Clinical evaluation of self-collected saliva by RT-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19
Abstract Background The clinical performance 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.Methods 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 polymerase chain reaction (RT-qPCR) laboratory-developed tes (LDT), a cobas SARS-CoV-2 high-throughput system, three direct RT-qPCR kits, and reverse-transcription loop mediated isothermal amplification (RT-LAMP). Viral antigen was detected by a rapid antigen immunochromatographic assay.Results Of the 103 samples, viral RNA was detected in 50.5–81.6% 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 a significantly higher percentage (65.6–93.4%) in specimens collected within 9 d of symptom onset compared to that of specimens collected after at least 10 d of symptom onset (22.2–66.7%) and that of asymptomatic patients (40.0–66.7%). Viral RNA was more frequently detected in saliva from males than females.Conclusions Self-collected saliva is an alternative specimen diagnosing COVID-19. LDT RT-qPCR, cobas SARS-CoV-2 high-throughput system, direct RT-qPCR except for one commercial kit, and RT-LAMP showed sufficient sensitivity in clinical use to be selectively used according to clinical settings and facilities. The rapid antigen test alone is not recommended for initial COVID-19 diagnosis because of its low sensitivity.Key points Six molecular diagnostic tests showed equivalent and sufficient sensitivity in clinical use in diagnosing COVID-19 in self-collected saliva samples. However, a rapid SARS-CoV-2 antigen test alone is not recommended for use without further study..
| Medienart: |
|
|---|
Preprint| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
bioRxiv.org - (2020) vom: 30. Dez. Zur Gesamtaufnahme - year:2020 |
|---|
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Ikeda, Mayu [VerfasserIn] |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| doi: |
10.1101/2020.06.06.20124123 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
XBI018086942 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | XBI018086942 | ||
| 003 | DE-627 | ||
| 005 | 20230429100910.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 200610s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1101/2020.06.06.20124123 |2 doi | |
| 035 | |a (DE-627)XBI018086942 | ||
| 035 | |a (DE-599)biorXiv10.1101/2020.06.06.20124123 | ||
| 035 | |a (biorXiv)10.1101/2020.06.06.20124123 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 082 | 0 | |a 570 |q DE-84 | |
| 100 | 1 | |a Ikeda, Mayu |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical evaluation of self-collected saliva by RT-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19 |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a Abstract Background The clinical performance 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.Methods 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 polymerase chain reaction (RT-qPCR) laboratory-developed tes (LDT), a cobas SARS-CoV-2 high-throughput system, three direct RT-qPCR kits, and reverse-transcription loop mediated isothermal amplification (RT-LAMP). Viral antigen was detected by a rapid antigen immunochromatographic assay.Results Of the 103 samples, viral RNA was detected in 50.5–81.6% 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 a significantly higher percentage (65.6–93.4%) in specimens collected within 9 d of symptom onset compared to that of specimens collected after at least 10 d of symptom onset (22.2–66.7%) and that of asymptomatic patients (40.0–66.7%). Viral RNA was more frequently detected in saliva from males than females.Conclusions Self-collected saliva is an alternative specimen diagnosing COVID-19. LDT RT-qPCR, cobas SARS-CoV-2 high-throughput system, direct RT-qPCR except for one commercial kit, and RT-LAMP showed sufficient sensitivity in clinical use to be selectively used according to clinical settings and facilities. The rapid antigen test alone is not recommended for initial COVID-19 diagnosis because of its low sensitivity.Key points Six molecular diagnostic tests showed equivalent and sufficient sensitivity in clinical use in diagnosing COVID-19 in self-collected saliva samples. However, a rapid SARS-CoV-2 antigen test alone is not recommended for use without further study. | ||
| 700 | 1 | |a Imai, Kazuo |e verfasserin |4 aut | |
| 700 | 1 | |a Tabata, Sakiko |e verfasserin |4 aut | |
| 700 | 1 | |a Miyoshi, Kazuyasu |e verfasserin |4 aut | |
| 700 | 1 | |a Murahara, Nami |e verfasserin |4 aut | |
| 700 | 1 | |a Mizuno, Tsukasa |e verfasserin |4 aut | |
| 700 | 1 | |a Horiuchi, Midori |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Kento |e verfasserin |4 aut | |
| 700 | 1 | |a Imoto, Yoshitaka |e verfasserin |4 aut | |
| 700 | 1 | |a Iwata, Maki |e verfasserin |4 aut | |
| 700 | 1 | |a Mimura, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ito, Toshimitsu |e verfasserin |4 aut | |
| 700 | 1 | |a Tamura, Kaku |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Yasuyuki |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t bioRxiv.org |g (2020) vom: 30. Dez. |
| 773 | 1 | 8 | |g year:2020 |g day:30 |g month:12 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1101/2020.06.06.20124123 |z kostenfrei |3 Volltext |
| 912 | |a GBV_XBI | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2020 |b 30 |c 12 | ||
| 953 | |2 045F |a 570 | ||