The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratorysettings in a home testing environment utilizing the clinical study design describedherein. The study will take place in simulated home environments which will be set upwithin or near active clinical settings (e.g., urgent care facilities). This will be aprospective study conducted at three or more investigational sites located within theUnited States for the clinical validation of the Metrix COVID Test for the detection ofSARS-CoV-2 AN swab samples. Additional sites may be added to the study in order to meetminimum subject/sample enrollment requirements and geographic prevalence of respiratoryvirus infections. Comparator testing will be performed to determine the infection statusof each sample for comparison to results generated by the candidate test. The primarycomparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2.
The Metrix COVID Test will be evaluated for OTC use in a home use 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 differential detection of SARS-CoV-2 in 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 detection of SARS-CoV-2.
The candidate device, Metrix COVID Test, will be evaluated with AN swab sample types.
Each Metrix COVID Test kit contains all supplies needed to test AN swab samples,
including a corresponding QRI for detailed instructions.
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.
For each participant, a comparator NP swab sample will be obtained by a healthcare
practitioner after testing with the candidate device. This NP swab will be tested with
the FDA-cleared SARS-CoV-2 assay according to the IFU and will serve as the primary
comparator for swab samples. An additional AN swab sample will be collected and stored
frozen and dry for later analysis to support future research validation studies.
No results from the investigational test or comparator testing will be used for clinical
diagnosis, management of study participants, or to make treatment decisions.
Test results from the Metrix COVID Test (investigational test) will be compared to the
test results generated from the comparator assay.
No investigational test results will be reported to a third party or used for any
treatment decisions.
This work is supported by funding provided by the Biomedical Advanced Research and
Development Authority (BARDA).
Diagnostic Test: Aptitude Medical Systems Metrix COVID Test
The Metrix COVID 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 via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2
gene targets will produce a positive SARS-CoV-2 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.
Inclusion Criteria:
1. Participant or guardian understands and is able and willing to provide written
informed consent, and assent where applicable, prior to study enrollment.
2. Male or female aged 2 years or older
3. 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.
4. 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.
5. 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:
1. Participant does not understand and/or is not able and willing to sign the study
informed consent and/or assent.
2. Participant or guardian is not able to comply with nasal swab collection
requirements following the QRI.
3. Participant has previously provided a sample for the study.
4. Participant is not able to tolerate sample collection.
5. Participant is currently undergoing antiviral treatment such as baloxavir marboxil
(trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir
(Rapivab®).
6. 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.
7. 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.
8. Participants who have had recent craniofacial injury or surgery, including to
correct deviation of the nasal septum, within the previous six (6) months.
9. Participants who do not understand/read the English language.
AFC Montclair
Birmingham, Alabama, United States
AFC Madison
Madison, Alabama, United States
PPU Mid City
Baton Rouge, Louisiana, United States
Brad Killingsworth, M.A.
281-467-4855
clinicaltrials@aptitudemedical.com
Not Provided