N/A N=877 Diagnostic

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

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT05614011 ↗

Enrolled (actual)

877

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test — 130 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RT-PCR Test (Diagnostic_test); Real-time PCR Test (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: QuantuMDx Group Ltd
Primary completion: May 2023

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	—

Summary

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

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.

View full record on ClinicalTrials.gov →

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.