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A new test to diagnose COVID-19

Validation of the TataMD CHECK CRISPR SARS-CoV-2 test 1.0 for the diagnosis of COVID-19

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/030950
Enrollment
150
Registered
2021-02-03
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

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Tata Medical and Diagnostics Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: RNA extracted from stored viral transport media (VTM) containing nasopharyngeal and/or oropharyngeal swabs submitted for testing for SARS CoV-2

Exclusion criteria

Exclusion criteria: Nil

Design outcomes

Primary

MeasureTime frame
Sensitivity of TataMD CHECK CRISPR SARS-CoV-2 test 1.0 compared to real time RT-PCRTimepoint: 0 hours

Secondary

MeasureTime frame
Accuracy of TataMD CHECK CRISPR SARS-CoV-2 test 1.0 compared to real time RT-PCR.Timepoint: 0 hours;Agreement between TataMD CHECK manual readings on the TataMD CHECK CRISPR SARS-CoV-2 test 1.0 kit versus TataMD CHECK application resultsTimepoint: 0 hours;Specificity of the TataMD CHECK CRISPR SARS-CoV-2 test 1.0 compared to real time RT-PCR (based on results of stage 2 of the study)Timepoint: 0 hours

Countries

India

Contacts

Public ContactOmshree Shetty

Tata Memorial Hospital

omshreens@gmail.com91-22-24177000

Outcome results

None listed

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