Trial Outcomes & Findings for SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings (NCT NCT06191393)

Results Overview

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, Flu A, and Flu B. Positive Percent Agreement (PPA) is the number of positive specimens identified by the candidate test divided by the total true positives per the comparator.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

614 participants

Primary outcome timeframe

45 minutes

Results posted on

2025-05-13

Participant Flow

Patients were recruited who displayed symptoms similar to COVID and Flu infections, themselves or a guardian could understand English, and were greater than the age of 2 years old.

N/A, all comers approach

Participant milestones

Participant milestones
Measure	OTC Study This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality. Aptitude Medical Systems Metrix COVID/Flu Test: The Metrix COVID/Flu Test is a real-time reverse transcription loop-mediated isothermal amplification reaction (RT-LAMP) test that has been designed to detect viral RNA from SARS-CoV-2, Influenza A, and Influenza B via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result, detection of the Flu A gene target will produce a positive Flu A result, and detection of the Flu B gene target will produce a positive Flu B result. If no target is detected and the internal control amplifies, the result is negative. If no amplification is detected in any of the channels, an invalid result is displayed.
Overall Study STARTED	614
Overall Study COMPLETED	556
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OTC Study n=556 Participants This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality.
Age, Categorical <=18 years	48 Participants n=556 Participants
Age, Categorical Between 18 and 65 years	473 Participants n=556 Participants
Age, Categorical >=65 years	35 Participants n=556 Participants
Sex: Female, Male Female	364 Participants n=556 Participants
Sex: Female, Male Male	192 Participants n=556 Participants
Self or Assisted Testers Self Tester	527 Participants n=556 Participants
Self or Assisted Testers Assisted Tester	29 Participants n=556 Participants

PRIMARY outcome

Timeframe: 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, Flu A, and Flu B. Positive Percent Agreement (PPA) is the number of positive specimens identified by the candidate test divided by the total true positives per the comparator.

Outcome measures

Outcome measures
Measure	OTC Study n=556 Participants This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality.
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 Assay PPA - SARS-CoV-2	95.5 PPA Interval 88.9 to 98.2
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 Assay PPA - Influenza A	95.8 PPA Interval 88.5 to 98.6
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 Assay PPA - Influenza B	95.2 PPA Interval 84.2 to 98.7

PRIMARY outcome

Timeframe: 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, Flu A, and Flu B. Negative Percent Agreement (NPA) is the number of negative specimens identified by the candidate test divided by the total true negatives per the comparator.

Outcome measures

Outcome measures
Measure	OTC Study n=556 Participants This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality.
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 Assay NPA - SARS-CoV-2	99.6 NPA Interval 98.5 to 99.9
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 Assay NPA - Influenza A	99.4 NPA Interval 98.2 to 99.8
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 Assay NPA - Influenza B	99.4 NPA Interval 98.3 to 99.8

Adverse Events

OTC Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brad Killingsworth

Aptitude Medical Systems, Inc

Phone: 2814674855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place