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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026370
Enrollment
2000
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

Sponsors

Capital Health Services India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1 1. Symptomatic group - confirmed RT-PCR testing, admitted and treated in isolation wards that are declared good-to-discharge by a RT-PCR retest or Clinician judgment. Group 2 1. Asymptomatic group from â??Positive-linkedâ?? like relatives or contactable connects of infected and tested positive. 2. Healthcare Workers / relatives of RT PCR positives Group 3 1. Asymptomatic group with no links or contractable connects of infected (Random) Group 4 1. Negative PCR 2. Co-morbidities risk such as Diabetes mellitus, hypertension and other chronic cardiac, liver, neurological and kidney ailments

Exclusion criteria

Exclusion criteria: 1. Symptomatic COVID-19 positive patients -within2 weeks of confirmatory RT-PCR 2. Symptomatic people with high fever, dry cough and respiratory distress

Design outcomes

Primary

MeasureTime frame
1. Evaluation of the consistency ofâ??Positive COVIDAB-SPâ?? for â??Positive PCRâ?? and Consistent â??Negative COVIDAB-SPâ?? for â??Negative PCRâ?? 2. Change in status of asymptomatic as a result of multiple testing involving antigens (RT PCR) and COVIDAB-SP for antibody detectionTimepoint: one time

Secondary

MeasureTime frame
1. Reliability of the marker for antibody detection 2. Contrasting results with positive and negative PCR 3. Reliability of COVIDAB for SurveillanceTimepoint: 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