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A study to investigate the performance of the rapid antigen test kit for detecting the SARs-CoV2 coronavirus.

AN OPEN LABEL, SINGLE CENTRE STUDY TO EVALUATE THE PERFOMANCE OF THE RAPID ANTIGEN TEST KIT USING NASO-PHARYNGEAL / OROPHARYNGEAL SWAB IN COVID-19 (SARS-CoV2)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/031756
Enrollment
100
Registered
2021-03-08
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

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A voluntarily given data sharing consent from subjects and/or from legally acceptable representative (in case subject is not conscious and oriented). 2. Subjects of 18 years and above with suspected COVID 19 symptoms. 3. No previous or experimental treatment for pneumonia associated with a novel coronavirus infection.

Exclusion criteria

Exclusion criteria: 1. Subjects with history of diseases that need to be distinguished from new coronavirus infection pneumonia, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic pneumonia. 2. Subjects with blood in their sputum or saliva. 3. The investigator determines that the subject is not appropriate to participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of rapid antigen detection kitTimepoint: Once

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd

Sandesh.Sawant3@Cipla.com02223025188

Outcome results

None listed

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