Usability Study of Home Collection and Mailing With SARS-CoV-2 Test Specimen Collection Materials (2020-06)
Conditions: COVID-19
Sponsor: Exact Sciences Corporation

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Protocol 2020-06 v1.0 
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Usability Study of Home Collection and Mailing 
with SARS-CoV-2 Test Specimen Collection 
Materials (2020-06) 
 
 
Study Title: 
Usability Study of Home Collection and Mailing with SARS-CoV-2 Test Specimen 
Collection Materials (2020-06) 
Study Number: 
2020-06 
Version and Date: 
Protocol Version 1.0, May 7, 2020 
Study Sponsor: 
Exact Sciences Laboratories 
145 E. Badger Road 
Madison, WI 53719 
Sponsor Contact: 
 
 

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Table of Contents 
1 
LIST OF ABBREVIATIONS .................................................................................................................... 4 
2 
PROTOCOL SYNOPSIS ........................................................................................................................ 5 
3 
BACKGROUND / RATIONALE .............................................................................................................. 6 
3.1 
SARS-CoV-2 Testing in the United States .................................................................................... 6 
3.2 
Usability of the SARS-CoV-2 Test Specimen Collection Materials ................................................ 7 
4 
OBJECTIVES AND ENDPOINTS .......................................................................................................... 7 
4.1 
Objectives ...................................................................................................................................... 7 
4.1.1 
Primary Objective ...................................................................................................................... 7 
4.1.2 
Secondary Objective .................................................................................................................. 7 
4.2 
Endpoints ....................................................................................................................................... 7 
4.2.1 
Primary Endpoint ....................................................................................................................... 7 
4.3 
Other Pre-Specified Analyses ........................................................................................................ 7 
5 
STUDY DESIGN .................................................................................................................................... 8 
6 
STUDY MATERIALS .............................................................................................................................. 8 
6.1 
SARS-CoV-2 Specimen Collection Materials ................................................................................ 8 
6.2 
Critical Tasks for the SARS-CoV-2 Specimen Collection Materials ............................................... 8 
7 
SUBJECT SELECTION AND WITHDRAWAL ..................................................................................... 10 
7.1 
Inclusion Criteria .......................................................................................................................... 10 
7.2 
Exclusion Criteria ......................................................................................................................... 10 
7.3 
Subject Withdrawal ...................................................................................................................... 10 
8 
STUDY PROCEDURES ....................................................................................................................... 11 
8.1 
Overview ...................................................................................................................................... 11 
8.2 
Enrollment.................................................................................................................................... 11 
8.3 
Observation for Problems Using SARS-CoV-2 Test Specimen Collection Materials ................... 11 
8.4 
Subject Experience with SARS-CoV-2 Specimen Collection Materials ....................................... 12 
8.5 
SARS-CoV-2 Testing of Subject Samples ................................................................................... 12 
8.6 
Data Collection ............................................................................................................................ 12 
8.6.1 
Subject Reported Data ............................................................................................................. 13 
8.6.2 
Observer Reported Data .......................................................................................................... 13 
8.6.3 
Lab and Test-Related Data ...................................................................................................... 13 
8.7 
End of Study ................................................................................................................................ 13 
8.8 
Sample Retention ........................................................................................................................ 13 

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9 
DATA ANALYSIS AND STATISTICAL METHODS .............................................................................. 13 
9.1 
Sample Size Determination ......................................................................................................... 13 
9.2 
Analysis of Primary Endpoint ....................................................................................................... 14 
9.3 
Other Pre-Specified Analyses ...................................................................................................... 14 
9.4 
Analytic Cohort ............................................................................................................................ 14 
9.5 
Stopping Rule .............................................................................................................................. 14 
9.6 
Bias Considerations ..................................................................................................................... 15 
9.7 
Handling of Missing Data ............................................................................................................. 15 
10 ADVERSE EVENT REPORTING ......................................................................................................... 15 
10.1 
Definition of Adverse Events ........................................................................................................ 15 
10.2 
Reporting Period .......................................................................................................................... 15 
10.3 
Serious Adverse Events .............................................................................................................. 15 
11 QUALITY CONTROL AND QUALITY ASSURANCE ........................................................................... 15 
12 DATA HANDLING AND RECORD KEEPING ...................................................................................... 16 
12.1 
Protocol Deviations ...................................................................................................................... 16 
12.2 
Case Report Forms (CRFs) ......................................................................................................... 16 
12.3 
Records Retention ....................................................................................................................... 16 
13 ETHICS ................................................................................................................................................ 16 
13.1 
Risk Analysis ............................................................................................................................... 16 
13.1.1 
Risk to the subject ............................................................................................................... 16 
13.1.2 
Benefit to Subject ................................................................................................................. 17 
13.2 
Institutional Review Board (IRB) / Ethics Committee (EC) .......................................................... 17 
13.3 
Ethical Conduct of the Study ........................................................................................................ 17 
13.4 
Subject Information and Consent ................................................................................................ 17 
14 DEFINITION OF END STUDY ............................................................................................................. 17 
15 SPONSOR DISCONTINUATION CRITERIA ....................................................................................... 17 
16 REFERENCES ..................................................................................................................................... 18 
APPENDIX 1.0 – SCHEDULE OF ACTIVITIES .......................................................................................... 19 
APPENDIX 2.0 – IFU FROM SARS-CoV-2 TEST SPECIMEN COLLECTION MATERIALS ...................... 20 
APPENDIX 3.0 – FORMS FOR DATA TO BE COLLECTED ...................................................................... 21 

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1 
LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
2019-nCoV 
2019 Novel Coronavirus (see also SARS-CoV-2) 
AE 
Adverse Event 
ASQ 
After-Scenario Questionnaire 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
COVID-19 
Coronavirus disease 2019 
CRF 
Case Report Form 
ESL 
Exact Sciences Laboratories 
EUA 
Emergency Use Authorization 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
RT-PCR 
Reverse transcription polymerase chain reaction 
SAE 
Serious Adverse Event 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 (see also 2019-nCoV) 

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2 
PROTOCOL SYNOPSIS 
Primary Objective: 
Determine the usability of the SARS-CoV-2 Specimen 
Collection Materials for at-home collection and mailing 
of sample to the testing laboratory 
Study Design: 
Prospective observational human factors usability study 
Population: 
Subjects of varying education levels, age, and health 
status 
 
Subjects are considered enrolled when they provide 
written informed consent. 
 
Approximately 30 subjects are targeted for enrollment. 
 
Primary Endpoint: 
The primary endpoint is the percent of samples from 
the fully enrolled cohort to return a valid SARS-CoV-2 
test result (positive, not detected, or inconclusive). The 
target is 80% as an acceptable rate of success given 
the first-time task completion for minimally trained 
users. 
 
Study Duration: 
The study will be complete when approximately 30 self- 
collected nasal swab samples have corresponding 
SARS-CoV-2 test results (positive, not detected, 
inconclusive, invalid, or unable to be processed). 
 
Subject participation is up to one day from enrollment to 
completion. 
 
Study Procedures: 
Subjects will be observed while following the 
Instructions for Use (IFU) for the SARS-CoV-2 
Specimen Collection Materials in a setting that 
simulates a home environment. 
 
Subjects will take the After-Scenario Questionnaire 
(ASQ) to measure ease of use. 
 
Subjects will have the opportunity to provide written 
feedback on their experience. 
 
Subjects will be asked questions about their 
comprehension of the IFU by the observer. 

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The specimens collected by the subject will be tested 
in the laboratory for SARS-CoV-2. Subjects will remain 
blinded to the results of the study sample. 
 
Subject data will be collected and provided to the 
Sponsor. 
 
 
3 
BACKGROUND / RATIONALE 
3.1 
SARS-CoV-2 Testing in the United States 
The Centers for Disease Control and Prevention (CDC) in the United States suggests laboratory testing 
to identify the SARS-CoV-2 virus that causes COVID-19. The Food and Drug Administration (FDA) has 
given Emergency Use Authorization (EUA) for select Real-Time RT-PCR Diagnostic Panels that detect 
RNA specific to SARS-CoV-2. This study will use the Exact Sciences Laboratories (ESL) SARS-CoV-2 (N 
gene detection) Test 
  
 
 
 
 
, 
 
 
The ESL SARS-CoV-2 (N gene detection) Test provides a qualitative result based on detection of RNA. 
The test measures the presence of two regions of the RNA related to the SARS-CoV-2 nucleocapsid 
protein N gene (N1 and N2), which are specific for this virus. Both N1 and N2 RNA must be detected for a 
positive result and are indicative of active infection by the virus. A positive result does not rule out other 
infections. Detection of only one of the two viral RNAs results in an Inconclusive test. Negative results  
(Not detected) do not rule out infection and should be used in combination with clinical and 
epidemiological information for patient management decisions. The ESL SARS-CoV-2 (N gene detection) 
Test also measures RNA related to ribonuclease P, which is a human protein and acts as an internal 
reference. The absence of the viral and human RNA would lead to an invalid test result. 
 
SARS-CoV-2 
N1 
SARS-CoV-2 
N2 
Human 
RNase P 
Report Result 
Next Step 
+ 
+ 
+/- 
Positive 
N/A 
one +, one - 
+/- 
Inconclusive 
Sample sent for alternative testing 
- 
- 
+ 
Not Detected 
N/A 
- 
- 
- 
Invalid 
Specimen inadequate. Recollect if 
clinically indicated. 
Table 1: Possible ESL SARS-CoV-2 (N gene detection) Test results based on RNA detected. 
 
While the CDC provides guidelines for the collection of a wide range of upper and lower respiratory 
samples, the ESL SARS-CoV-2 (N gene detection) Test is for use with upper respiratory (nasal swab) 
samples from subjects receiving a clinically indicated COVID-19 Test.[1] The use of the nasal swab that 
meets CDC recommendations has advantages, including avoiding the supply issues for specialized 
sample collection devices, such as the nasopharyngeal swab. Sample collection is also easier with a 
nasal swab. While the supply shortages could be transient, the collection methods of washes and 
aspirates potentially increase the risk of exposure for healthcare workers.[2] 

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Emphasis has been placed on increasing overall testing availability, and the access to at home SARS- 
CoV-2 specimen collection (without healthcare worker supervision) will significantly improve the 
effectiveness of public health tools in preventing spread of the disease during this pandemic in the United 
States. 
3.2 
Usability of the SARS-CoV-2 Test Specimen Collection Materials 
The SARS-CoV-2 Specimen Collection Materials (Section 6) allow for self-collection of a nasal swab 
specimen and return to a testing laboratory, which will enable at home collection. The Materials include 
Instructions for Use (IFU), which are a straightforward, step-by-step guide. The usability of the IFU is a 
critical factor in the success of at-home testing and is the focus of this clinical study. An IFU with a high 
completion rate that provides samples with sufficient quality and quantity of specimen for SARS-CoV-2 
testing is necessary. 
4 OBJECTIVES AND ENDPOINTS 
4.1 
Objectives 
4.1.1 
Primary Objective 
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for 
at-home collection and mailing of sample to the testing laboratory. 
4.1.2 
Secondary Objective 
The secondary objectives of this study are to evaluate perceived usability of the IFU as well as 
comprehension by the subject, identify problems (e.g., use errors, delays, close calls) that occur while 
following the IFU, evaluate root causes of problems, and develop strategies to mitigate those risks going 
forward. 
4.2 
Endpoints 
4.2.1 
Primary Endpoint 
The primary endpoint is the percent of samples from the fully enrolled cohort to return a valid SARS-CoV- 
2 test result (positive, not detected, or inconclusive). The target is 80% as an acceptable rate of success 
given the first-time task completion for minimally trained users. 
4.3 
Other Pre-Specified Analyses 
Other pre-specified analyses include 
• 
characterization of subjects’ self-reported ease of use of the Specimen Collection Materials, 
• 
acceptable answers on general comprehension of the IFU, 
• 
observer-reported problems associated with following the IFU, 
• 
j
 
g 
 
g   
• 
 
 
 
 
 
 
 
• 
evaluation of root causes of problems associated with user tasks, including but not limited to 
critical tasks, to develop risk mitigation strategies. 

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5 
STUDY DESIGN 
This study is a prospective observational human factors usability study designed to evaluate the IFU in 
the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of 
a nasal swab sample, which includes a valid SARS-CoV-2 test result. 
Subjects with a range of education levels and ages but without medical, laboratory, or COVID-19 
specimen self-collection experience will be recruited. Subject participation is up to one day from 
enrollment to completion. The specimens collected by the subjects will be tested in the laboratory for 
SARS-CoV-2. Subjects will remain blinded to the test results. The study will be considered complete 
when approximately 30 self-collected nasal swab samples have corresponding SARS-CoV-2 test results 
(positive, not detected, inconclusive, invalid, or unable to be processed). 
 
 
6 
STUDY MATERIALS 
6.1 
SARS-CoV-2 Specimen Collection Materials 
The SARS-CoV-2 Specimen Collection Materials is a single-use convenience kit comprised of a sterile 
individually wrapped nasal swab (polyester tip with plastic handle) and a 2 ml transport tube with 0.9% 
saline transport medium, packaged together in a single container not intended to be unwrapped or 
unsealed before it is used by the end user, an individual undergoing testing for COVID-19. A biohazard 
bag, absorbent pad, and UN3373-labelled shipping container are also provided. Instructions for Use (IFU) 
are also provided (Appendix 2.0). The SARS-CoV-2 Specimen Collection Materials is for use outside of a 
clinical setting. 
6.2 
Critical Tasks for the SARS-CoV-2 Specimen Collection Materials 
A Use-Related Failure Modes Effect Analysis (FMEA) approach was used to determine potential hazards 
and their associated risks during use of the SARS-CoV-2 Specimen Collection Materials. For each 
activity, the following high-level questions were asked: 
 
Do users correctly collect nasal swab samples? 
 
Do users correctly prepare samples for shipment? 
 
Do other aspects of use of the SARS-CoV-2 Specimen Collection Materials impact the receipt of 
usable nasal swab samples at ESL? 
 
How easy or difficult is it to understand and use the IFU in the SARS-CoV-2 Specimen Collection 
Materials to perform tasks? 
 
The activities in the workflow described in the IFU were used to determine tasks to be evaluated in this 
usability study. Each task was then assigned a rating of “critical” or “essential,” based on a human factors 
risk assessment done at Exact Sciences. Critical and essential tasks are defined as follows. 
 
Critical tasks are those in which use errors or failure to complete would have a negative clinical 
impact, such as inaccurate or delayed test results. 
o 
Failure to successfully complete a critical task results in a use error or performance 
failure. 
 
Essential tasks represent behaviors that are important to the overall use of the SARS-CoV-2 
Specimen Collection Materials but do not pose an immediate risk to the user. 

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Add swab to tube. 
Remove swab from 
tube. 
User does not swirl the swab 
long enough 
User does not press liquid 
out of swab 
Invalid test 
result 
False 
inconclusive test 
result 
Low 
Simulated use 
False negative 
result 
Medium 
Replace tube cap. 
User does not close the 
sample tube tightly and 
contents leak during 
shipment. 
No test result 
Low 
Simulated use 
Place label on tube 
User does not put label on 
tube 
No test result 
Low 
Simulated use 
Place bubble wrapped 
bag in box 
User does not pack tube in 
shipping box 
No test result 
Low 
Simulated use 
Store sample in sealed 
box away from direct 
heat and sunlight until 
shipment. 
User leaves sample in heat or 
sunlight. 
Invalid test 
result 
Low 
IFU 
comprehension 
questions 
False negative 
test result 
Medium 
Ship package by UPS 
User misses shipping pick-up 
User does not arrange for 
same day shipment 
User takes package to other 
shipping vendor or a UPS 
drop box 
No test result 
Lost sample 
Unusable sample 
Low 
IFU 
comprehension 
questions 
Table 2: Critical tasks identified as having potential to harm users or delay in treatment or diagnosis for users of 
the SARS-CoV-2 Specimen Collection Materials. 
 
7 
SUBJECT SELECTION AND WITHDRAWAL 
Each subject must meet all the following inclusion criteria and none of the exclusion criteria to participate 
in this study. 
7.1 
Inclusion Criteria 
1.  Ability to provide informed consent 
7.2 
Exclusion Criteria 
1. Prior medical or laboratory training 
2. Prior experience with COVID-19 specimen self-collection 
3. Prior SARS-CoV-2 testing 
7.3 
Subject Withdrawal 

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Subjects may be withdrawn from the study by any of the following mechanisms: 
• 
Voluntary withdrawal of participation by the subject at any time during the study. 
• 
Determination by the Investigator that it is in the best interest of the subject. 
• 
Determination by the Sponsor it is in the best interest of the subject or study. 
• 
Determination by review that the subject does not meet eligibility criteria. 
 
All data available from enrollment to subject withdrawal will be collected. Data for the study visit will be 
collected for subjects who discontinue participation but who do not withdraw consent. 
 
8 
STUDY PROCEDURES 
8.1 
Overview 
Subjects who provide informed consent will be observed while following the IFU for the SARS-CoV-2 
Specimen Collection Materials in a setting that simulates a large surface area, such as a kitchen or 
bathroom counter or a tabletop. The room will include common items such as hand sanitizer, pens, 
pencils, paper towels, and a wastebasket. In the event a sink is not available, a large bowl labeled “SINK” 
will be provided next to the hand sanitizer. Subjects will also provide feedback on the usability of the IFU 
by completing a survey, answer comprehension questions, provide written feedback on the experience, 
and address questions from the observer about problems during use. The observer will be an employee 
of Exact Sciences. 
 
 
 
8.2 
Enrollment 
Figure 1: Overview of study procedures. 
Inclusion and exclusion criteria will be reviewed. After subjects have provided written informed consent, 
demographic information will be obtained, and subject eligibility will be confirmed. 
Enrollment and the use of the device may occur on the same day. 
 
 
8.3 
Observation for Problems Using SARS-CoV-2 Test Specimen Collection Materials 
The subject will be provided with the SARS-CoV-2 Specimen Collection Materials that include the IFU. An 
observer will watch the subject perform the tasks in the IFU without providing input or assistance. The 
observer will record the following information by IFU task: 
• 
Completed 

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• 
Completed with use errors, close calls 

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• 
Did not complete 
• 
Free form observational notes 
 
 
8.4 
Subject Experience with SARS-CoV-2 Specimen Collection Materials 
Subjects will take a survey called the After-Scenario Questionnaire (ASQ) to evaluate perceived ease of 
use.[3-5] 
 
Figure 2: After-Scenario Questionnaire (ASQ) 
Subjects will have the opportunity to provide written feedback on their experience. 
Subjects will be asked questions about their experience by the observer, including their comprehension of 
the IFU (e.g., shipping instructions). Follow up questions to the subject by the observer may be needed to 
clarify areas of misunderstanding about the IFU. 
Finally, the observer will ask questions to help identify the root causes of tasks observed as not 
completed or completed with use errors or close calls during the simulation of the IFU. 
 
 
8.5 
SARS-CoV-2 Testing of Subject Samples 
For the IFU to be successful for at home testing, valid test results must result from self-collected sample. 
Valid SARS-CoV-2 test results are positive, not detected, and inconclusive (Table 1). In addition, the 
following will be determined. 
• 
 
 
 
 
 
 
 
 
 
 
 
 
8.6 
Data Collection 

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Subject data will be collected on Case Report Forms (CRFs) as subject and observer reported surveys 
and provided to the Sponsor. 
8.6.1 
Subject Reported Data 
• 
Name 
• 
Date of birth 
• 
Demographics 
• 
Responses to exclusion criteria 
• 
Usability survey (ASQ) 
• 
Written feedback on following the IFU 
• 
Responses to IFU comprehension questions 
• 
Responses to questions about IFU close calls or tasks not completed, documented by 
the observer 
8.6.2 
Observer Reported Data 
• 
Checklist based on workflow steps to record completion, completion with difficulty (e.g., 
use errors or close calls), and did not complete 
• 
Written notes for each task 
• 
Subject-reported answers to questions on IFU comprehension and issues following the 
IFU 
8.6.3 
Lab and Test-Related Data 
• 
Qualitative results for the SARS-CoV-2 test 
• 
 
 
 
 
  
 
g 
 
 
• 
( ) 
 
j
  
 
g 
g  
 
8.7 
End of Study 
Subjects’ participation will be considered completed following completion of the survey, forms, and 
potential interview with the observer or at the point of early termination as described in Section 7.3. 
8.8 
Sample Retention 
Samples may not be used in their entirety. Samples may be retained for purposes such as additional 
testing in this or alternative SARS-CoV-2 tests. Information from this additional testing may be used to 
inform study questions around laboratory QA processes or test improvement. Unused sample will be 
destroyed after 1 year or earlier. 
9 
DATA ANALYSIS AND STATISTICAL METHODS 
9.1 
Sample Size Determination 
Based on feedback from the US FDA on the Exact Sciences submission Pre-EUA PEUA200414 as well 
as the recent Laboratory Corporation of America (LabCorp) accelerated EUA for Test Number 139900, 
which included a self-collection validation, 30 patients will be targeted for enrollment in this study. Per 
FDA recommendation, an attempt will be made to enroll subjects of varying age and educational status. 

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9.2 
Analysis of Primary Endpoint 
The primary endpoint is the percent of samples from the fully enrolled cohort to return a valid SARS-CoV- 
2 test result (positive, not detected, or inconclusive). The target is 80% as an acceptable rate of success 
given the first-time task completion for minimally trained users. 
9.3 
Other Pre-Specified Analyses 
Other pre-specified analyses include a characterization of subjects’ self-reported ease of use with the 
Specimen Collection Materials Instructions for Use (IFU), acceptable answers on general comprehension 
of the IFU, observer-reported problems associated with following the IFU, 
 
 
 
 and evaluation of root causes of problems associated with user tasks, including but not 
limited to critical tasks. All analyses will be descriptive in nature. Frequency and percentage will be 
calculated for categorical measures and mean, standard deviation, median, and interquartile range will be 
calculated for continuous measures. 
The subject’s self-reported satisfaction and ease of using the IFU will be assessed using the After- 
Scenario Questionnaire (ASQ).[3, 4] The ASQ is a valid and reliable 3-item survey on user satisfaction 
associated with completing a task. Item response options are on a 7-point Likert scale where 1 = strongly 
agree and 7 = strongly disagree. An overall satisfaction score is calculated as the average of the non- 
missing responses to the items (theoretical range 1-7 with a lower score indicating higher satisfaction). 
The frequency and percentage of each response to all questions will be presented, along with the mean, 
standard deviation, median, and interquartile range of the overall score. In addition, the frequency and 
percentage of subjects with an overall score of 1 to 3 (indicating that the subject agrees to strongly 
agrees that they are satisfied) will be presented. An average of 3.5 or lower on the overall ASQ score will 
be considered acceptable self-reported user satisfaction. 
The frequency and percentage of correct vs. incorrect responses from the subject on questions around 
shipping and invalid tests consequences will be presented. 
The frequency and percentage of individual problems observed (by an external observer) with the 
Specimen Collection Materials IFU will be presented, along with the distribution of total number of 
problems overall and total number of problems on critical tasks (Section 6.2). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
A qualitative evaluation of results from the user reported data, external observer feedback on user 
interactions, and laboratory testing will be conducted to assess the root cause of problems and evaluate 
mitigating solutions, e.g., whether specific parts of the IFU should be modified. 
9.4 
Analytic Cohort 
All subjects enrolled in the study will be included in the analytic cohort. 
Demographic and subject disposition characteristics will be described using frequency and percentage for 
categorical measures and mean, standard deviation, median, and interquartile range for continuous 
measures. 
9.5 
Stopping Rule 

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This study is expected to run through its conclusion without premature termination. 
9.6 
Bias Considerations 
Subjects who participate in this study may not be wholly representative of those who would use a home 
collection kit for SARS-Cov-2 testing. Subjects with a range of education levels and ages but without 
medical, laboratory, or self-collection experience will be recruited. There are no other known bias 
considerations in this study design. 
9.7 
Handling of Missing Data 
Missing data will not be imputed. 
Per the published scoring guidelines for the ASQ, the overall score is calculated by taking the average of 
the non-missing items. 
All analyses will be described in the study Statistical Analysis Plan, which will supersede the methodology 
presented in the Study Protocol. Any deviations in the Statistical Analysis Plan will be recorded along with 
their rationale in the final study report, as appropriate. 
10 ADVERSE EVENT REPORTING 
10.1 Definition of Adverse Events 
An adverse event (AE) is any unfavorable or unintended sign, symptom, or disease temporally associated 
with the use of an investigational product or protocol-imposed intervention, regardless of attribution. All 
observed or volunteered adverse events regardless of suspected causal relationship to the investigational 
product(s) will be reported as described in the following sections. 
Potential side effects from routine nasal swabbing, including, but not limited to, acute epistaxis 
(nosebleed), sneezing, nasal redness, are not required to be reported to the Sponsor as adverse events. 
10.2 Reporting Period 
Adverse events collection begins at enrollment and ends after completion of the sample collection. 
Adverse events will only be recorded for events that occur during or are believed to be associated with 
the nasal swab sample collection procedures. All AEs will be reported on the adverse event page(s) of the 
CRF. 
10.3 Serious Adverse Events 
Serious adverse events are not expected for this study. In the event of an SAE, the event will be reported 
to the IRB per IRB standard operating procedure. 
 
 
11 QUALITY CONTROL AND QUALITY ASSURANCE 
The study site may be subject to review by the (IRB)/Ethics Committee (EC), and/or to quality assurance 
audits performed by Exact Sciences. 

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12 DATA HANDLING AND RECORD KEEPING 
All references to the Sponsor in this section include all designees e.g., Contract Research Organizations 
or Consultants acting on behalf of the Sponsor. 
12.1 Protocol Deviations 
The site should make all efforts not to deviate from any of the study procedures or requirements as 
described in this protocol, except where necessary to eliminate immediate risks to the subject(s). 
Any deviations from this protocol must be notified to the Sponsor and documented properly. Protocol 
deviations must also be reported to the IRB per IRB policy. 
12.2 Case Report Forms (CRFs) 
As used in this protocol, the term Case Report Form (CRF) should be understood to refer to either a 
paper form or an electronic data record or both, depending on the data collection method used in this 
study. 
A CRF is required and should be completed for each enrolled subject. The completed original CRFs are 
the sole property of Exact Sciences and should not be made available in any form to third parties, except 
for authorized representatives of Exact Sciences or appropriate regulatory authorities, without written 
permission from Exact Sciences. 
12.3 Records Retention 
The ICH E6(R2) Good Clinical Practice: Consolidated Guidance defines source documents as, "Original 
documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate copies, 
microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept 
at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial)." 
The Sponsor agrees to keep records, including the identity of all participating subjects, all original signed 
informed consent forms, copies of all CRFs, and adequate documentation of relevant correspondence 
(e.g., letters, meeting minutes, telephone calls reports). The Sponsor shall maintain study records for a 
period of 2 years after the latter of the following three dates: the date on which the investigation is 
terminated or completed, the date that the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product development protocol, or date 
provided in applicable national law. 
13 ETHICS 
13.1 Risk Analysis 
13.1.1 Risk to the subject 

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The risk to study subjects is minimal and are related to the use of the nasal swab collection materials. 
The nasal swab could cause mild discomfort or a short-term impact such as a nosebleed. While the saline 
in the collection tube could spill, the liquid is safe and of small volume. 
13.1.2 Benefit to Subject 
There are no benefits to the subjects enrolled in this study. 
13.2 Institutional Review Board (IRB) / Ethics Committee (EC) 
It is the responsibility of the Investigator to have prospective approval of the study protocol, protocol 
amendments, informed consent forms, and other relevant documents, e.g., recruitment advertisements, if 
applicable, from the IRB. All correspondence with the IRB/EC should be retained in the Investigator File. 
Copies of IRB approvals should be forwarded to Exact Sciences or designee. 
13.3 Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as well as the general 
principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human 
Subjects (Council for International Organizations of Medical Sciences 2002), the Declaration of Helsinki 
(World Medical Association), and applicable local regulatory requirements and laws. 
13.4 Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject names on any 
Sponsor forms, reports, publications, or in any other disclosures, except where required by laws. In case 
of data transfer, Exact Sciences will maintain high standards of confidentiality and protection of subject 
personal data. Subject name, contact information, and informed consent will be retained by Exact 
Sciences Clinical Affairs in a secure, limited access location, for the purpose of conducting and oversight 
of the clinical study. Subject protected health information, including name and date of birth, may be 
shared on a limited basis with Exact Sciences staff responsible for conducting data collection and 
analysis activities. 
The informed consent form must be in compliance with ICH GCP, local regulatory requirements, and legal 
requirements. The informed consent form used in this study, and any changes made during the study, 
must be prospectively approved by both the IRB/EC and Exact Sciences before use. 
The Investigator must ensure that each study subject, or his/her legally acceptable representative, is fully 
informed about the nature and objectives of the study and possible risks associated with participation. 
The Investigator, or a person designated by the Investigator, will obtain written informed consent from 
each subject or the subject's legally acceptable representative before any study-specific activity is 
performed. The Investigator will retain the original of each subject's signed consent form. 
14 DEFINITION OF END STUDY 
End of Study is defined when the enrollment target of approximately 30 subjects has been achieved and 
all samples have been collected, processed, and tested. 
 
15 SPONSOR DISCONTINUATION CRITERIA 

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Premature termination of this study may occur because of a regulatory authority decision, change in 
opinion of the IRB, or at the discretion of Exact Sciences. 
16 REFERENCES 
1. 
Centers for Disease Control and Prevention (US). Interim Guidelines for Collecting, Handling, and 
Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19). 2020 [cited 
2020 April 8]; Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical- 
specimens.html. 
2. 
Centers for Disease Control and Prevention (US). Interim U.S. Guidance for Risk Assessment 
and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare 
Setting to Patients with Coronavirus Disease (COVID-19). 2020 [cited 2020 April 5]; Available 
from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. 
3. 
Lewis, J.R., IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and 
Instructions for Use. International Journal of Human-Computer Interaction, 1995. 7: p. 57-78. 
4. 
Lewis, J.R., Psychometric evaluation of an after-scenario questionnaire for computer usability 
studies: The ASQ. ACM SIGCHI Bulletin, 1991. 23: p. 78-81. 
5. 
Sauro, J. and J.R. Lewis, Quantifying the User Experience Practical Statistics for Research. 
2012, San Francisco, CA: Morgan Kaufmann Publishers Inc. 

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APPENDIX 1.0 – SCHEDULE OF ACTIVITIES 
 
Activity 
Observed Sample 
Collection 
Informed Consent1 
X 
Subject Completed Demographics and Exclusion Criteria 
X 
Use of SARS-CoV-2 Specimen Collection Materials while under observation 
X 
Complete the After-Scenario Questionnaire (ASQ) 
X 
Answer observer questions about comprehension of IFU and observations 
X 
Footnotes for Schedule of Activities 
1. Informed Consent must occur prior to undergoing any study specific procedures 

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APPENDIX 2.0 – IFU FROM SARS-CoV-2 TEST SPECIMEN COLLECTION MATERIALS 
IFU from the SARS-CoV-2 Test Specimen Collection Materials are provided as a supplement to the 
clinical study protocol. 

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APPENDIX 3.0 – FORMS FOR DATA TO BE COLLECTED 
Subject Demographics 
• 
Education level 
o 
No high school 
o 
Some high school 
o 
High school 
o 
College degree 
o 
Advanced degree 
• 
Date of birth 
• 
Race/ethnicity 
• 
Gender 
Inclusion/Exclusion Criteria Form 
• 
Participants with prior medical or laboratory training should be excluded. 
• 
Participants who have prior experience with self-collection should be excluded. 
• 
Participants who have previous SARS-CoV-2 testing should be excluded. 
Subject ease of use survey 
• 
After–Scenario Questionnaire (ASQ) 
Other subject-reported data 
• 
Survey for written comments 
o 
What, if any, steps did you have trouble completing? 
o 
Do you have suggestions for improving the collection instructions? 
• 
Questions to evaluate comprehension of the IFU 
o 
Follow up by observer if necessary 
• 
Subject-specific questions about not completed tasks and tasks completed with use errors or 
close during observation 
Observer 
• 
Observer Script 
• 
Checklist based on tasks in the SARS-CoV-2 Specimen Collection Materials which documents 
the following outcomes with free fields for observational notes: 
o 
Completed 
o 
Completed with use errors, close calls 
o 
Did not complete