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Rapid diagnostic test for the detection of COVID-19 antibodies

Validation of a rapid diagnostic test for the detection of COVID-19 antibodies

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026469
Enrollment
100
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

HealthCubed India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Negative SARS-CoV-2 subjects: Aged 18 years of age or over Negative SARS-CoV-2 result by RT-PCR Positive SARS-CoV-2 subjects: Aged 18 years of age or over Positive SARS-CoV-2 result by RT-PCR Requires hospitalisation 10 days post onset of symptoms

Exclusion criteria

Exclusion criteria: Negative SARS-CoV-2: • Aged less than 18 years • Outpatients • History of known immune suppression • Participation in any other trial Positive SARS-CoV-2: • Aged less than 18 years • Patients unlikely to survive >28 days in view of attending medical team • Outpatients • Anticipated transfer to another hospital within 72 hours • History of known immune suppression • Less than 10 days since the onset of symptoms • Participation in any other trial

Design outcomes

Primary

MeasureTime frame
1.No lines - invalid Test 2.Control line Visible - Negative 3.Control lINE and IgM or IgG and IgG lines visible - PositiveTimepoint: 13 weeks

Secondary

MeasureTime frame
Sensitivity and SpecificityTimepoint: 13 weeks

Countries

India

Contacts

Public ContactDr Monila Patel

Department of Medicine

monilapatel@hotmail.com

Outcome results

None listed

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