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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: RT-PCR Test; Diagnostic Test: Real-time PCR Test

• Registration Number: NCT05614011
• Lead Sponsor: QuantuMDx Group Ltd

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Study Start: 2022-11-28
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Results First Submitted: 2023-10-17
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 877

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects 18+ years of age	RT-PCR Test	A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.
Subjects 18+ years of age	Real-time PCR Test	A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test	One hour	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
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test	One hour	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.

Trial Locations

Locations (3)

Bright Research Center; 🇺🇸 Miami, Florida, United States

EDP Biotech; 🇺🇸 Knoxville, Tennessee, United States

PathAI; 🇺🇸 Memphis, Tennessee, United States