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

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ClinicalTrials.gov Identifier: NCT05281692
Recruitment Status : Completed
First Posted : March 16, 2022
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
Convergent Genomics, Inc.

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

Condition or disease Intervention/treatment
SARS-CoV-2 Diagnostic Test: Enhanced Preservation Media (EPM-IX)

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
Actual Study Start Date : February 2, 2022
Actual Primary Completion Date : March 21, 2022
Actual Study Completion Date : March 21, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Positive
Enhanced Preservation Media (EPM-IX)
 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.
Control
Med Schenker's STM viral media
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Diagnostic Performance [ Time Frame: At the time of inclusion ]
    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.


Secondary Outcome Measures :
  1. Comparison of Lab Processing [ Time Frame: At the time of inclusion ]
    Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media

  2. Quantitative PCR CT-values [ Time Frame: At the time of inclusion ]
    Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media

  3. Difference in case rate or detection of viral load samples observed [ Time Frame: At the time of inclusion ]
    Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects ≥ 18 years of age who are being tested for COVID-19
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05281692


Locations
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United States, Illinois
UroPartners Urology Group
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Convergent Genomics, Inc.
Investigators
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Principal Investigator: Paul Yonover, MD UroPartners, LLC
More Information
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Responsible Party: Convergent Genomics, Inc.
ClinicalTrials.gov Identifier: NCT05281692    
Other Study ID Numbers: CGI-EPM-IX
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Convergent Genomics, Inc.:
EPM-IX
Covid-19
SARS-CoV-2
Nasopharyngeal swab
Med Schenker's STM viral media