Tags

Type your tag names separated by a space and hit enter

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 08 24; 58(9)JC

Abstract

The clinical performances of six molecular diagnostic tests and a rapid antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were clinically evaluated for the diagnosis of coronavirus disease 2019 (COVID-19) in self-collected saliva. Saliva samples from 103 patients with laboratory-confirmed COVID-19 (15 asymptomatic and 88 symptomatic) were collected on the day of hospital admission. SARS-CoV-2 RNA in saliva was detected using a quantitative reverse transcription-PCR (RT-qPCR) laboratory-developed test (LDT), a cobas SARS-CoV-2 high-throughput system, three direct RT-qPCR kits, and reverse transcription-loop-mediated isothermal amplification (RT-LAMP). The viral antigen was detected by a rapid antigen immunochromatographic assay. Of the 103 samples, viral RNA was detected in 50.5 to 81.6% of the specimens by molecular diagnostic tests, and an antigen was detected in 11.7% of the specimens by the rapid antigen test. Viral RNA was detected at significantly higher percentages (65.6 to 93.4%) in specimens collected within 9 days of symptom onset than in specimens collected after at least 10 days of symptoms (22.2 to 66.7%) and in specimens collected from asymptomatic patients (40.0 to 66.7%). Self-collected saliva is an alternative specimen option for diagnosing COVID-19. The RT-qPCR LDT, a cobas SARS-CoV-2 high-throughput system, direct RT-qPCR kits (except for one commercial kit), and RT-LAMP showed sufficient sensitivities in clinical use to be selectively used in clinical settings and facilities. The rapid antigen test alone is not recommended for an initial COVID-19 diagnosis because of its low sensitivity.

Authors+Show Affiliations

Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan k_imai@saitama-med.ac.jp. Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Self-Defense Forces Central Hospital, Tokyo, Japan.Department of Infectious Diseases, International University of Health and Welfare Narita Hospital, Chiba, Japan.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32636214

Citation

Nagura-Ikeda, Mayu, et al. "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." Journal of Clinical Microbiology, vol. 58, no. 9, 2020.
Nagura-Ikeda M, Imai K, Tabata S, et al. 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).
Nagura-Ikeda, M., Imai, K., Tabata, S., Miyoshi, K., Murahara, N., Mizuno, T., Horiuchi, M., Kato, K., Imoto, Y., Iwata, M., Mimura, S., Ito, T., Tamura, K., & Kato, Y. (2020). 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. Journal of Clinical Microbiology, 58(9). https://doi.org/10.1128/JCM.01438-20
Nagura-Ikeda M, et al. 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 08 24;58(9) PubMed PMID: 32636214.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Nagura-Ikeda,Mayu, AU - Imai,Kazuo, AU - Tabata,Sakiko, AU - Miyoshi,Kazuyasu, AU - Murahara,Nami, AU - Mizuno,Tsukasa, AU - Horiuchi,Midori, AU - Kato,Kento, AU - Imoto,Yoshitaka, AU - Iwata,Maki, AU - Mimura,Satoshi, AU - Ito,Toshimitsu, AU - Tamura,Kaku, AU - Kato,Yasuyuki, Y1 - 2020/08/24/ PY - 2020/06/08/received PY - 2020/07/03/accepted PY - 2020/7/9/pubmed PY - 2020/9/9/medline PY - 2020/7/9/entrez KW - RT-LAMP KW - RT-qPCR KW - SARS-CoV-2 KW - antigen test KW - saliva JF - Journal of clinical microbiology JO - J. Clin. Microbiol. VL - 58 IS - 9 N2 - The clinical performances of six molecular diagnostic tests and a rapid antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were clinically evaluated for the diagnosis of coronavirus disease 2019 (COVID-19) in self-collected saliva. Saliva samples from 103 patients with laboratory-confirmed COVID-19 (15 asymptomatic and 88 symptomatic) were collected on the day of hospital admission. SARS-CoV-2 RNA in saliva was detected using a quantitative reverse transcription-PCR (RT-qPCR) laboratory-developed test (LDT), a cobas SARS-CoV-2 high-throughput system, three direct RT-qPCR kits, and reverse transcription-loop-mediated isothermal amplification (RT-LAMP). The viral antigen was detected by a rapid antigen immunochromatographic assay. Of the 103 samples, viral RNA was detected in 50.5 to 81.6% of the specimens by molecular diagnostic tests, and an antigen was detected in 11.7% of the specimens by the rapid antigen test. Viral RNA was detected at significantly higher percentages (65.6 to 93.4%) in specimens collected within 9 days of symptom onset than in specimens collected after at least 10 days of symptoms (22.2 to 66.7%) and in specimens collected from asymptomatic patients (40.0 to 66.7%). Self-collected saliva is an alternative specimen option for diagnosing COVID-19. The RT-qPCR LDT, a cobas SARS-CoV-2 high-throughput system, direct RT-qPCR kits (except for one commercial kit), and RT-LAMP showed sufficient sensitivities in clinical use to be selectively used in clinical settings and facilities. The rapid antigen test alone is not recommended for an initial COVID-19 diagnosis because of its low sensitivity. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32636214/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_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32636214 DB - PRIME DP - Unbound Medicine ER -