2 and older, any sex, with SARS-CoV-2 Infection or Influenza A. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Positive Percent Agreement Performance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator AssayPrimary· 45 minutes
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2,
PPA - SARS-CoV-2
Group
Value
95% CI
OTC Study
95.5
88.9 – 98.2
PPA - Influenza A
Group
Value
95% CI
OTC Study
95.8
88.5 – 98.6
PPA - Influenza B
Group
Value
95% CI
OTC Study
95.2
84.2 – 98.7
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Negative Percent AgreementPerformance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator AssayPrimary· 45 minutes
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2,
NPA - SARS-CoV-2
Group
Value
95% CI
OTC Study
99.6
98.5 – 99.9
NPA - Influenza A
Group
Value
95% CI
OTC Study
99.4
98.2 – 99.8
NPA - Influenza B
Group
Value
95% CI
OTC Study
99.4
98.3 – 99.8
Sponsor's own description
The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other Aptitude Medical Systems trials
Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aptitude Medical Systems
Last refreshed: 13 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06191393.