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

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

doi:10.1101/2021.03.03.21252425

Cited by 9 publications

(12 citation statements)

References 14 publications

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“…Furthermore, large-scale screening for SARS-CoV-2 infection demands high specificity to avoid unnecessary further examinations or the application of quarantine measures, which also have social costs [4]. We propose that the QuickNavi™-COVID19 Ag is a reasonable candidate for use in COVID-19 screening tests, given its very high specificity and lack of false-positive results in 2,796 samples (1,934 nasopharyngeal samples in the present study and 862 anterior nasal samples in our previous study [17]). Among the group of samples with Ct values of <30, the QuickNavi™-COVID19 Ag showed a sensitivity of >80% for both symptomatic and asymptomatic subjects.…”

Section: 3%mentioning

confidence: 59%

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

Kiyasu

Takeuchi

Akashi

et al. 2021

Preprint

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Introduction Antigen testing may help screen for and detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in asymptomatic individuals. However, limited data regarding the diagnostic performance of antigen tests for this group are available. Methods We used clinical samples to prospectively evaluate the analytical and clinical performance of the antigen test QuickNavi™-COVID19 Ag. This study was conducted at a PCR center between October 7, 2020 and January 9, 2021. Two nasopharyngeal samples per patient were obtained with flocked swabs; one was used for the antigen test, and the other for real-time reverse transcription PCR (RT-PCR). The diagnostic performance of the antigen test was compared between asymptomatic and symptomatic patients, and the RT-PCR results were used as a reference. Results Among the 1,934 collected samples, SARS-CoV-2 was detected by real-time RT-PCR in 188 (9.7%); 76 (40.4%) of these samples were from asymptomatic individuals. Over half of the total samples (1,073; 55.5%) were obtained from asymptomatic volunteers. The sensitivity of the antigen test was significantly lower for asymptomatic group than for symptomatic patients (67.1% vs 89.3%, p < 0.001). The specificity was 100% for both groups, and no false positives were observed among all 1,934 samples. The median Ct value for the asymptomatic group was significantly higher than that of the symptomatic group (24 vs 20, p < 0.001). Conclusions The QuickNavi™-COVID19 Ag showed a lower sensitivity for asymptomatic group than for symptomatic patients. However, its specificity was consistently high, and no false positives were found in this study.

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Section: 3%mentioning

confidence: 59%

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

Kiyasu

Takeuchi

Akashi

et al. 2021

Preprint

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“…Third, we did not evaluate saliva or anterior nasal cavity samples. Saliva collection and anterior nasal swabs cause less pain and coughing than nasopharyngeal swabs [18]. Future studies should compare the diagnostic performance of samples obtained using each of these methods.…”

Section: Discussionmentioning

confidence: 99%

The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2

Kurihara

Kiyasu

Akashi

et al. 2021

Preprint

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Introduction Rapid antigen tests are convenient for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); however, they have lower sensitivities than nucleic acid amplification tests. In this study, we evaluated the diagnostic performance of Quick Chaser Auto SARS-CoV-2, a novel digital immunochromatographic assay that is expected to have higher sensitivity than conventional antigen tests. Methods A prospective observational study was conducted between February 8 and March 24, 2021. We simultaneously obtained two nasopharyngeal samples, one for evaluation with the QuickChaser Auto SARS-CoV-2 antigen test and the other for assessment with reverse transcription PCR (RT-PCR), considered the gold-standard reference test. The limit of detection (LOD) of the new antigen test was compared with those of four other commercially available rapid antigen tests. Results A total of 1401 samples were analyzed. SARS-CoV-2 was detected by reference RT-PCR in 83 (5.9%) samples, of which 36 (43.4%) were collected from symptomatic patients. The sensitivity, specificity, positive predictive value, and negative predictive value were 74.7% (95% confidence interval (CI): 64.0-83.6%), 99.8% (95% CI: 99.5-100%), 96.9% (95% CI: 89.2-99.6%), and 98.4% (95% CI: 97.6-99.0%), respectively. When limited to samples with a cycle threshold (Ct) <30 or those from symptomatic patients, the sensitivity increased to 98.3% and 88.9%, respectively. The QuickChaser Auto SARS-CoV-2 detected 34-120 copies/test, which indicated greater sensitivity than the other rapid antigen tests. Conclusions QuickChaser Auto SARS-CoV-2 showed sufficient sensitivity and specificity in clinical samples of symptomatic patients. The sensitivity was comparable to RT-PCR in samples with Ct<30.

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“…Der Naseninnenraum wird jedoch nach oben hin wesentlich enger und spaltförmig (rima olfactoria). Der Abstrichtupfer soll etwa 15 s am Ort verbleiben und mehrfach rotiert werden [3,4,[9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: Rachenabstrichunclassified

Der Nasen- oder Rachenabstrich in der COVID-19-Pandemie – Aspekte für den HNO-Arzt/die HNO-Ärztin – SARS-CoV-2, Coronavirus, Nasenabstrich, Rachenabstrich, Komplikationen

Deitmer

Dietz

Chaberny

et al. 2021

Laryngorhinootologie

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ZusammenfassungSeit Beginn der SARS-CoV-2-Pandemie werden zunehmend Abstriche oder andere Beprobungen aus dem oberen Aerodigestivtrakt genommen, da hier vor allen Dingen in frühen Erkrankungsstadien hohe Viruslasten bestehen. Als diagnostische Möglichkeiten sind Abstriche aus der vorderen Nase, dem Nasopharynx oder dem Oropharynx sowie die Gewinnung von Rachenspülwasser oder Speichel möglich. Als Labormethoden stehen in einigen Minuten ablesbare Antigentests oder langwierigere RT-PCR-Methoden zur Verfügung. Abstriche werden von ärztlichem Personal, medizinischem Fachpersonal, Laien und im Eigentest, jeweils nach Instruktionen, durchgeführt. Auf die Aussagekraft und die Sensitivität des gesamten diagnostischen Prozesses haben somit viele dieser Faktoren einen Einfluss. Die PCR-Labormethode ist sensitiver als die Antigenmethode; der Abstrich aus dem Nasopharynx wird als der valideste Abstrichort angesehen. Eine korrekte Durchführung eines Tests kann auch bei nicht professionellen Personen mit guten Instruktionen erreicht werden. Komplikationen werden bei solchen Abstrichen, gemessen an der anzunehmenden Anzahl durchgeführter Prozeduren, sehr selten berichtet. Kurzfristiges Nasenbluten bei traumatischen Abstrichen ist anzunehmen, ohne dass darüber Publikationen aufgefunden werden konnten. Abgebrochene Abstrichträger mussten HNO-ärztlich entfernt werden. Verletzungen der Schädelbasis mit Liquorrhö wurden bisher sehr vereinzelt berichtet, davon 2-mal bei Anomalien wie Meningozelen. Die Wahl eines geeigneten diagnostischen Mediums hängt von vielen Parametern, wie Verfügbarkeit, zeitlicher Ablauf bis zum Ergebnis, Abstrich durch kundiges Personal oder Eigentest und etlichen anderen praktischen Erwägungen, ab.

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

Cited by 9 publications

References 14 publications

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

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

The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2

Der Nasen- oder Rachenabstrich in der COVID-19-Pandemie – Aspekte für den HNO-Arzt/die HNO-Ärztin – SARS-CoV-2, Coronavirus, Nasenabstrich, Rachenabstrich, Komplikationen

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