Another false-positive problem for a SARS-CoV-2 antigen test in Japan

Ogawa, Taku; Fukumori, Tatsuya; Nishihara, Yuji; Sekine, Takahiro; Okuda, Nao; Nishimura, Tomoko; Fujikura, Hiroyuki; Hirai, Nobuyasu; Imakita, Natsuko; Kasahara, Kei

doi:10.1016/j.jcv.2020.104612

Cited by 52 publications

(46 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Out of 58 RT-PCR positive patients, 26 (44.8%) were negative on the LUMIPULSE. The specificity of the test ranged from 97.3% to 99.6% [ 29 , 30 ]. They also observed a weaker correlation with viral load (i.e., R 2 = 0.77) compared to our evaluation with the VITROS automated assay (i.e., R 2 = 0.94), which in our hands, showed excellent clinical performance.…”

Section: Discussionmentioning

confidence: 99%

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

View full text Add to dashboard Cite

(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.

show abstract

Section: Discussionmentioning

confidence: 99%

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

View full text Add to dashboard Cite

show abstract

“…Although it is necessary to verify whether similar results can be obtained in other settings, false positives should be avoided to prevent unnecessary additional testing and inappropriate isolation measures (14).…”

Section: Comparison Of Degrees Of Coughs or Sneezes Induction And Thementioning

confidence: 96%

Diagnostic Performance and Characteristics of Anterior Nasal Collection for the SARS-CoV-2 Antigen Test: A Prospective Study in Japan

Takeuchi

Akashi

Kato

et al. 2021

Preprint

View full text Add to dashboard Cite

We conducted a prospective study in Japan to evaluate the diagnostic performance of the antigen test QuickNavi-COVID19 Ag using anterior nasal samples and to compare the degrees of coughs or sneezes induction and the severity of pain between anterior nasal collection and nasopharyngeal collection. A total of 862 participants were included in the analysis. In comparison to the findings of reverse transcription PCR using nasopharyngeal samples, the antigen test using anterior nasal samples showed 72.5% sensitivity (95% confidence interval [CI]: 58.3%-84.1%) and 100% specificity (95% CI: 99.3%-100%). Anterior nasal collection was associated with a significantly lower degree of coughs or sneezes induction and the severity of pain in comparison to nasopharyngeal collection (p < 0.001). The antigen test using anterior nasal samples showed moderate sensitivity but was less painful and induced fewer coughs or sneezes.

show abstract

“…However, RT-qPCR remains expensive and often has sample-to-result times of 24-48 h as a laboratory-based assay. New developments in SARS-CoV-2 diagnostics have the potential to reduce cost significantly, thus allowing for expanded testing or greater frequency of testing and reducing turnaround time to minutes [5][6][7][8][9][10][11][12][13] . Several diagnostic strategies are available for identifying or ruling out current infection, identifying people in need of care escalation, or testing for past infection and immune response.…”

Section: Introductionmentioning

confidence: 99%

An optimized stepwise algorithm combining rapid antigen and RT-qPCR for screening of COVID-19 patients

Halfon

Pénaranda

Khiri

et al. 2021

Preprint

View full text Add to dashboard Cite

BackgroundDiagnosing SARS CoV-2 infection with certainty is essential for appropriate case management. We investigated the combination of rapid antigen detection (RAD) and RT-qPCR assays in a stepwise procedure to optimize the detection of COVID-19.MethodsFrom August 2020 to November 2020, 43,399 patients were screened in our laboratory for COVID-19 diagnostic by RT-qPCR using nasopharyngeal swab. Overall, 4,691 of the 43,399 were found to be positive, and 200 were retrieved for RAD testing allowing comparison of diagnostic accuracy between RAD and RT-qPCR. Cycle threshold (Ct) and time from symptoms onset (TSO) were included as covariates.ResultsThe overall sensitivity, specificity, PPV, NPV, LR-, and LR+ of RAD compared with RT- qPCR were 72% (95%CI 62%–81%), 99% (95% CI95%–100%), 99% (95%CI 93%–100%), and 78% (95%CI 70%–85%), 0.28 (95%CI 0.21-0.39), and 72 (95%CI 10-208) respectively. Sensitivity was higher for patients with Ct ≤ 25 regardless of TSO: TSO ≤ 4 days 92% (95%CI 75%–99%), TSO > 4 days 100% (95%CI 54%–100%), and asymptomatic 100% (95%CI 78-100%). Overall, combining RAD and RT-qPCR would allow reducing from only 4% the number of RT-qPCR needed.ConclusionThis study highlights the risk of misdiagnosing COVID-19 in 28% of patients if RAD is used alone. Thus, negative results from RAD needs to be confirmed by RT-qPCR prior to making treatment decisions. A stepwise analysis that combines RAD and RT-qPCR would be an efficient screening procedure for COVID-19 detection and may facilitate the control of the outbreak.

show abstract

Another false-positive problem for a SARS-CoV-2 antigen test in Japan

Cited by 52 publications

References 2 publications

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Diagnostic Performance and Characteristics of Anterior Nasal Collection for the SARS-CoV-2 Antigen Test: A Prospective Study in Japan

An optimized stepwise algorithm combining rapid antigen and RT-qPCR for screening of COVID-19 patients

Contact Info

Product

Resources

About