Clinical evaluation of the rapid nucleic acid amplification point-of-care test (Smart Gene SARS-CoV-2) in the analysis of nasopharyngeal and anterior nasal samples

Kiyasu, Yoshihiko; Owaku, Masato; Akashi, Yusaku; Takeuchi, Yuto; Narahara, Kenji; Mori, Sunao; Nagano, Takashi; Notake, Shigeyuki; Ueda, Atsuo; Nakamura, Koji; Ishikawa, Hiroichi; Suzuki, Hiromichi

doi:10.1016/j.jiac.2021.12.027

Cited by 16 publications

(13 citation statements)

References 13 publications

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“…Nucleic acid puri cation, reverse transcription reaction, and PCR are performed for up to 45 cycles. The sample was de ned positive when the result exceeded the threshold from 23 cycles of PCR [21][22][23].…”

Section: Patient Enrollmentmentioning

confidence: 99%

Retrospective study on the efficacy of monocyte distribution width (MDW) as a screening test for COVID-19

Wakamatsu

Nagasawa

Katsuki

et al. 2022

Preprint

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Purpose: Pathogenic genetic testing for Coronavirus disease 2019 (COVID-19) can detect viruses with high sensitivity, however there are several challenges. In the prevention, testing, and treatment of COVID-19, more effective, safer, and convenient methods are desired. We evaluated the possibility of monocyte distribution width (MDW) as an infection biomarker in COVID-19 testing.Methods: The efficacy of MDW as a screening test for COVID-19 was retrospectively assessed in 80 patients in the COVID-19 group and 232 patients in the Non-COVID-19 group (141 patients with acute respiratory infection, 19 patients with non-respiratory infection, 1 patient with viral infection, 11 patients who had received treatment for COVID-19, 1 patient in contact with COVID-19 patients, and 59 patients with non-infectious disease). Results: The median MDW in 80 patients in the COVID-19 group was 23.3 (17.2-33.6), and the median MDW in 232 patients in the Non-COVID-19 group was 19.0 (13.6-30.2) (P < 0.001). When the COVID-19 group was identified using the MDW cut-off value of 21.3 from the Non-COVID-19 group, the area under the curve (AUC) was 0.844, and the sensitivity and specificity were 81.3% and 78.2%, respectively. Comparison of MDW by severity between the COVID-19 group and patients with acute respiratory infection in the Non-COVID-19 group showed that MDW was significantly higher in the COVID-19 group for all of mild, moderate I, and moderate II disease. Conclusions: MDW (cut-off value: 21.3) may be used as a screening test for COVID-19 in fever outpatients, etc.

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Section: Patient Enrollmentmentioning

confidence: 99%

Retrospective study on the efficacy of monocyte distribution width (MDW) as a screening test for COVID-19

Wakamatsu

Nagasawa

Katsuki

et al. 2022

Preprint

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“…NP and saliva samples were simultaneously obtained from participants. The sample collection was performed as previously described [2,[8][9][10][11][12][13][14][15][16][17][18][19]. All antigen tests for saliva were immediately performed on site after sample collection.…”

Section: Study Processmentioning

confidence: 99%

A prospective evaluation of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 in Japan

Terada

Akashi

Takeuchi

et al. 2022

Preprint

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Introduction: Rapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated. Methods: A prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva between June 2022 and July 2022 in Japan using real-time reverse transcription polymerase chain reaction (RT-PCR) as a reference. A nasopharyngeal sample and a saliva sample were simultaneously obtained, and RT-PCR was performed. Results: In total, saliva samples and nasopharyngeal samples were collected from 471 participants (140 RT-PCR-positive saliva samples and 143 RT-PCR-positive nasopharyngeal samples) for the analysis. The median Ct values were 25.5 (interquartile range [IQR]: 21.9-28.8) for saliva samples and 17.1 (IQR: 15.5-18.7) for nasopharyngeal samples (p<0.001). Compared with saliva samples of RT-PCR, the sensitivity and specificity were 46.4% and 99.7% for ImunoAce SARS-CoV-2 Saliva, 59.3% and 99.1% for Espline SARS-CoV-2 N, and 61.4% and 98.8% for QuickChaser Auto SARS-CoV-2, respectively. The sensitivity is >90% for saliva samples with a moderate-to-high viral load (Ct<25), whereas the sensitivity is <70% for high-viral-load nasopharyngeal samples (Ct<20). Conclusion: COVID-19 rapid antigen detection kits with saliva showed high specificities, but the sensitivities varied among kits, and the analytical performance of saliva qualitative antigen detection kits was much worse than that of kits using nasopharyngeal samples.

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“…Two nasopharyngeal samples were separately collected by medical professionals one for RT-PCR and the other for antigen testing, as previously described [ [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] ]. A nasopharyngeal sample was obtained from each nasal cavity.…”

Section: Introductionmentioning

confidence: 99%

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

Suzuki¹,

Akashi²,

Kato³

et al. 2023

Journal of Infection and Chemotherapy

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Clinical evaluation of the rapid nucleic acid amplification point-of-care test (Smart Gene SARS-CoV-2) in the analysis of nasopharyngeal and anterior nasal samples

Cited by 16 publications

References 13 publications

Retrospective study on the efficacy of monocyte distribution width (MDW) as a screening test for COVID-19

Retrospective study on the efficacy of monocyte distribution width (MDW) as a screening test for COVID-19

A prospective evaluation of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 in Japan

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

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