Clinical comparison and agreement of PCR, antigen, and viral culture for the diagnosis of COVID-19

Agard, Amanda; Elsheikh, Omar; Bell, Drew T.; Relich, Ryan F.; Schmitt, Bryan H.; Sadowski, Josh; Fadel, William F.; Webb, Douglas; Dbeibo, Lana; Kelley, Kristen; Carozza, Mariel; Lei, Guang-Shen; Calkins, Paul; Beeler, Cole

doi:10.1016/j.jcvp.2022.100099

Cited by 3 publications

(4 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Finally, in the four studies which included mixed cohorts of asymptomatic and symptomatic patients (all except one using nasopharyngeal samples; and study excluded due to lack of negative controls) (Figure 4), the AUC was 0.960 (with 0.03 SE), the sensitivity 0.77 (95%CI, 0.75-0.80; I 2 , 99%) and the specificity 0.99 (95%CI, 0.99-1.00; I 2 , 93%). Table 3 synthesizes the diagnostic performance of four other studies [34][35][36][37] which reported quantitative data on the diagnostic accuracy of Quidel Sofia SARS antigen FIA, but were excluded due to unavailability of sufficient information for constructing a 22 table.…”

Section: Resultsmentioning

confidence: 99%

“…However, in such settings, it could be theoretically used to identify those with higher viral load, who may be responsible for a substantially higher burden of transmission. [34] Low-risk 0.26 (-) 1.00 (-) Agard et al, 2022 [34] High-risk 0.37 (-) 1.00 (-) Al-Alawi et al, 2021 [35] Symptomatic patients 0.64 (0.50-0.77) 0.97 (0.95-0.98) Brihn et al, 2021 [36] Asymptomatic patients 0.60 (0.50-0.71) 1.00 (0.99-1.00) Brihn et al, 2021 [36] Symptomatic patients 0.72 (0.61-0.83) 0.99 (0.97-1.00) Schroeder et al, 2022 [37]…”

Section: Discussionmentioning

confidence: 99%

“…According to manufacturer's indications, the assay should be specifically used for SARS-CoV-2 testing using direct nasal swabs collected from symptomatic patients within the first 5 days of symptoms onset, or for serial testing of asymptomatic patients (in such case within [24][25][26][27][28][29][30][31][32][33][34][35][36] hours between repeated tests). The test has been cleared for being used at as a POC, under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.…”

Section: Assay Descriptionmentioning

confidence: 99%

See 2 more Smart Citations

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

Lippi¹,

Henry²,

Plebani³

2023

Preprint

View full text Add to dashboard Cite

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.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Assay Descriptionmentioning

confidence: 99%

See 1 more Smart Citation

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

Lippi¹,

Henry²,

Plebani³

2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Specimens were cultured on Vero E6 monolayers in 6-well tissue culture plates, as previously described [15] . Cell cultures were tested on days 0 and 8 of incubation using a laboratory-developed nucleic acid amplification test to determine the presence of replicating SARS-CoV-2: a decrease of at least 4 C T values during culture incubation indicated viral replication.…”

Section: Methodsmentioning

confidence: 99%

Comparison of nucleocapsid antigen with strand-specific reverse-transcription PCR for monitoring SARS-CoV-2 infection

Chang‐Graham¹,

Sahoo²,

Huang³

et al. 2023

Journal of Clinical Virology

View full text Add to dashboard Cite

Determination of the cycle threshold value of the Xpert Xpress SARS-CoV-2/Flu/RSV test that corresponds to the presence of infectious SARS-CoV-2 in anterior nasal swabs

Relich,

Van Benten,

Lei

et al. 2024

Microbiol Spectr

View full text Add to dashboard Cite

Despite having high analytical sensitivities and specificities, qualitative SARS-CoV-2 nucleic acid amplification tests (NAATs) cannot distinguish infectious from non-infectious virus in clinical samples. In this study, we determined the highest cycle threshold (Ct) value of the SARS-CoV-2 targets in the Xpert Xpress SARS-CoV-2/Flu/RSV (Xpert 4plex) test that corresponded to the presence of detectable infectious SARS-CoV-2 in anterior nasal swab samples. A total of 111 individuals with nasopharyngeal swab specimens that were initially tested by the Xpert Xpress SARS-CoV-2 test were enrolled. A healthcare worker subsequently collected anterior nasal swabs from all SARS-CoV-2-positive individuals, and those specimens were tested by the Xpert 4plex test, viral culture, and laboratory-developed assays for SARS-CoV-2 replication intermediates. SARS-CoV-2 Ct values from the Xpert 4plex test were correlated with data from culture and replication intermediate testing to determine the Xpert 4plex assay Ct value that corresponded to the presence of infectious virus. Ninety-eight of the 111 (88.3%) individuals initially tested positive by the Xpert Xpress SARS-CoV-2 test. An anterior nasal swab specimen collected from positive individuals a median of 2 days later (range, 0–9 days) tested positive for SARS-CoV-2 by the Xpert 4plex test in 39.8% (39/98) of cases. Of these samples, 13 (33.3%) were considered to contain infectious virus based on the presence of cultivable virus and replication intermediates, and the highest Ct value observed for the Xpert 4plex test in these instances was 26.3. Specimens that yielded Ct values of ≤26.3 when tested by the Xpert 4plex test had a likelihood of containing infectious SARS-CoV-2; however, no infectious virus was detected in specimens with higher Ct values. IMPORTANCE Understanding the correlation between real-time PCR test results and the presence of infectious SARS-CoV-2 may be useful for informing patient management and workforce return-to-work or -duty. Further studies in different patient populations are needed to correlate Ct values or other biomarkers of viral replication along with the presence of infectious virus in clinical samples.

show abstract

Clinical comparison and agreement of PCR, antigen, and viral culture for the diagnosis of COVID-19

Cited by 3 publications

References 29 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)

Comparison of nucleocapsid antigen with strand-specific reverse-transcription PCR for monitoring SARS-CoV-2 infection

Determination of the cycle threshold value of the Xpert Xpress SARS-CoV-2/Flu/RSV test that corresponds to the presence of infectious SARS-CoV-2 in anterior nasal swabs

Contact Info

Product

Resources

About