N/A
Completed N=877
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Source: ClinicalTrials.gov NCT05614011 ↗Enrolled (actual)
877
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test — 130 Participants
Summary
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test |
130 | — |
| PRIMARY Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test |
736 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05614011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.