Evaluation of an Immunochromatography-based Rapid Antigen Test, Inspecter Kowa® SARS-CoV-2, Using Saliva Specimens for the Detection of SARS-CoV-2

Overview

Journal J Infect Chemother

Publisher Elsevier

Specialties Infectious Diseases
Microbiology
Pharmacology

Date 2023 Feb 27

PMID 36849098

Authors

Masahiro Kodana

Yuta Orihara

Mariko Tezuka

Rina Takahashi

Sakiko Noguchi

Nanako Matsuzaki

Tomohito Takada

Naomi Kobari

Kana Ogane

Rieko Kawamura

Toru Kawamura

Shinichi Takeuchi

Yuki Kamiyama

Rie Shiomi

Ryutaro Aoyagi

Masaya Saito

Takeru Kusano

Nobuaki Nakaya

Satoru Kaneko

Hideo Morita

Yoshihito Uchida

Hiroaki Yazawa

Ryu Sekiya

Kazuki Katayama

Shingo Mikami

Tomoya Sato

Norihito Tarumoto

Takehito Kobayashi

Hidetomo Nakamoto

Takuya Maeda

Affiliations

Soon will be listed here.

Abstract

Background: In the context of the coronavirus disease 2019 (COVID-19) pandemic, a rapid and reliable point-of-care test is an essential tool for controlling the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In particular, an immunochromatography test (ICT) that uses saliva specimens for rapid antigen detection not only reduces the risk of secondary infections but also reduces the burden on medical personnel.

Methods: The newly developed salivary antigen test kit "Inspecter Kowa® SARS-CoV-2" is an ICT to which saliva specimens can be directly applied. We evaluated its usefulness in comparison with reverse transcription quantitative PCR (RT-qPCR) and the Espline® SARS-CoV-2 Kit for the detection of SARS-CoV-2 using nasopharyngeal swab specimens. In this study, 140 patients with suspected symptomatic COVID-19 who visited our hospital were enrolled, and nasopharyngeal swab and saliva specimens were collected after they consented to participate in the study.

Results: Inspector Kowa SARS-CoV-2 was positive in 45 of 61 (73.8%) saliva that were positive by RT-qPCR and the Espline® SARS-CoV-2 Kit was also positive in 56 of 60 (93.3%) Np swabs that were positive by RT-qPCR. Good antigen detection was achieved by ICT with saliva and nasopharyngeal swab specimens when viral load was ≥10 copies/mL, whereas detection sensitivity was low when viral load was <10 copies/mL, especially in saliva specimens.

Conclusion: This ICT for the detection of SARS-CoV-2 salivary antigen is an attractive tool that does not require specialized equipment and allows patients to perform the entire process from sample collection to self-diagnose and to reduce the burden on medical care during a pandemic.

References

Al Suwaidi H, Senok A, Varghese R, Deesi Z, Khansaheb H, Pokasirakath S . Saliva for molecular detection of SARS-CoV-2 in school-age children. Clin Microbiol Infect. 2021; 27(9):1330-1335. PMC: 7894096. DOI: 10.1016/j.cmi.2021.02.009. View

De Marinis Y, Pesola A, Soderlund Strand A, Norman A, Pernow G, Alden M . Detection of SARS-CoV-2 by rapid antigen tests on saliva in hospitalized patients with COVID-19. Infect Ecol Epidemiol. 2021; 11(1):1993535. PMC: 8567870. DOI: 10.1080/20008686.2021.1993535. View

Wyllie A, Fournier J, Casanovas-Massana A, Campbell M, Tokuyama M, Vijayakumar P . Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2. N Engl J Med. 2020; 383(13):1283-1286. PMC: 7484747. DOI: 10.1056/NEJMc2016359. View

Shirato K, Nao N, Katano H, Takayama I, Saito S, Kato F . Development of Genetic Diagnostic Methods for Detection for Novel Coronavirus 2019(nCoV-2019) in Japan. Jpn J Infect Dis. 2020; 73(4):304-307. DOI: 10.7883/yoken.JJID.2020.061. View

Korber B, Fischer W, Gnanakaran S, Yoon H, Theiler J, Abfalterer W . Tracking Changes in SARS-CoV-2 Spike: Evidence that D614G Increases Infectivity of the COVID-19 Virus. Cell. 2020; 182(4):812-827.e19. PMC: 7332439. DOI: 10.1016/j.cell.2020.06.043. View

Aoki K, Nagasawa T, Ishii Y, Yagi S, Kashiwagi K, Miyazaki T . Evaluation of clinical utility of novel coronavirus antigen detection reagent, Espline® SARS-CoV-2. J Infect Chemother. 2021; 27(2):319-322. PMC: 7757343. DOI: 10.1016/j.jiac.2020.11.015. View

Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z . SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020; 382(12):1177-1179. PMC: 7121626. DOI: 10.1056/NEJMc2001737. View

Allicock O, Petrone M, Yolda-Carr D, Breban M, Walsh H, Watkins A . Evaluation of saliva self-collection devices for SARS-CoV-2 diagnostics. BMC Infect Dis. 2022; 22(1):284. PMC: 8953967. DOI: 10.1186/s12879-022-07285-7. View

Alkhateeb K, Cahill M, Ross A, Arnold F, Snyder J . The reliability of saliva for the detection of SARS-CoV-2 in symptomatic and asymptomatic patients: Insights on the diagnostic performance and utility for COVID-19 screening. Diagn Microbiol Infect Dis. 2021; 101(3):115450. PMC: 8180088. DOI: 10.1016/j.diagmicrobio.2021.115450. View

10.

Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T . Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19. J Clin Microbiol. 2020; 58(9). PMC: 7448663. DOI: 10.1128/JCM.01438-20. View

11.

Kobayashi R, Murai R, Moriai M, Nirasawa S, Yonezawa H, Kondoh T . Evaluation of false positives in the SARS-CoV-2 quantitative antigen test. J Infect Chemother. 2021; 27(10):1477-1481. PMC: 8226058. DOI: 10.1016/j.jiac.2021.06.019. View

12.

Akashi Y, Kiyasu Y, Takeuchi Y, Kato D, Kuwahara M, Muramatsu S . Evaluation and clinical implications of the time to a positive results of antigen testing for SARS-CoV-2. J Infect Chemother. 2021; 28(2):248-251. PMC: 8577995. DOI: 10.1016/j.jiac.2021.10.026. View

13.

Patriquin G, LeBlanc J, Williams C, Hatchette T, Ross J, Barrett L . Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer. Microbiol Spectr. 2022; 10(1):e0245521. PMC: 8849095. DOI: 10.1128/spectrum.02455-21. View

14.

Jayakody H, Kiddle G, Perera S, Tisi L, Leese H . Molecular diagnostics in the era of COVID-19. Anal Methods. 2021; 13(34):3744-3763. DOI: 10.1039/d1ay00947h. View

15.

Challen R, Brooks-Pollock E, Read J, Dyson L, Tsaneva-Atanasova K, Danon L . Risk of mortality in patients infected with SARS-CoV-2 variant of concern 202012/1: matched cohort study. BMJ. 2021; 372:n579. PMC: 7941603. DOI: 10.1136/bmj.n579. View

16.

Pekosz A, Parvu V, Li M, Andrews J, Manabe Y, Kodsi S . Antigen-Based Testing but Not Real-Time Polymerase Chain Reaction Correlates With Severe Acute Respiratory Syndrome Coronavirus 2 Viral Culture. Clin Infect Dis. 2021; 73(9):e2861-e2866. PMC: 7929138. DOI: 10.1093/cid/ciaa1706. View

17.

Kodana M, Kitagawa Y, Takahashi R, Matsuoka M, Fushimi N, Sakai J . Concerns about the clinical usefulness of saliva specimens for the diagnosis of COVID-19. J Infect. 2021; 83(1):119-145. PMC: 8051001. DOI: 10.1016/j.jinf.2021.04.007. View

18.

Sakanashi D, Asai N, Nakamura A, Miyazaki N, Kawamoto Y, Ohno T . Comparative evaluation of nasopharyngeal swab and saliva specimens for the molecular detection of SARS-CoV-2 RNA in Japanese patients with COVID-19. J Infect Chemother. 2020; 27(1):126-129. PMC: 7524660. DOI: 10.1016/j.jiac.2020.09.027. View

19.

Sohn Y, Jeong S, Chung W, Hyun J, Baek Y, Cho Y . Assessing Viral Shedding and Infectivity of Asymptomatic or Mildly Symptomatic Patients with COVID-19 in a Later Phase. J Clin Med. 2020; 9(9). PMC: 7563591. DOI: 10.3390/jcm9092924. View