The Metrix COVID/Flu 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/Flu Test for thedifferential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or salivasamples. Additional sites may be added to the study in order to meet minimumsubject/sample enrollment requirements and geographic prevalence of respiratory virusinfections. One or more investigational sites outside of the US (at which participantsare required to be fluent in English) may also be included in the study depending onenrollment needs and geographical/seasonal prevalence of respiratory virus infections.Comparator testing will be performed to determine the infection status of each sample forcomparison to results generated by the candidate test. The primary comparator for thestudy will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.
The Metrix COVID/Flu 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/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 detection of SARS-CoV-2, Flu A,
and Flu B.
The candidate device, Metrix COVID/Flu Test, will be evaluated with two specimen types -
saliva and AN swab. Each Metrix COVID/Flu Test kit contains all supplies needed to test
either a saliva or AN swab sample, including a corresponding QRI for each specimen type.
It is possible for participants to elect to provide only a single sample type for the
study; however, both sample types should be collected when possible. If participants will
be testing both saliva and AN swab samples, the AN swab test should be conducted first.
If participants elect to provide only a single sample type, the AN swab will be
prioritized.
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, Flu A, and Flu B assay according to the IFU and will serve as
the primary comparator for both saliva and AN swab samples. An additional saliva sample
will also be obtained for SARS-CoV-2 analysis via a secondary comparator method, which
will be used for informational purposes only. 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/Flu 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/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.
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 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.
4. 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.
5. 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.
6. 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.
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 saliva or nasal swab collection
requirements following the QRI.
3. Participant has previously provided a sample for the study.
4. Participant has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past
5 days.
5. Participant is not able to tolerate sample collection.
6. Participant is currently undergoing antiviral treatment such as baloxavir marboxil
(trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir
(Rapivab®).
7. 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.
8. 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.
9. Participants who have had recent craniofacial injury or surgery, including to
correct deviation of the nasal septum, within the previous six (6) months.
10. Participants who do not understand/read the English language.
American Family Care
Trussville, Alabama, United States
Central Coast Laboratories
Goleta, California, United States
American Family Care
Chelmsford, Massachusetts, United States
Tyler Chozinski, PhD
8027349747
tyler.chozinski@aptitudemedical.com
Qin Yang, PhD
8027349747
qin.yang@aptitudemedical.com
Qin Yang, PhD, Principal Investigator
Aptitude Medical Systems