A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag

Takeuchi, Yuto; Akashi, Yusaku; Kiyasu, Yoshihiko; Terada, Norihiko; Kurihara, Yoko; Kato, Daisuke; Miyazawa, T.; Muramatsu, Shino; Shinohara, Yuki; Ueda, Atsuo; Notake, Shigeyuki; Nakamura, Koji; Suzuki, Hiromichi

doi:10.1016/j.jiac.2022.02.027

Cited by 20 publications

(21 citation statements)

References 8 publications

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“…Regarding the reference standard risk of bias, two studies [ 29 , 30 ] had a high risk of bias because the results of the RATs were told to the participants before the rRT-PCR was performed. Unclear risks of applicability concerns were assigned to two studies [ 20 , 31 ] adopting in-house rRT-PCR assays. Under the flow and timing domain, sampling and processing for the index test and reference standard were performed at almost the same time in all the included studies.…”

Section: Resultsmentioning

confidence: 99%

“…In this study based on a living systematic review and meta-analysis, the evidence of the diagnostic utility of RATs without instruments for SARS-CoV-2 variants of concern were combined and compared according to the presence of symptoms. The pooled sensitivity and specificity of RATs for variants from 6904 participants in six studies [ 19 , 20 , 28 , 29 , 30 , 31 ] were 69.7% and 100.0%, respectively. The reported sensitivities of symptomatic patients were higher than those of asymptomatic individuals.…”

Section: Discussionmentioning

confidence: 99%

“…Several reports for the diagnostic utility of RATs for variants showed discrepant results. Some studies showed acceptable performance of RATs for variants [ 19 , 20 ], whereas other studies demonstrated a lower performance of RATs for detecting variants of concern [ 21 , 22 ]. In addition, gene target failures, resulting in false negative results, were reported in commercially available rRT-PCR assays [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Kim

Sung

Lee

et al. 2022

Viruses

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Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Kim

Sung

Lee

et al. 2022

Viruses

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“…A re-evaluation of the QuickNavi-COVID19 Ag test was performed in 1,510 cases during the Delta variant dominantly circulating period in 2021, and the test sensitivity was 88.3% (95% CI: 83%-93%) for symptomatic individuals and 69.4% (95% CI: 60%-78%) for asymptomatic individuals. Three false-positive tests (0.2%) were identified (20). The current study found a slightly better clinical performance for the QuickNavi-COVID19 Ag test during the widespread Omicron circulating period.…”

Section: Discussionmentioning

confidence: 42%

“…Swabs for the antigen test and RT-PCR were obtained separately, and the sample collection procedure for the reference RT-PCR test may have been inappropriate. The flawed procedure may have caused false negatives, which was observed in a previous evaluation [20]. Clinicians should be aware that defective products are a possibility, especially if there are many positive results during a low-prevalence period.…”

Section: Discussionmentioning

confidence: 90%

Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant

Suzuki

Akashi

Kato³

et al. 2022

Preprint

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IntroductionAntigen testing is essential in the clinical management of COVID-19. However, most evaluations of antigen tests have been performed before the emergence of the Omicron variant. Thus, an assessment of the diagnostic performance of antigen tests for the detection of SARS-CoV-2 during the circulation of Omicron variant is required.MethodsThis prospective observational study evaluated QuickNavi-COVID19 Ag, a rapid antigen detection test between December 2021 and February 2022 in Japan, using real-time reverse transcription (RT)-PCR as a reference. Two nasopharyngeal samples were simultaneously collected for antigen testing and for RT-PCR. Variant analysis of the SARS-CoV-2 genomic sequencing was also performed.ResultsIn total, nasopharyngeal samples were collected from 1,073 participants (417 positive; 919 symptomatic; 154 asymptomatic) for analysis. Compared with those of RT-PCR, the sensitivity, specificity, positive predictive value, and negative predictive value were 94.2% (95% CI: 91.6%–96.3%), 99.5% (95% CI: 98.7%–99.9%), 99.2% (95% CI: 97.8%–99.8%), and 96.5% (95% CI: 94.8%–97.7%), respectively. The sensitivity among symptomatic individuals was 94.3% (95% CI: 91.5%–96.4%). Overall, 85.9% of sequences were classified as Omicron sublineage BA.1, 12.4% were Omicron sublineage BA.2, and 1.6% were Delta B.1.617.2. (Delta variant). Most of the samples (87.1%) had Ct values <25.ConclusionsThe QuickNavi-COVID19 Ag test showed high diagnostic performance for the detection of the SARS-CoV-2 Omicron sublineages BA.1 and BA.2 from nasopharyngeal samples.

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Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department

Maldonado-Barrueco,

Gutiérrez-Arroyo,

Bloise

et al. 2024

Eur J Clin Microbiol Infect Dis

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A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag

Cited by 20 publications

References 8 publications

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant

Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department

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