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Comparative Evaluation of alternative kits required for RTPCR testing in diagnosis of COVID-19 illness

Clinical validation of 1) VereRT™ COVID-19 PCR Kit and VereRT™ Duo COVID-19 PCR Kit using RNA extracted from SARS-CoV-2 in nasopharyngeal swab collected from both left and right nostrils as specimen type in VTM; 2) VereRT™ ZeroPrep™ COVID-19 PCR Kit testing two sample matrices: direct testing from nasopharyngeal swab collected from both left and right nostrils in VTM as specimen type, and direct testing from human saliva (collected by using ZeroPrep™ Saliva Collection Kit); 3) VereRT™ ZeroPrep™ Duo COVID-19 PCR Kit direct testing from human saliva (collected by using ZeroPrep™ Saliva Collection Kit) - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037460
Enrollment
900
Registered
2021-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

None listed

Sponsors

Veredus Laboratories Pte Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria For COVID-19 Positive Patients 1.Patients with 18 years age or older of either gender with confirmed RT-PCR positive result for COVID-19 illness. 2.Close contacts of known COVID positive case with 18 years age or older of either gender found RT-PCR positive result for COVID-19 illness. 3.Confirmed hospitalized patients for COVID-19 illness with 18 years age or older of either gender. 4.Home quarantined patients with confirmed RT-PCR positive result for COVID-19 illness with 18 years age or older of either gender. 5.Individuals with 18 years age or older of either gender undergoing RT-PCR testing for COVID-19 illness for any other reason and found positive. Inclusion Criteria For COVID-19 Negative Subjects 1.Apparently healthy and asymptomatic subjects with 18 years age or older of either gender. 2.Close contacts of known COVID positive case with 18 years age or older of either gender undergoing COVID RT-PCR testing and found negative. 3.Individuals 18 years age or older of either gender undergoing RT-PCR testing for COVID-19 illness for any other reason and found negative.

Exclusion criteria

Exclusion criteria: Exclusion Criteria For COVID-19 Positive and negative participants 1.Patients where it is impossible/unsafe to obtain the required research samples. 2.Vulnerable population (critically ill, children, prisoners, etc). 3.Patients who deny to sign written informed consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
1. To estimate sensitivity of new COVID-19 illness diagnostic kits 2. To estimate specificity of new COVID-19 illness diagnostic kitsTimepoint: One time assessment will be done within 5 days of biological sample collection—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactVinay Onkar

ACCUTEST RESEARCH LABORATORIES (I) PVT LTD

prashant.basapure@accutestglobal.com02227780718

Outcome results

None listed

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