Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
Phase: NA
Conditions: SARS-CoV-2 Infection, Influenza A, Influenza B
Sponsor: Aptitude Medical Systems

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 1 of 6 
 
 
Protocol Title: 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for 
Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory 
Settings  
 
Protocol ID: 
TP-23-003 
NCT06191393 
 
Version 
0 
 
Date: 
23 OCT 2023 
 
Sponsor: 
Aptitude Medical Systems, Inc. 
125 Cremona Drive, Ste. 100 
Goleta, CA 93117 
 
Sponsor Contact: 
Tyler Chozinski, PhD 
Aptitude Medical Systems, Inc. 
Head of Scientific and Medical Affairs 
tyler.chozinski@aptitudemedical.com 
125 Cremona Drive, Ste. 100 
Goleta, CA 93117 
 
 
 
 
CONFIDENTIALITY NOTICE: 
The information contained in this document is proprietary and confidential. Any distribution, copying, or 
disclosure is strictly prohibited unless such disclosure is required by federal regulations or state law.  Persons to 
whom the information is disclosed must know that it is confidential and that it may not be further disclosed by 
them. 
 
 
The Metrix COVID/Flu Test is intended for 510(k)/De Novo submission.  
FOR INVESTIGATIONAL USE ONLY and has not been FDA cleared/market authorized  
The performance characteristics of this product have not been established. 
 
 
 
 
 
 
 
 
 

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 2 of 6 
 
 
 
 
1. Protocol Summary 
Protocol Title 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test 
for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and At-
Home/Non-Laboratory Settings 
Investigational Device(s) 
Metrix COVID/Flu Test  
Metrix Reader (Gen 2) 
Primary Objective(s) 
To evaluate the clinical performance (Positive Percent Agreement, 
Negative Percent Agreement, and 95% confidence intervals) of the Metrix 
COVID/Flu Test in detecting SARS-CoV-2, Influenza A, and Influenza B 
compared to an FDA-cleared comparator assay. 
Primary Endpoint(s) 
For each target: 
• 
PPA ≥95% (lower bound 95% CI ≥85%)  
• 
NPA ≥98% (lower bound 95% CI ≥95%) 
Study Design and Procedures 
This is a multi-site, prospective, cross-sectional study. Enrollment will 
occur in an “all-comers”/sequential manner after written informed 
consent (and/or verbal assent, in the case of minors) and confirmation of 
eligibility.  
 
All standard-of-care specimens will be collected prior to any study 
specimens. Participants will be asked to complete a self-test (or assisted 
for those under 14 years) using the investigational devices. Participants 
will execute all steps necessary to complete the test, including result 
interpretation, without any guidance or aid from study coordinators.  
 
After testing with the investigational devices, a healthcare professional 
will collect a nasopharyngeal swab specimen for comparator assay 
analysis by an external reference laboratory. Comparator results will not 
be provided to participants.  
 
Results from the investigational device will not be used to make patient 
healthcare decisions. Healthcare management will be determined by the 
healthcare provider and their patient without any involvement of the 
Sponsor.  
Study Population 
Individuals aged 2+ years with signs and symptoms of respiratory 
infection. Intended users of the investigational device include lay-users 
(OTC/home use) with no prior laboratory experience with the 
investigational device. Participants aged 14 years and up will perform 
self-testing and participants below 14 years will be assisted by an adult. 

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 3 of 6 
 
Number of Participants 
Enrollment and testing will continue until a minimum of 500 negative 
specimens, 50 positive SARS-CoV-2 specimens, 50 positive Flu A 
specimens, and 30 positive Flu B specimens are collected.  
Inclusion/Exclusion Criteria 
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 specimen 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/Flu Test.  
5. Participant or guardian is able and willing to contribute the required 
swab specimens 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 specimen for the study. 
4. Participant is not able to tolerate specimen collection. 
5. Participant is currently undergoing antiviral treatment such as 
baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), 
zanamivir (Relenza®), and peramivir (Rapivab®). 
6. Participant is currently underoing, and/or has undergone within the 
past 30 days, treatment 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 
specimen collection. 
Study Sites 
The study will be conducted at a minimum of three investigational 
sites located within the United States. Additional sites may be added 
to the study to meet minimum subject/specimen enrollment 
requirements and geographic prevalence of respiratory virus 

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 4 of 6 
 
infections. This may include utilizing one or more investigational sites 
outside of the US (at which participants are required to be fluent in 
English), depending on enrollment needs and geographical/seasonal 
prevalence of respiratory virus infections.  
 
This study will be conducted in simulated home environments set up 
within or near clinical settings (e.g., urgent care clinics).  
Study Duration 
The study is to take place during the 2023 respiratory season. The 
estimated length of the specimen collection and testing phase is expected 
to be up to 24 weeks with an additional 2 to 3 weeks of study preparation 
and 2 weeks of final study closeout. Therefore, the total estimated study 
duration is up to 29 weeks. If the prevalence for any of the candidate 
analytes is low (such that enrollment targets are not met), the study may 
be extended into the next respiratory season to facilitate collection of 
additional specimens.  
 
2. Reference Documents 
1. Premarket Validation Recommendations for Developers of SARS-CoV-2 Molecular Single Analyte In Vitro 
Diagnostic Tests and Multi-Analyte Molecular Respiratory Panels that Include SARS-CoV-2 (Feb 2021) 
 
3. Statistcal Analysis 
 
3.1. Clinical Performance Analysis 
For each target, the following analysis will be performed to obtain a measure of clinical performance of 
the Metrix COVID/Flu Test versus the FDA-cleared comparator assay. Positive Percent Agreement (PPA) 
and Negative Percent Agreement (NPA) will be calculated as shown below. The PPA and NPA will be 
presented in separate 2x2 tables for each target with comparator vs investigational test (test device). 
 
 
Comparator Test 
Positive 
Negative 
Test 
Device 
Positive 
A 
B 
Negative 
C 
D 
 
Positive percent agreement = 100% x A/(A+C)  
Negative percent agreement = 100% x D/(B+D) 
 
The two-sided 95% Confidence Interval (CI) will be calculated using the Wilson Score method. 
 
The study will also report participant demographics, percentage of invalid test results and 
investigational test performance on days from symptom onset (if applicable). 
3.2. Clinical Validation Acceptance Criteria 
The study results will be reported in 2×2 tables to calculate the estimated positive and negative percent 
agreements with the comparison device/method. Wilson two-sided 95% confidence intervals will also 

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 5 of 6 
 
be constructed for the positive percent agreement and negative percent agreement statistics. The 
study will also report participant demographics and invalid test results. Success criteria are defined as a 
PPA ≥95% (lower bound 95% CI ≥85%) and an NPA ≥98% (lower bound 95% CI ≥95%). 
 
4. Good Clinical Practices (GCP), Ethical Considerations, and Administrative Issues 
 
4.1. Study Oversight 
Each enrollment site may be subject to monitoring or auditing to ensure that study procedures are 
being appropriately followed and records have been maintained according to requirements. Data 
collected during the study must be provided to the Study Monitor on a regular basis (at least monthly 
or at the discretion of the Sponsor) and will be reviewed for accuracy and consistency. At the discretion 
of the Sponsor, this protocol may be prematurely terminated. Reasons may include, but are not limited 
to, meeting enrollment minimum requirements and acceptance criteria, new regulatory pathway 
information, business and/or market information/changes. 
 
4.2. Institutional Review Board (IRB) Approval 
This protocol will be reviewed by an approved central or local institutional review board (IRB) prior to 
the start of the study. A copy of the IRB approval(s) will be maintained by the study Sponsor and each 
participating study site Principal Investigator prior to and during the study. 
 
4.3. Informed Consent and Withdrawal 
Participant participation is voluntary. Participants must provide written consent (and verbal assent, in 
the case of minors) as part of the informed consent process. The Investigator will ensure that each 
study participant, or thier legally acceptable representative, is fully informed about the nature and 
objectives of the study and possible risks of participation prior to signing the ICF. Consent may be 
obtained electronically in accordance with local requirements. The Investigator will retain the original 
of each signed ICF.  
 
Participants may be withdrawn from the study by any of the following mechanisms: 
● Voluntary withdrawal by the participant at any time. 
● Determination by the Investigator that withdrawal is in the best interest of the participant. 
● Determination by the Sponsor that withdrawal is in the best interest of the participant or study. 
● Determination after review that the participant was not eligible for the study. 
 
All data collected from enrollment until withdrawal will be retained and used. Data may be collected 
from participants who voluntarily withdraw before completing specimen collection. All specimens will 
be collected, retained, and used unless the participant withdraws or is withdrawn for any reason. 
Participants who withdraw or are withdrawn may be replaced. 
 
4.4. Confidentiality and Specimen/Data De-Identification 
The identity of study participants and collected information will remain confidential. All study 
participants and associated specimens including demographic and test result information will be 

 
 
Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-
CoV-2 and Influenza A/B in Point-of-Care and At-Home/Non-Laboratory Settings  
Protocol Version: 0 
Protocol ID: TP-23-003 
 
Aptitude Medical Systems, Inc. 
CONFIDENTIAL 
Page 6 of 6 
 
identified by a Study Participant ID code. All participant confidential identifiers will be removed from 
study specimens and the integrity of all protected health information (PHI) will be maintained in 
accordance with the IRB approved informed consent form. Only coded test results with minimal clinical 
information will be provided to the Sponsor. Investigational results (candidate assay) will not be made 
part of the participant’s medical record. 
 
4.5. Participant Risks and Benefits 
Collection of upper respiratory swab specimens represents minimal risk to each participant but may 
cause some discomfort and/or minor bleeding. 
 
There are no personal benefits to the study participants for participation in the study other than the 
knowledge gained by the Sponsor to help develop a new diagnostic test. 
 
4.6. Protocol Deviations 
The protocol described for this study will only be changed or altered on the express written approval of 
the PI, Study Manager, Sponsor, and IRB (when applicable). 
 
4.7. Safety 
 
4.7.1. Adverse Event (AE) 
An adverse event is any unanticipated medical occurrence, unintended disease or injury or 
any untoward clinical signs (including any abnormal medical finding) in participants, users, or 
other persons whether or not related to the investigational medical device. 
 
4.7.2. Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event.  
 
4.7.3. Unanticipated Serious Adverse Device Effect (USADE) 
Unanticipated adverse device effect is any serious adverse effect on health or safety, any life-
threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the application; 
or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of participants or users of the investigational medical device. 
 
A serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report.  
 
4.7.4. Adverse Event Reporting Requirements 
The Investigator will report all Serious Adverse Events to the Sponsor within 24 hours of discovery 
and must be followed by a report within 10 days. Reports can be sent via email to the sponsor 
contact listed at the start of this protocol. The AE must also be reported to the Investigator’s IRB.