Status:
UNKNOWN
Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus
Lead Sponsor:
Bangladesh Medical Research Council (BMRC)
Conditions:
High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit
Eligibility:
All Genders
5-65 years
Brief Summary
The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,91...
Detailed Description
Considering the current global pandemic, just like any other countries it is becoming very difficult for Bangladesh to fight the COVID-19 spread. An increased number of testing is needed in Bangladesh...
Eligibility Criteria
Inclusion
- Samples with positive RT-PCR results with Ct value ≤30 for the COVID-19 gene(s) at IEDCR will be selected as COVID-19 positive.
- Samples with negative RT-PCR results with no amplification for the COVID-19 gene(s) at IEDCR will be selected as COVID-19 negative.
Exclusion
- Samples with equivocal/ambiguous RT-PCR results in terms of sigmoidal curve and Ct value will be excluded.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 24 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04403672
Start Date
May 18 2020
End Date
July 24 2020
Last Update
May 28 2020
Active Locations (1)
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1
Institute of Epidemiology, Disease Control and Research (IEDCR), Mohakhali, Dhaka (For sample collection & sample storage), Institute for Developing Science & Health Initiatives (ideSHi); Mohakhali, Dhaka (For sample analysis, data collection, data analys
Dhaka, Bangladesh