SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings

NCT06191393 | Completed Results FDA Device

• 1 other identifier: TP-23-003
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

SARS-CoV-2 Infection; Influenza A; Influenza B

Outcome Measures

Primary Outcomes (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

  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.

  45 minutes

• 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

  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.

  45 minutes

Study Arms (1)

OTC Study

EXPERIMENTAL

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.

Diagnostic Test: Aptitude Medical Systems Metrix COVID/Flu Test

Interventions

Aptitude Medical Systems Metrix COVID/Flu Test DIAGNOSTIC_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.

OTC Study

Eligibility Criteria

• Age: 2 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.
• Male or female aged 2 years or older
• Participant is currently exhibiting fever, or one or more symptoms associated with COVID-19 and/or influenza (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea). Participant must still be exhibiting symptoms on the day of sample collection.
• Participant has not eaten, consumed a beverage, smoked, brushed their teeth, gargled with mouth wash, or chewed gum for 30 minutes prior to collecting a saliva sample.
• Participant or guardian agrees to read, and is able to read with understanding, each of the saliva and/or AN swab QRI prior to beginning the operation of each of the Metrix COVID/Flu Test.
• Participant or guardian is able and willing to contribute the required saliva and/or swab samples for testing and understands and is able and willing to sign the study informed consent.

You may not qualify if:

• Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent.
• Participant or guardian is not able to comply with saliva or nasal swab collection requirements following the QRI.
• Participant has previously provided a sample for the study.
• Participant has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
• Participant is not able to tolerate sample collection.
• Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
• Participants currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
• Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
• Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
• Participants who do not understand/read the English language.

Sponsors & Collaborators

• Aptitude Medical Systems: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (3)

American Family Care

Trussville, Alabama, 35235, United States

Location

Central Coast Laboratories

Goleta, California, 93117, United States

Location

American Family Care

Chelmsford, Massachusetts, 01824, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Brad Killingsworth
• Organization: Aptitude Medical Systems, Inc

brad.killingsworth@aptitudemedical.com

2814674855

Study Officials

• Qin Yang, PhD

  Aptitude Medical Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Some participants will know their SOC diagnosis before completing testing on our device.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: January 5, 2024
• Study Start: November 20, 2023
• Primary Completion: March 3, 2024
• Study Completion: March 11, 2025
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)