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

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

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

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).

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.