Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
Phase: NA
Conditions: COVID-19
Sponsor: QuantuMDx Group Ltd

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CONTROLLED DOCUMENT – DO NOT PRINT OR PHOTOCOPY WITHOUT AUTHORISATION 
IF PRINTED DESTROY IMMEDIATELY FOLLOWING USE 
 
Q-POC SARS-CoV-2 Assay (Q27001) 
Clinical Performance Study Plan 
 
 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
 
 
 
1 Scope 
This document details the testing plan to determine the clinical performance of the Q-POC 
SARS-CoV-2 Assay (Q27001) in accordance with FDA requirements. 
 

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2 Referenced Documents 
Document ID 
Title 
QQA-8 
Document Control Procedure 
QTEM-270 
Deviation Record Template Form  
QQA-14 
Control of non-conforming product 
 
3 Device Intended Use 
The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument 
for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome 
Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals 
suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified 
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that 
meet requirements to perform high complexity or moderate complexity tests.  
Results are for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in 
nasal mid-turbinate swabs (MTSW) during the acute phase of infection. Positive results are 
indicative of the presence of SARS-CoV-2 and aids in the diagnosis of COVID-19 if used in 
conjunction with other clinical and epidemiological information. Positive results do not rule out 
bacterial infection or co-infection with other viruses.  
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis 
for patient management decisions. Negative results must be combined with clinical 
observations, patient history, recent exposures and epidemiological information. Laboratories 
within the United States and its territories are required to report all results to the appropriate 
public health authorities. 
The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received 
specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC 
instrument (Q29001).  
4 Sponsor 
Sponsor Name 
 
QuantuMDx Group Ltd 

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Sponsor Address 
Lugano Building, 57 Melbourne Street, 
Newcastle upon Tyne, 
NE1 2JQ, 
United Kingdom 
 
 
5 Clinical Research Organisation 
Sponsor Name 
 
EDP Biotech 
Sponsor Address 
6701 Baum Drive 
Suite 110 
Knoxville, TN 37919 
 
6 Principle Investigator and Study Site(s) 
Principle 
Investigator 
Name 
Jason Liggett, PhD. 
Principle 
Investigator 
Address 
6701 Baum Drive 
Suite 110 
Knoxville, TN 37919 
Principle 
Investigator 
Professional Position 
Lead Scientist 
Name and Address of 
Study Site(s) 
Poplar Healthcare 
3495 Hacks Cross Road 
Memphis, Tennessee 38125 
 
Paragon Rx Clinical, Inc. 

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1002 N. Fairview Street 
Santa Ana, CA 92703 
 
PRX Research 
1011 N. Galloway Avenue 
Mesquite, TX, 75149 
 
7 Study Synopsis 
Title 
Q-POC SARS-CoV-2 Assay Clinical Performance Study Plan 
Primary Objective 
To evaluate the clinical diagnostic performance (positive percent 
agreement [PPA] and negative percent agreement [NPA]) of 
QuantuMDx’s Q-POC SARS-CoV-2 Assay when running mid-turbinate 
nasal swab (MTSW; also known as nasal mid-turbinate, NMT) compared 
to Roche Cobas 6800 SARS-CoV-2 Comparator Test.  
Study Design 
Prospective clinical study enrolling patients with signs and symptoms 
that are consistent with SARS-CoV-2. Positive and negative specimens 
will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-
approved reference standard. The reference standard will be the Roche 
Cobas 6800 SARS-CoV-2. 
Three clinical testing sites, located in different geographical locations 
of the U.S., will be used to collect SARS-CoV-2 positive and negative 
specimens. Testing sites may be independent from sample collection 
sites – i.e., there can be multiple sample specimen collection sites that 
feed into the three testing sites. 
Study Population 
Prospectively enrolled patients >18 years of age with signs and 
symptoms that are indicative of SARS-CoV-2 infection. 
Subject populations must be from the U.S. to be representative of the 
intended patient population(s).  
 

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Intended Sample 
Type 
Nasal mid-turbinate swab specimens (MTSW) 
Sample Size 
Nasal mid-turbinate swab (MTSW) swab samples from sufficient 
participants to achieve a minimum target at the end of the study of: 
50 comparator test-confirmed SARS-CoV-2 positive samples  
500 comparator test-confirmed SARS-CoV-2 negative samples. 
Eligibility Criteria 
Inclusion Criteria 
Participants must: 
Be over the age of 18 years. 
Present with symptoms indicative of SARS-CoV-2 infection, within 0-5 
days of symptom onset. 
Have capacity to give informed consent. 
Exclusion Criteria 
Under the age of 18. 
No symptoms of SARS-CoV-2 infection. 
Lack of capacity to give informed consent. 
 
Study Duration 
The study period will start on 07NOV22 and will continue until sample 
collection is complete. 
Study Personnel 
The study should include 1-3 operators at each of 3 sites to run Q-POC 
tests. 
Trained professionals at clinical diagnostic testing sites will collect the 
specimens and run the comparator test. 
 
8 Objectives of the Clinical Performance Study  
To evaluate the clinical diagnostic performance (PPA and NPA) of QuantuMDx’s Q-POC SARS-
CoV-2 Assay when compared to the Roche Cobas 6800 SARS-CoV-2 in compliance with FDA 
requirements. 

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9 IVD Medical Device Under Investigation and Comparator(s) 
Table 1: Information on the IVD Medical Device Under Investigation 
Device Under Test 
Manufacturer 
Product 
Number 
Q-POC 
QuantuMDx Group Ltd 
Q29001 
Q-POC 
SARS-CoV-2 
Assay 
QuantuMDx Group Ltd 
Q27001 
 
Table 2: Information on the comparator assay 
Comparator Device 
Manufacturer 
Product Number 
Roche cobas SARS-
CoV-2 (Assay for 
6800) 
Roche 
SARS-CoV-2-192T 
P/N: 
09175431190, 
cobas®  
SARS-CoV-2-480T P/N: 09343733190  
 
cobas® SARS-CoV-2 
Control Kit  
Roche 
P/N: 09175440190 
cobas® 6800/8800 
Buffer 
Negative 
Control Kit  
Roche 
P/N: 07002238190 
Roche cobas 6800 
system 
 
Roche 
P/N: 05524245001 
10 Testing Sites 
The study will be conducted at three external collection and testing sites located in the U.S. (in 
different geographical locations).  
Testing sites may be independent from sample collection sites – i.e., there can be multiple 
sample collection sites that feed into the three testing sites. If some non-U.S. testing/collection 
sites are chosen, the relevance of this patient population to a U.S. population will be 
documented. 
11 Operators 
The study will include 1-3 operators at each site and at least nine (9) operators across all sites. 
The operator study participants enrolled must represent anticipated operators of the Q-POC 
SARS-CoV-2 Assay within the use-case environment. They should be laboratory personnel who 

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have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with 
the Q-POC instrument (Q29001). Operators must be suitably trained to work in laboratories 
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 
§263a, that meet requirements to perform high complexity or moderate complexity tests. 
Operators should be personnel currently employed in the selected intended use sites and 
testing should be integrated into the daily workflow of the facility. 
Education (including experience and training) and the occupation of each operator will be 
recorded and tabulated for each operator enrolled in the study. Study sites will be required to 
provide CVs and a filled in information form for potential operators prior to approval for their 
inclusion in the study. This will ensure that the participants meet the definition of intended 
operators. 
The operators who participate in the study will be provided with the test kit in the form that 
will be made available in the actual intended use settings when the test is marketed. The 
operators should also be provided with the instructions for use and the training that is intended 
for such operators.  
12 Specimen Information 
12.1 Specimen Type to be Tested 
Table 3: Claimed specimen type to be validated in this Clinical Performance Study Plan (QVTP-39) 
Anatomical 
Location/Sample type 
Common/Uncommon 
Respiratory Sample 
Type 
Diluted 
into 
Liquid? 
Type of Liquid/Transport 
medium 
Mid-turbinate 
nasal 
swab (MTSW) 
Common 
Yes 
MSwab 
preservation 
medium 
 
The comparator test, Roche Cobas 6800 SARS-CoV-2 Test is validated for testing 
nasopharyngeal swab samples (NPS); therefore, an additional set of this specimen type will be  
collected for the comparator test in Copan UTM. 
Sample Categories: 
• 
Category I: Fresh samples, prospectively collected and tested in an ‘all comers’ 
fashion. 
• 
Category II: Archived samples prospectively collected, frozen, and retrospectively 
tested. All samples are collected and tested in an ‘all comers’ fashion. 

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Ideally, Category II samples should be limited to no more than 30% of the total prospective 
samples enrolled in the clinical study. 
Please note that Category I and II samples must be collected sequentially from all patients 
meeting study inclusion criteria and representing the assay’s intended use population (i.e., not 
pre-selected) presenting at a clinical facility between two pre-determined dates. This minimizes 
bias and prevalence of infection in the population can be evaluated. The Category II samples 
should be appropriately stored (e.g., frozen at -70˚C to -80˚C). 
It is anticipated that within this clinical study both the comparator and candidate samples will 
be tested under the Category I conditions.  
12.2 Method of Specimen Collection 
 

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12.3 Inclusion and Exclusion Criteria 
Inclusion Criteria: 
Participants must: 
• 
Be over the age of 18 years. 
• 
Present with any symptoms indicative of SARS-CoV-2 infection within 0 to 5 days of 
symptom onset. 

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• 
Have capacity to give informed consent. 
Exclusion Criteria: 
Participants must not: 
• 
Be under the age of 18. 
• 
Have no symptoms indicative of SARS-CoV-2 infection. 
• 
Lack capacity to give informed consent. 
Required patient and sample data to be recorded: 
• 
Collection testing date and time 
• 
Age 
• 
Sex 
• 
Country of residence 
• 
Ethnicity 
• 
Clinical signs and symptoms 
• 
Time since onset of symptoms 
• 
Clinical history 
• 
Co-morbidities 
• 
Medications taken or administered 
• 
Vaccination status (SARS-CoV-2 and Influenza) 
• 
Other relevant diagnostic data e.g., indications for testing 
• 
Time taken between specimen collection and sample processing on Q-POC 
 
12.4 Number of Specimens 
Nasal mid-turbinate swab (MTSW) samples from sufficient participants to achieve a minimum 
target at the end of the study of: 
• 
50 comparator test-confirmed SARS-CoV-2 positive samples  
• 
500 comparator test-confirmed SARS-CoV-2 negative samples 
Sample numbers chosen are in alignment with FDA recommendations in response to 
QuantuMDx’s pre-submission Q220638. 

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An adequate number of subjects (N=550) will be enrolled to achieve a minimum 50 
symptomatic positive and 500 negative cases confirmed via Roche Cobas 6800 SARS-CoV-2, a 
FDA approved reference standard.  
12.5 Specimen Storage, Handling, Transport, and Disposal 
Once recruited, a healthcare professional will take a sample per subject for the comparator 
test, following the manufacturer’s Instructions For Use (IFU) in one nostril. MTSW samples will 
be taken from the opposite nostril (that was not swabbed for the comparator NPS sample), 
using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the test under 
investigation. In instances where opposite nostrils cannot be swabbed for both the comparator 
and the test under investigation, a 15 minute wait period to allow for viral reloading must occur 
between collecting both the comparator and the test samples on the same nostril.  
Comparator RT-PCR samples will be shipped overnight with ice packs as they are collected and 
processed for testing within 48 hours of collection. Comparator RT-PCR samples will be stored 
frozen at -70oC to -80oC after testing; they will be defrosted and brought up to room 
temperature immediately before re-testing, if required. Test MTSW samples will tested as soon 
as possible following collection, however if time is required between specimen collection and 
testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be 
stored at 2-8 °C whilst the Q-POC test is running.   
Following testing (and any subsequent re-testing), residual samples will be stored between -
70oC to -80oC for retesting of any discordant results. Once the study is completed, the samples 
will be disposed of within biohazardous waste.  
13 Clinical Performance Study Procedures 
NPS samples will be tested on the Roche Cobas 6800 SARS-CoV-2 Test. A 400 µL aliquot of 
MTSW sample will be inserted into the Q-POC SARS-CoV-2 Assay test cassette and run on the 
Q-POC instrument. 
Test and comparator assays will be run on their respective sample types.  
13.1 Data Validity 
Upon completion of each Q-POC run, the instrument should display the test status as ‘VALID’. 
If any other test status is displayed, the run should be discarded. 
The comparator RT-PCR assay, Roche cobas® SARS-CoV-2, uses two SARS-CoV-2 nucleocapsid 
targets. Target 1 is specific to the SARS-CoV-2 virus, but Target 2 is a pan-Sarbecovirus region 
of the nucleocapsid that is conserved and detects both SARS-CoV-1 and SARS-CoV-2. This 
comparator RT-PCR assay considers samples which are positive for Target 1 as positive for 
SARS-CoV-2 virus regardless of the status of Target 2 which can be invalid, negative, or positive 

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and the sample is still SARS-CoV-2 positive if Target 1 is positive. If Target 2 is positive and 
Target 1 is either negative or invalid, then the result is a presumptive positive due to Target 2’s 
promiscuity among Sarbecovirus members. The decision has been made to consider all 
presumptive positive results as invalid for this clinical performance study. Only the result of 
“SARS-CoV-2 RNA detected”, according to the manufacturer’s instructions for use, will be 
counted as positive in the clinical performance evaluation data analysis.  
Any problems encountered during testing must also be communicated to the relevant 
facilitator(s) and to QuantuMDx. 
Any invalid tests should be repeated at least once. 
External Quality Controls will be run as per the Q-POC SARS-CoV-2 Assay product IFU and Roche 
cobas® SARS-CoV-2 IFU. External positive control runs must return positive results. External 
negative control runs must return negative results. If the incorrect result is returned, or the Q-
POC™ instrument displays one of these test statuses as ‘INVALID’, the controls should be re-
run. If repeats also fail, contact the facilitator(s) or QuantuMDx. 
13.2 Discordance Analysis 
Any discrepant results will be investigated via repeat testing using an alternative FDA approved 
RT-PCR test. Discrepant analysis will not be used to adjust PPA and NPA calculations. These 
results can only be used to provide further information in the product IFU or academic 
publications. Statistical analysis of test assay performance will be conducted to determine PPA 
and NPA. This will be based solely on comparison of Q-POC SARS-CoV-2 Assay and Roche Cobas 
6800 SARS-CoV-2 Test results. 
14 Monitoring Plan and Data Management 
Study monitoring shall ensure 
a) 
investigators adhere to the CPSP, 
b) 
study data are accurate and complete, and 
c) 
ethical conduct of the study, e.g. the rights and well-being of study subjects are 
protected. 
One or more qualified monitors shall be appointed. Monitors shall be: 
• 
qualified through training and experience as well as scientific or clinical knowledge, 
• 
knowledgeable on the specific activities to be monitored, the CPSP, and any other 
relevant requirements, and 
• 
trained on the relevant quality assurance procedures as well as any special procedures 
for monitoring a specific clinical performance study. Training shall be documented in 
the study master files. 

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Study data will be captured in the case report forms (CRFs) by the study staff. Paper forms will 
be filled in during the study and transcribed into electronic forms (smartsheet) which will feed 
into a spreadsheet. The paper forms will also be scanned and uploaded to the spreadsheet. 
Access to the data collection system will be provided to members of the study site who have 
been delegated data collection and entry responsibilities by the site PI and who have completed 
training on the EDC system. 
The data recorded in the CRFs will be source-verified from study-related source documents. 
Quality Control checks will take place to verify that the smartsheet MDF matches the scans of 
the paper source CRFs. The investigator shall ensure that all data on the CRFs are complete, 
accurate, and consistent with source documentation. A monitor from the Sponsor (or designee) 
will review the CRFs for completeness and accuracy. 
The investigator will anonymise patient data so that no identifiable information is kept. Data 
arising from the administration of the index and reference tests, e.g. graphs and other outputs 
will be collected. All data related to the evaluation will be stored; raw and unanalysed data files 
will be shared with QuantuMDx. 
15 Statistical Considerations 
The diagnostic performance of the Q-POC SARS-CoV-2 Assay (in terms of PPA and NPA) will be 
determined using the Roche Cobas 6800 SARS-CoV-2 Test, as an FDA-approved reference 
standard comparator assay. This will be done for the entire dataset and also for subsets 
classified by comparator Ct-banding (Ct≤25, 25<Ct≤30, Ct>30) for SARS-CoV-2. Diagnostic 
performance will be assessed as follows: 
• 
Positive Percent Agreement (PPA) will be calculated as 100% × (TP/(TP + FN)).  
• 
Negative Percent Agreement (NPA) will be calculated as 100% × (TN/(TN + FP)).  
• 
PPA and NPA will include 95% CI. 
Where:  
• 
True Positive (TP) indicates that both the Q-POC SARS-CoV-2 Assay and comparator 
assay returned a positive result for the target. 
• 
False Negative (FN) indicates that the Q-POC SARS-CoV-2 Assay returned a negative 
result for the target, while the comparator assay returned a positive result. 
• 
True Negative (TN) indicates that both the Q-POC SARS-CoV-2 Assay and comparator 
assay returned a negative result for the target. 
• 
False Positive (FP) indicates that the Q-POC SARS-CoV-2 Assay returned a positive result 
for the target, while the comparator assay returned a negative result. 
The performance of the Q-POC SARS-CoV-2 Assay will be presented based on the overall study 
(all specimens of a claimed specimen type combined) as well as stratified by site and time since 
symptom onset.  

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The rate of invalid/indeterminate results observed during the clinical study by site and overall 
will be reported. The prevalence of infection observed at each clinical site as determined by 
the comparator and the detection rate by the Q-POC SARS-CoV-2 Assay separately will be 
reported. 
 
16 Deviations from the Clinical Performance Study Plan 
The investigator is not allowed to deviate from the CPSP, except when a deviation is necessary 
to protect subject’s rights, safety and well-being, or the scientific integrity of the clinical 
performance study. 
Should a deviation from the clinical performance study plan be required, this will be 
communicated to QuantuMDx, QuantuMDx will record the deviation in a Deviation Record 
Template Form (QTEM-270) and circulated for approval with the relevant stakeholders. All 
deviations will be explained and referenced in the Clinical Performance Study Report. Should 
there be any major and/or repeated deviations, these will be recorded and corrective and 
preventative actions implemented via the Control of Non-Conforming Product Procedure 
(QQA-14).  
17 Accountability of the IVD Medical Devices under Investigation 
Access to IVD medical devices under investigation shall be controlled and these devices shall 
be used only in the clinical performance study according to this Clinical Performance Study Plan 
(QVTP-39). 
The sponsor shall keep records to document the physical location of all IVD medical devices 
under investigation from shipment of the devices to the study site until return or disposal. 
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the IVD medical devices under investigation, which shall 
include, when applicable: 
a) The date of receipt 
b) The identification of each Q-POC instrument via serial number and Q-POC SARS-CoV-2 
Assay Test cassettes via batch number 
c) The expiry date of the Q-POC SARS-CoV-2 Assay Test Cassettes 
d) The dates of use 
e) The date on which the devices under investigation were returned or disposed of 
f) The date of return of unused, expired or malfunctioning devices under investigation 

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18 Statements of Conformity 
The clinical performance study outlined in this plan (QVTP-39) shall be conducted in accordance 
with relevant local and national ethical principles. 
The clinical performance study outlined in this plan (QVTP-39) should comply with the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations and should ensure 
compliance with all other pertinent laws and regulations, including Occupational Health and 
Safety Administration (OSHA) regulations pertaining to biological hazards (“universal 
precautions”). 
The clinical performance study outlined in this plan (QVTP-33) shall not begin until the required 
approval/favourable opinion or waiver from the ethics committee and/or regulatory authority 
has been obtained, when applicable.  
19 Informed Consent Process 
Informed consent is documented by means of a written, signed and dated informed consent 
form. The default personal information collected on the consent form is Name and Date of 
Birth. 
All individuals asked to consider taking part in research must be given information about the 
research, presented in terms and in a form that they can understand. The participant must sign 
and date this sheet to show they have read and understood it. 
The Designated Individual (DI) or Person Designated (PD), in the DI's absence, will arrange for 
an informed consent session prior to the donation of any sample. For external volunteers, an 
online informed consent session or phone call will be held prior to the donation of any sample. 
Informed consent is recorded on the relevant form and once the DI/PD and the volunteer are 
happy that informed consent has been given, the sample will be obtained and labelled with the 
Sample ID assigned to the consent form. 
A scanned copy of the signed informed consent form must be added to the secure HTA server 
and the original hard copy to be stored with the DI. It is the responsibility of the DI/PD to ensure 
this takes place. Once inputted into the database, only the person’s Sample ID must be used in 
all lab books, data files etc. Personal information on the donor must not be referred to. 
A new consent form MUST be completed for each new donation a participant consents to. 

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20 Adverse Events, Adverse Device Effects and Device 
Deficiencies 
All applicable adverse events shall be reported in an interim or final report of the clinical 
performance study and reported in compliance with the Federal Food, Drug, and Cosmetic Act 
(FD&C Act).