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Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test

Aptitude Medical Systems · with Biomedical Advanced Research and Development Authority · NCT06744660

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
1000
US sites recruiting
3
Study start
October 17, 2024
Record last updated
October 2, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The Metrix COVID 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 Test for the detection of SARS-CoV-2 AN swab 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. 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.

Being studied: Aptitude Medical Systems Metrix COVID Test

Conditions: COVID-19; COVID

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 of respiratory tract infection (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 or guardian agrees to read, and is able to read with understanding, the AN swab QRI prior to beginning the operation of each of the Metrix COVID-19 Test.
  • Participant or guardian is able and willing to contribute the required swab samples for testing and understands and is able and willing to sign the study informed consent.

Exclusion Criteria

  • 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 nasal swab collection requirements following the QRI.
  • Participant has previously provided a sample for the study.
  • 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.

Recruiting US locations

  • AFC Montclair

    Birmingham, AL 35210

    Site contact: Brad Killingsworth · 2814674855 · clinicaltrials@aptitudemedical.com

  • AFC Madison

    Madison, AL 35758

    Site contact: Brad Killingsworth · 2814674855 · clinicaltrials@aptitudemedical.com

  • PPU Mid City

    Baton Rouge, LA 70802

    Site contact: Brad Killingsworth · 2814674855 · clinicaltrials@aptitudemedical.com

Study contacts (from the official record)

  • Brad Killingsworth, M.A. · 281-467-4855 · clinicaltrials@aptitudemedical.com
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Clinical Validation of the Aptitude Medical Systems Metrix… (NCT06744660) | Bored Studies