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Evaluation of the performance of rapid diagnostic kit (COVIDAG-SP) in the detection of COVID-19 virus antigen

Clinical performance validation of Recombinant Immunogenic Marker (India Health Foundation-IHFs COVIDAG-SP) based on single-chain fragment variable (scFv) specific to Spike S I & S II variable regions of SARS CoV2 for rapid detection of Antigen

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026369
Enrollment
500
Registered
2020-07-05
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: Not Applicable as the study is for validation of diagnostic kit performance Control Intervention1: NIL: Not Applicable as the study is for validation of diagnostic kit performance

Sponsors

Capital Health Services India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 Years and above 2. Both males and females 3. Confirmed COVID-19 positive through RT-PCR in less than 24 hours of confirmation or Symptomatic and seeking RT-PCR testing to learn their COVID-19 status

Exclusion criteria

Exclusion criteria: 1. Cross reactive viral positive for HIV, HbsAg, NL-63, CoV1 (If suspected, they will be excluded and no serological evaluation will be applied to know the status) 2. Severe co-morbidities compromising the study participation 3. COVID-19 positive currently under observation/treatment after 24hrs of RT-PCR confirmatory test.

Design outcomes

Primary

MeasureTime frame
Sensitivity and Specificity of IHFs COVIDAG-SP for COVID-19 Antigen Detection against RT-PCR based DetectionTimepoint: One time—

Secondary

MeasureTime frame
1. Evaluation of Naso Pharyngeal swab, Saliva and Serum sample sensitivity and specificity for the recombinant scFv antigenic marker 2. Validation of the independent use of COVIDAG-SP for COVID-19 Antigen detectionTimepoint: One time—

Countries

India

Contacts

Public ContactDr R Arunkumar

Chettinad Hospital and Research Institute

arunrmbbs1978@gmail.com9884212644

Outcome results

None listed

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