tetano
Editor, Senior Moderator
J Infect Chemother
. 2024 Mar 2:S1341-321X(24)00073-4.
doi: 10.1016/j.jiac.2024.02.032. Online ahead of print. Clinical evaluation of a modified SARS-CoV-2 rapid molecular assay, ID NOW ™ COVID-19 2.0
Yu Arakawa[SUP] 1 [/SUP], Yoshie Nishida[SUP] 2 [/SUP], Daisuke Sakanashi[SUP] 3 [/SUP], Akiko Nakamura[SUP] 3 [/SUP], Hirotoshi Ota[SUP] 3 [/SUP], Shinji Tokuhiro[SUP] 4 [/SUP], Hiroshige Mikamo[SUP] 5 [/SUP], Yuka Yamagishi[SUP] 6 [/SUP]
Affiliations
In the diagnosis of coronavirus disease 2019 (COVID-19), several types of instruments and reagents for SARS-CoV-2 nucleic acid testing have been introduced to meet clinical needs. We evaluated the clinical performances of ID NOW™ COVID-19 2.0 (ID NOW™ 2.0), which is capable of detecting SARS-CoV-2 within 12 min as part of point-of-care testing (POCT). Patients who displayed COVID-19 related symptoms, and who were tested for screening purposes, were recruited to this study. Two nasopharyngeal swabs were collected and tested using the ID NOW™ 2.0 test. Reference testing was performed using the cobas 8800 or 6800 (reagents: cobas SARS-CoV-2 and Flu A/B). A total of 38 samples and 46 samples were tested positive and negative, respectively, by the reference test. The ID NOW™ 2.0 showed a sensitivity of 94.7% (95% CI: 82.3-99.4) and a specificity of 100% (95% CI: 92.3-100). Samples that were positive by reference testing had cycle threshold (Ct) values ranging from 11.90 to 35.41. Among these reference positive samples, two samples were negative by ID NOW™ 2.0 with Ct values of 35.25 and 35.41. For samples with Ct values < 35, the sensitivity of ID NOW™ 2.0 was 100%. In Japan, the restrictions related to COVID-19 have been relaxed, however the COVID-19 epidemic still continues. ID NOW™ 2.0 is expected to be used as a rapid and reliable alternative to laboratory-based RT-PCR methods.
Keywords: Coronavirus disease 2019 (COVID-19); ID NOW; Nucleic acid test; Rapid molecular test; SARS-CoV-2.
. 2024 Mar 2:S1341-321X(24)00073-4.
doi: 10.1016/j.jiac.2024.02.032. Online ahead of print. Clinical evaluation of a modified SARS-CoV-2 rapid molecular assay, ID NOW ™ COVID-19 2.0
Yu Arakawa[SUP] 1 [/SUP], Yoshie Nishida[SUP] 2 [/SUP], Daisuke Sakanashi[SUP] 3 [/SUP], Akiko Nakamura[SUP] 3 [/SUP], Hirotoshi Ota[SUP] 3 [/SUP], Shinji Tokuhiro[SUP] 4 [/SUP], Hiroshige Mikamo[SUP] 5 [/SUP], Yuka Yamagishi[SUP] 6 [/SUP]
Affiliations
- PMID: 38437982
- DOI: 10.1016/j.jiac.2024.02.032
In the diagnosis of coronavirus disease 2019 (COVID-19), several types of instruments and reagents for SARS-CoV-2 nucleic acid testing have been introduced to meet clinical needs. We evaluated the clinical performances of ID NOW™ COVID-19 2.0 (ID NOW™ 2.0), which is capable of detecting SARS-CoV-2 within 12 min as part of point-of-care testing (POCT). Patients who displayed COVID-19 related symptoms, and who were tested for screening purposes, were recruited to this study. Two nasopharyngeal swabs were collected and tested using the ID NOW™ 2.0 test. Reference testing was performed using the cobas 8800 or 6800 (reagents: cobas SARS-CoV-2 and Flu A/B). A total of 38 samples and 46 samples were tested positive and negative, respectively, by the reference test. The ID NOW™ 2.0 showed a sensitivity of 94.7% (95% CI: 82.3-99.4) and a specificity of 100% (95% CI: 92.3-100). Samples that were positive by reference testing had cycle threshold (Ct) values ranging from 11.90 to 35.41. Among these reference positive samples, two samples were negative by ID NOW™ 2.0 with Ct values of 35.25 and 35.41. For samples with Ct values < 35, the sensitivity of ID NOW™ 2.0 was 100%. In Japan, the restrictions related to COVID-19 have been relaxed, however the COVID-19 epidemic still continues. ID NOW™ 2.0 is expected to be used as a rapid and reliable alternative to laboratory-based RT-PCR methods.
Keywords: Coronavirus disease 2019 (COVID-19); ID NOW; Nucleic acid test; Rapid molecular test; SARS-CoV-2.