Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )

SARS-CoV-2 Clinical Trial

— CGI-EPM-IX  

Official title:

Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281692
• Other study ID #: CGI-EPM-IX
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: March 21, 2022

Study information

• Verified date: October 2022
• Source: Convergent Genomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)

Description:

This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be =18 years of age

• Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit

• Subject must be able to understand and willingly provide informed consent

Exclusion Criteria:

• Cannot provide informed consent

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Diagnostic Test:
• Enhanced Preservation Media (EPM-IX)
EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance.

Locations

Country	Name	City	State
United States	UroPartners Urology Group	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Convergent Genomics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Diagnostic Performance	Comparison of diagnostic performances (sensitivity, specificity, and predictive values) of EPM-IX vs Med Schenker's STM viral media with detection of SARS-CoV-2 infection.	At the time of inclusion
Secondary	Comparison of Lab Processing	Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media	At the time of inclusion
Secondary	Quantitative PCR CT-values	Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media	At the time of inclusion
Secondary	Difference in case rate or detection of viral load samples observed	Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media	At the time of inclusion