serious doubts about their reliability and safety [11].…”

Section: Introductionmentioning

confidence: 99%

“…As concerns the specific diagnostic performance of SARS-CoV-2 Ag testing, both the WHO [ 8 ] and the IFCC [ 5 , 9 ] mandate that minimum performance criteria shall be met by SARS-CoV-2 Ag immunoassays, either rapid diagnostic tests (RDT-Ag) or laboratory based, in that they should display ≥0.80 sensitivity and ≥0.97 specificity, respectively, when used in suspected COVID-19 cases (i.e., symptomatic subjects). Recent literature review revealed that although most laboratory-based tests seem to fulfil these performance limits [ 10 ], the diagnostic accuracy of RDT-Ag varies broadly, with average sensitivity of 0.73 (95%CI, 0.69-0.76) in symptomatic subjects, decreasing to 0.55 (95%CI, 0.48-0.62) in those without symptoms [ 11 ]. Importantly, according to the Cochrane COVID-19 Diagnostic Test Accuracy Group, the vast majority of tests failed to meet the WHO and IFCC minimum sensitivity criterion of ≥0.80, thus raising serious doubts about their reliability and safety [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

Lippi¹,

Henry²,

Plebani³

2023

Preprint

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Background. This article presents a critical literature review and meta-analysis of diagnostic performance of Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), a rapid diagnostic antigen test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages of point-of-care testing with those of a laboratory-based immunoassay. Methods: We conduced an electronic search in PubMed and Scopus with the keywords "Quidel" OR “SOFIA” AND “Antigen” AND "SARS-CoV-2" OR “COVID-19” up to March 24, 2023, for identifying articles containing data on accuracy of Quidel Sofia SARS antigen FIA for diagnosing acute SARS-CoV-2 infections. We selected those where test accuracy was compared to that of a reference SARS-CoV-2 molecular assay, and with sufficient information for constructing a 2×2 table. Results: A total number of 18 articles (48165 samples; 9.8% positive at molecular testing) were included in this meta-analysis, averaging 24 sample cohorts. The diagnostic accuracy (summary area under the curve), sensitivity and specificity were 0.980, 0.76 and 1.00 in all samples, 0.981, 0.81 and 0.99 in samples collected from symptomatic patients, 0.931, 0.55 and 1.00 in those taken from asymptomatic patients, and 0.960, 0.77 and 0.99 in samples from mixed cohorts of patients, respectively. Minor and clinically negligible differences of accuracy could be found by comparing test results in nasal and nasopharyngeal swabs. Conclusion: Quidel Sofia SARS Ag FIA meets the minimum performance criteria of accuracy for SARS-CoV-2 antigenic testing, thus combining satisfactory diagnostic performance with the advantages of being potentially used as a portable device.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

Lippi¹,

Henry²,

Plebani³

2023

Preprint

Self Cite

View full text Add to dashboard Cite

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Cost-effectiveness analysis of different COVID-19 screening strategies based on rapid or laboratory-based SARS-CoV-2 antigen testing

Pighi

Henry

Mattiuzzi³

et al. 2023

Clinical Chemistry and Laboratory Medicine (CCLM)

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Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay

Pighi

Henry

Nitto

et al. 2023

Clinical Chemistry and Laboratory Medicine (CCLM)

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Objectives Given that SARS-CoV-2 antigen tests will represent a pillar for supporting or surrogating molecular testing in the endemic period, we report here the clinical performance of the new SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay (MAG-CLIA SARS-CoV-2 Ag). Methods The study population consisted of 181 subjects (mean age 61 ± 21 years; 92 females) undergoing coronavirus disease 2019 (COVID-19) testing at the local diagnostic facility, from December 2022 to February 2023. Routine diagnostic practice involved the collection of a double nostril nasopharyngeal swab, analyzed in duplicate with SARS-CoV-2 antigen (MAG-CLIA SARS-CoV-2 Ag) and molecular (Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit) tests. Results A significant Spearman’s correlation was found between MAG-CLIA SARS-CoV-2 Ag and mean Ct values of SARS-CoV-2 E and S genes (r=−0.95; p<0.001). In all nasopharyngeal samples, the area under the curve (AUC) of MAG-CLIA SARS-CoV-2 Ag was 0.86 (95% CI, 0.81–0.90), with 0.71 sensitivity and 1.00 specificity at 7 ng/L cut-off, increasing to 0.98 (95% CI, 0.96–1.00) AUC and 0.96 sensitivity (with 0.97 specificity) in high viral load samples. When SARS-CoV-2 N protein concentration was replaced with raw instrumental readings (i.e., relative light units [RLU]), the AUC in all samples increased to 0.94. A RLU value of 945 was associated with 88.4% accuracy, 0.85 sensitivity, 0.95 specificity, 0.77 negative predictive value (NPV) and 0.97 positive predictive value (PPV), respectively. Conclusions We found satisfactory analytical performance of MAG-CLIA SARS-CoV-2 Ag, which could be used as surrogate of molecular testing for identifying high viral load samples. Broadening the reportable range of values may generate even better performance.

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Pooled analysis of laboratory-based SARS-CoV-2 antigen immunoassays

Cited by 4 publications

References 10 publications

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

Cost-effectiveness analysis of different COVID-19 screening strategies based on rapid or laboratory-based SARS-CoV-2 antigen testing

Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay

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