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

Not Applicable

Completed

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

• Registration Number: CTRI/2021/03/031756
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-06-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 121

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of rapid antigen detection kitTimepoint: Once

Secondary Outcome Measures

Name	Time	Method
ot applicableTimepoint: Not applicable