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Observational Study of Sensitivity and Specificity of COVID-19 Screening and Diagnostics in COVID-19 Infected Individuals.

Development of an Isothermal PCR assay as an apt screening tool for Covid-19 (Bionest incubatee)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026451
Enrollment
150
Registered
2020-07-09
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: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

InnoDx Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All patients whose RT-PCR for COVID-19 is positive with high load (with good amplification curve and Ct value range from 10 to 25), will be included in this study as COVID cases. 2) All patients whose RT-PCR for COVID-19 is negative (Ct value is undetermined), will be included in this study as COVID negative cases.

Exclusion criteria

Exclusion criteria: 1) All the patients whose RT-PCR result is inconclusive (amplification curve not seen but giving Ct value) will not be included in this study.

Design outcomes

Primary

MeasureTime frame
Development cost-effective COVID-LAMP assay kitTimepoint: 7 months—

Secondary

MeasureTime frame
Sensitivity and specificity of COVID-LAMP kitTimepoint: 7 months—

Countries

India

Contacts

Public ContactDr Sandeep Verma

InnoDx Solutions Pvt Ltd

sci.m@inno-dx.com

Outcome results

None listed

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