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

Study Overview
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Brief Summary
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Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

Detailed Description
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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).

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

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: RT-PCR Test
* Diagnostic Test: Real-time PCR Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects 18+ years of age<br>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. | Diagnostic Test: RT-PCR Test<br>* 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.<br>Diagnostic Test: Real-time PCR Test<br>* 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.<br>* Other names: Q-POC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement | 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 | 3 months | 
| Negative Percent Agreement | 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. | 3 months |