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

QuantuMDx

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: RT-PCR Test; Diagnostic Test: Real-time PCR Test

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT05614011

QVTP-39

Details and patient eligibility

About

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

Full 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).

Enrollment: 877 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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877 participants in 1 patient group

Subjects 18+ years of age

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Real-time PCR Test

Diagnostic Test: RT-PCR Test