Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

Kiyasu, Yoshihiko; Takeuchi, Yuto; Akashi, Yusaku; Kato, Daisuke; Kuwahara, Masaki; Muramatsu, Shino; Notake, Shigeyuki; Ueda, Atsuo; Nakamura, Koji; Ishikawa, Hiroichi; Suzuki, Hiromichi

doi:10.1101/2021.04.01.21254813

Cited by 4 publications

(3 citation statements)

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“…In 4 cases [49,60,65,66], authors reported that the required number of individuals who tested positive or negative by the reference standard was not reached, and in 1 case [56] no data on age were recorded. Eventually, author queries led to the inclusion of 8 further studies [48,50,51,54,61,63,64,67] resulting in a total of 17 relevant studies for this review (12 peer-reviewed journal articles and 5 preprints). The full list of included studies is reported in Table 3 .…”

Section: Resultsmentioning

confidence: 99%

“…CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) 1 1 queries led to the inclusion of 8 further studies [48,50,51,54,61,63,64,67] resulting in a total of 17 relevant studies for this review (12 peer-reviewed journal articles and 5 preprints). The full list of included studies is reported in Table 3.…”

Section: Diagnostic Accuracy Measures and Data Synthesismentioning

confidence: 99%

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Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Fujita-Rohwerder

Beckmann

Zens

et al. 2021

Preprint

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Objective: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions. Study design: Multiple bibliographic databases including MEDLINE and Embase, clinical trial registries and further information sources were systematically searched for literature (last bibliographic search: May 7, 2021). Diagnostic cross-sectional or cohort studies that included paediatric study participants and evaluated rapid point-of care tests for diagnosing current SARS-CoV-2 infections against RT-PCR as the reference standard were eligible for inclusion. QUADAS-2 was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses. Results: We included 17 studies with a total of 6355 paediatric study participants. All included studies compared antigen tests against RT-PCR. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI: 57.4%-70.5%) and 99.1% (95% CI: 98.2%-99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI: 63.6%-78.8%) and the pooled diagnostic specificity was 98.7% (95% CI: 96.6%-99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI: 47.6%-64.4%) and the pooled diagnostic specificity was 98.6% (95% CI: 97.3%-99.3%). Conclusions: Performance of current antigen tests under real-life conditions varies broadly. Policymakers should especially be aware of the low diagnostic sensitivity of current antigen tests. Results should be interpreted with caution since risk of bias was predominantly judged as unclear due to poor reporting. Study Registration: CRD42021236313 (PROSPERO).

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Section: Resultsmentioning

confidence: 99%

Section: Diagnostic Accuracy Measures and Data Synthesismentioning

confidence: 99%

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Fujita-Rohwerder

Beckmann

Zens

et al. 2021

Preprint

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“…The reactivity of antigen tests can differ between clinical and UTM ™ samples. QuickNavi™-COVID19 Ag detected the virus in almost all clinical samples with Ct values <30 when the supplied extraction reagent was used [7,16], but the sensitivity plummeted when samples were diluted in UTM™ [17]. Measuring the limit of detection seems insufficient to verify the clinical performance of antigen tests.…”

Section: Discussionmentioning

confidence: 99%

Evaluation and clinical implications of the time to a positive results of antigen testing for SARS-CoV-2

Akashi

Kiyasu

Takeuchi

et al. 2021

Preprint

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Antigen tests for severe acute respiratory coronavirus 2 sometimes show positive lines earlier than their specified read time, although the implication of getting the results at earlier time is not well understood. This study aimed to evaluate the clinical utility of an antigen test by evaluating the time period to get positive results and by comparing the test sensitivity with that of a digital immunoassay (DIA) test. We prospectively collected additional nasopharyngeal samples from patients who had already tested positive for SARS-CoV-2 by reverse transcription PCR. The additional swab was used for an antigen test, QuickNavi™-COVID19 Ag, and the time periods to get positive results were measured. The sensitivity of QuickNavi™-COVID19 Ag was also compared with that of a DIA. In 84 of 96 (87.5%) analyzed cases, the results of QuickNavi™-COVID19 Ag were positive. The time to obtain positive results was 15.0 seconds in median (inter quartile range: 12.0-33.3, range 11-736), and was extended in samples with higher cycle thresholds (Ct) (p<0.001). Positive lines appeared within a minute in 85.7% of cases and within 5 minutes in 96.4%. The sensitivities of QuickNavi™-COVID19 Ag and the DIA were 87.5% (95% confident interval [CI]: 79.2%-93.4%) and 88.6% (95%CI: 75.4%-96.2%), respectively. Their results were concordant in 90.9% of cases, with discrepancies present only in cases with Ct values >32. QuickNavi™-COVID19 Ag immediately showed positive results in most cases, and the time to a positive reaction may have indicated the viral load. In addition, the sensitivity of the test was comparable to the DIA.

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The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

Brümmer

Katzenschlager

Gaeddert

et al. 2021

Preprint

102

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Background: SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being inte-grated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensi-tivity and specificity) of commercially available Ag-RDTs. Methods: We registered the review on PROSPERO (Registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix and bioRvix, FINDdx) for publications up until December 11th, 2020. Descriptive analyses of all studies were performed and when more than four studies were avail-able, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcriptase polymerase chain reaction testing. We assessed heterogeneity by subgroup analyses ((1) performed conform with manufacturers instructions for use (IFU) or not, (2) symptomatic vs. asymptomatic, (3) duration of symptoms less than seven days vs. more than seven days, (4) Ct-value <25 vs. <30 vs. >30, (5) by sample type)) and with meta-regression. We assessed study quality and risk of bias using the QUADAS 2 assessment tool. Results: From a total of 11,715 articles, we extracted 98 analytical and clinical data sets. 74 clinical accuracy data sets were evaluated that included 31,202 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity was 73.8% (CI 68.6 to 78.5). If analysis was re-stricted to studies that followed the Ag-RDT manufacturers instructions using fresh upper res-piratory swab samples, the sensitivity increased to 79.1% (95%CI 75.0 to 82.8). The SD Biosensor Standard Q and Abbott Panbio showed the highest sensitivity with 81.7% and 72.7%, respectively. The best Ag-RDT performance was found with nasopharyngeal sampling (77.3%, CI 72.0 to 81.9) in comparison to other sample types (e.g., anterior nasal or mid turbinate 63.5%, CI 49.5 to 75.5). Testing in the first week from symptom onset resulted in higher sensitivity (87.5%, CI 86.0 to 89.1) compared to testing after one week (64.1%, CI 54.4 to 73.8). The tests performed markedly better on samples with lower Ct-values, i.e., <30 (87.9%, CI 86.7 to 88.8), in comparison to those with Ct >30 (47.8%, CI 41.1 to 54.5). Bias concerns were raised across all data sets, and financial support from the manufacturer was reported in 28.2% of data sets. Conclusion: As Ag-RDTs detect most cases within the first week of symptom onset and those with high viral load, they can have high utility for screening purposes in the early phase of disease, and thus can be a valuable tool to fight the spread of SARS-CoV-2. Standardization of con-duct and reporting of clinical accuracy studies would improve comparability and use of data.

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Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

Cited by 4 publications

References 20 publications

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Evaluation and clinical implications of the time to a positive results of antigen testing for SARS-CoV-2

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

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