Clinical Performance Verification Study of "COVID-19 Ag Rapid Saliva Test Device" for Diagnostic Aid of SARS-CoV-2 Infection

Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device" - Clinical Performance Study of "COVID-19 Ag Rapid Saliva Test Device"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049723

Enrollment

120

Registered

2022-12-19

Start date

2022-12-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

COVID-19

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with symptoms include fever (37.5 degrees C or higher) or sore throat and cough who are suspected of having the COVID-19, or may be infected.

Exclusion criteria

Exclusion criteria: Patients with symptoms for more than ten days. Patients with an invalid test result. Patients who could not collect saliva needed for testing.

Design outcomes

Primary

Measure	Time frame
Positive percent agreement, Negative percent agreement and Overall percent agreement are all not lower than 90 percent.	—

Countries

Japan

Contacts

Public ContactKenji Kobayashi

Tokyo Heart Center Pharmaceutical Dep. / Medical Technology Dep.

pkobayashi@tokyoheart.or.jp03-5789-8100

Outcome results