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Completed

NCT Number: NCT05281692

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

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

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UroPartners Urology Group

Chicago, Illinois, 60657, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Preservation Media (EPM-IX)

Diagnostic Test

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Convergent Genomics, Inc.

Network

Registry information

Official study title

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

Acronym: CGI-EPM-IX

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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