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Evaluation of the performance of India Health Foundationâ??s (IHFâ??s) RT PCR kit for detection of COVID-19 virus (SARS-CoV-2) antigens

Clinical performance validation of India Health Foundationâ??s (IHFâ??s) RT PCR kit for detection of E gene, RdRP gene and Spike gene specific to COVID-19 virus (SARS-CoV-2) in the Naso Pharyngeal swab

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026499
Enrollment
1000
Registered
2020-07-10
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

Capital Health Services India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All NP samples that tested positive and negative in RT PCR assay will be made anonymous and included in the study before disposal

Exclusion criteria

Exclusion criteria: Left over sample is not adequate for the RT PCR assay

Design outcomes

Primary

MeasureTime frame
Sensitivity & Specificity of IHFâ??s RT PCR kit for COVID-19 Detection against any other standard RT-PCR based DetectionTimepoint: Baseline (one time)—

Secondary

MeasureTime frame
Validation of the independent use of IHFâ??s RT PCR kit for COVID-19 detectionTimepoint: One time—

Countries

India

Contacts

Public ContactDr R Arunkumar

Chettinad Hospital and Research Institute

arunrmbbs1978@gmail.com04447413322

Outcome results

None listed

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