tetano
Editor, Senior Moderator
Int J Infect Dis
. 2022 Sep 16;S1201-9712(22)00517-3.
doi: 10.1016/j.ijid.2022.09.018. Online ahead of print.
Diagnostic accuracy of a novel severe acute respiratory syndrome coronavirus 2 rapid antigen test and usefulness of specimens collected from the anterior nasal cavity
Daisuke Tamura[SUP] 1 [/SUP], Hirokazu Yamagishi[SUP] 2 [/SUP], Yuji Morisawa[SUP] 3 [/SUP], Takashi Mato[SUP] 4 [/SUP], Shin Nunomiya[SUP] 5 [/SUP], Yuta Maehara[SUP] 6 [/SUP], Yasushi Ochiai[SUP] 7 [/SUP], Shinya Okuyama[SUP] 8 [/SUP], Narumi Ohmika[SUP] 9 [/SUP], Takanori Yamagata[SUP] 10 [/SUP], Hitoshi Osaka[SUP] 11 [/SUP]
Affiliations
Abstract
Objectives: We aimed to validate a newly developed antigen-detecting rapid diagnostic test (Ag-RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using anterior nasal specimens.
Methods: Between February 12 and September 30, 2021, 16 patients (age range, <1 month-76 years) were enrolled, and samples were collected simultaneously from anterior nasal and nasopharyngeal sites continuously during hospitalization. The primary endpoints were the diagnostic accuracy of the Ag-RDT and utility of anterior nasal specimens.
Results: In total, 226 sets of paired samples were obtained. In 88.2% of specimens, the viral load was high at the nasopharyngeal site. The mean cycle threshold (Ct) values for the anterior nasal and nasopharyngeal sites were 32.4 and 29.9, respectively. Using the real-time polymerase chain reaction results as a reference, the Ag-RDT showed 100% sensitivity up to day 6 of the illness using specimens with moderate or high viral load (Ct <30) from either site. From day 7, the sensitivity was 70.4-90.6% and 83.9-84.6% for the anterior nasal and nasopharyngeal sites, respectively. The specificity remained at 100%.
Conclusions: Our novel Ag-RDT meets the World Health Organization criteria and provides stable sensitivity and specificity and accurate results with anterior nasal specimens.
Keywords: Nasal mucosa; Real-time polymerase chain reaction; SARS-CoV-2; Viral load.
. 2022 Sep 16;S1201-9712(22)00517-3.
doi: 10.1016/j.ijid.2022.09.018. Online ahead of print.
Diagnostic accuracy of a novel severe acute respiratory syndrome coronavirus 2 rapid antigen test and usefulness of specimens collected from the anterior nasal cavity
Daisuke Tamura[SUP] 1 [/SUP], Hirokazu Yamagishi[SUP] 2 [/SUP], Yuji Morisawa[SUP] 3 [/SUP], Takashi Mato[SUP] 4 [/SUP], Shin Nunomiya[SUP] 5 [/SUP], Yuta Maehara[SUP] 6 [/SUP], Yasushi Ochiai[SUP] 7 [/SUP], Shinya Okuyama[SUP] 8 [/SUP], Narumi Ohmika[SUP] 9 [/SUP], Takanori Yamagata[SUP] 10 [/SUP], Hitoshi Osaka[SUP] 11 [/SUP]
Affiliations
- PMID: 36122672
- DOI: 10.1016/j.ijid.2022.09.018
Abstract
Objectives: We aimed to validate a newly developed antigen-detecting rapid diagnostic test (Ag-RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using anterior nasal specimens.
Methods: Between February 12 and September 30, 2021, 16 patients (age range, <1 month-76 years) were enrolled, and samples were collected simultaneously from anterior nasal and nasopharyngeal sites continuously during hospitalization. The primary endpoints were the diagnostic accuracy of the Ag-RDT and utility of anterior nasal specimens.
Results: In total, 226 sets of paired samples were obtained. In 88.2% of specimens, the viral load was high at the nasopharyngeal site. The mean cycle threshold (Ct) values for the anterior nasal and nasopharyngeal sites were 32.4 and 29.9, respectively. Using the real-time polymerase chain reaction results as a reference, the Ag-RDT showed 100% sensitivity up to day 6 of the illness using specimens with moderate or high viral load (Ct <30) from either site. From day 7, the sensitivity was 70.4-90.6% and 83.9-84.6% for the anterior nasal and nasopharyngeal sites, respectively. The specificity remained at 100%.
Conclusions: Our novel Ag-RDT meets the World Health Organization criteria and provides stable sensitivity and specificity and accurate results with anterior nasal specimens.
Keywords: Nasal mucosa; Real-time polymerase chain reaction; SARS-CoV-2; Viral load.