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Clinical evaluation of STANDARD Q COVID-19 Ag Test

Minimal risk, single-visit, cross-sectional study of STANDARD Q COVID- 19 Ag test compared to RT-PCR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028774
Enrollment
500
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

None listed

Sponsors

SD Biosensor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Samples are found SARS- CoV-2 negative with reference assay. - The subject is enrolled when â??Essential information for the specimenâ?? is permitted and [SDBCIP_ QCAG1-1] Rev.00 Page 6 / 8 provided consent for enrollment in the study

Exclusion criteria

Exclusion criteria: Obstruction of 1 or more nares - Any condition that in the judgment of the investigator precludes participation because it could adversely affect subject safety or data integrity.

Design outcomes

Primary

MeasureTime frame
Interpretation of test results of STANDARD Q COVID-19 Ag TestTimepoint: days 0-3 more than 40 days 4-7 more than 40 days 7 more than 20—

Secondary

MeasureTime frame
Interpretation of test results of reference methodTimepoint: days 0-3 more than 40 days 4-7 more than 40 days 7 more than 20—

Countries

India

Contacts

Public ContactDr Niraj Kothari

Gujarat Pathology Laboratory & Diagnostic Center

drniraj_patho09@yahoo.in079-26586480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026