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

C

Convergent Genomics

Status

Completed

Conditions

SARS-CoV-2

Treatments

Diagnostic Test: Enhanced Preservation Media (EPM-IX)

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05281692
CGI-EPM-IX

Details and patient eligibility

About

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

Full 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.

Enrollment

205 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

205 participants in 2 patient groups

Positive
Description:
Enhanced Preservation Media (EPM-IX)
Treatment:
Diagnostic Test: Enhanced Preservation Media (EPM-IX)
Control
Description:
Med Schenker's STM viral media
Treatment:
Diagnostic Test: Enhanced Preservation Media (EPM-IX)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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