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

COVID-19 Clinical Trial

Official title:

Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614011
• Other study ID #: QVTP-39
• Status: Completed
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: January 2024
• Source: QuantuMDx Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be over the age of 18 years.

• Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.

• Participants must have capacity to give informed consent.

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• RT-PCR Test
High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril.
• Real-time PCR Test
Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample.

Locations

Country	Name	City	State
United States	EDP Biotech	Knoxville	Tennessee
United States	PathAI	Memphis	Tennessee
United States	Bright Research Center	Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
QuantuMDx Group Ltd	Bright Research Center, New Day Diagnostics, PathAI

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test	The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results	One hour
Primary	Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test	The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.	One hour