Clinical availability of bean extract-based gargle for SARS-CoV-2 antigen rapid detection test and RT-PCR

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006438

Enrollment

200

Registered

2021-08-12

Start date

2021-05-07

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Bean extract based gargle) : Medical professionals collected NPS specimens as a reference from participants and saliva specimens by asking participants to spit into a tube after swirling and ga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (a) Adults aged 18 years or above (i) Patients hospitalized with COVID-19 confirmation in the screening center. (ii) Healthy subjects who do not have had contact with confirmed or suspected cases in the two weeks prior to the trial. (b) Agree to participate in this trial and provide written informed consent. (c) Permit the investigator to access the patient's medical records relevant to study procedures. (d) Provide paired NPS and BG-based saliva specimen. Medical professionals collected NPS specimens from participants by spitting into a tube after swirling and gargling 5 mL of BG for 2 min.

Exclusion criteria

Exclusion criteria: (a) Healthy subjects who present a body temperature higher than 37.0º C (b) Healthy subjects who have respiratory symptoms (c) Not willing to provide sufficient BG-based saliva specimen. (d) Not willing to collect NPS specimen.

Design outcomes

Primary

Measure	Time frame
sensitivity, specificity	—

Secondary

Measure	Time frame
negative predictive value, positive predictive value	—

Countries

Korea, Republic of

Contacts

Public ContactNamsu Kim

Jeonbuk National University Hospital

namsu1224@jbnu.ac.kr+82-63-250-1215

Outcome results