Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation

Last updated: January 30, 2024
Sponsor: QuantuMDx Group Ltd
Overall Status: Completed

Phase

N/A

Condition

Covid-19

Treatment

RT-PCR Test

Real-time PCR Test

Clinical Study ID

NCT05614011
QVTP-39
  • Ages > 18
  • All Genders

Study Summary

Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be over the age of 18 years.
  • Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5days of symptom onset.
  • Participants must have capacity to give informed consent.

Exclusion

Exclusion Criteria:

  • Participant is under the age of 18 years.
  • Participant does not have symptoms of SARS-CoV-2 infection.
  • Participant lacks capacity to give informed consent.

Study Design

Total Participants: 877
Treatment Group(s): 2
Primary Treatment: RT-PCR Test
Phase:
Study Start date:
November 28, 2022
Estimated Completion Date:
May 17, 2023

Study Description

The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.

The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).

Connect with a study center

  • Paragon Rx Clinical, Inc.

    Santa Ana, California 92703
    United States

    Site Not Available

  • Bright Research Center

    Miami, Florida 33144
    United States

    Site Not Available

  • EDP Biotech

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • PathAI

    Memphis, Tennessee 38125
    United States

    Site Not Available

  • PRX Research and Development, LLC DBA PRX Research

    Mesquite, Texas 75149
    United States

    Site Not Available

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