Repeat Saliva Testing for SARS-CoV-2 Using RT-LAMP Assay
Phase: NA
Conditions: COVID-19, Sars-CoV-2
Sponsor: University of Wisconsin, Madison

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[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 1 of 1 
 
1.0 
STATEMENT OF COMPLIANCE 
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment.  
 
Name 
Signature 
Date 
 
 
__________________________________ 
_____________________________ 
___________________ 
Principal investigator 
 
 
__________________________________ 
_____________________________ 
___________________ 
Sponsor 
 
 
 
 
 
 

[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 1 of 1 
 
2.0 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
AVRL 
AIDS Vaccine Research Laboratory 
BSC 
Biological Safety Cabinet 
CCC 
Clinical Coordinating Center 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTMS 
Clinical Trial Management Software 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DMC 
Data Monitoring Committee 
EtOH 
Ethyl alcohol 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IDE 
Investigational Device Exemption 
ICTR 
Institute for Clinical and Translational Research 
IRB 
Institutional Review Board 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
POC 
Point of Contact 
RT-LAMP 
Reverse transcription loop-mediated isothermal amplification 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SMP 
Study Monitoring Plan 
SMS 
Study Monitoring Service 
UP 
Unanticipated Problem 
UWCCC 
University of Wisconsin Carbone Cancer Center 
 

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[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 2 of 21 
 
Endpoints 
When we have tested at least 10000 samples and consistently shown that the assay can detect 
SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile 
laboratory and can be organized to test participants repeatedly over time.  
Study Design 
This is a non-randomized study where every participant will undergo the same procedure of 
spitting into a tube. 
IND or IDE 
Number 
Requesting a nonsignificant risk (NSR) determination from the IRB.  
Study 
Intervention 
The RT-LAMP assay detects SARS-CoV-2 RNA in saliva samples using Salus Discovery 
LLC’s RNA extraction technology. 
Total Number of 
Subjects 
A total of 10000 subjects could be recruited from the study sites. 
Study Population 
Anyone over the age of 5yrs old with consent to provide a saliva sample will be eligible to 
participate.  
Estimated 
Subject Duration 
The duration of the study for each subject is approximately 20 minutes each visit. 
Estimated 
Enrollment 
Period & Study 
Duration 
Study enrollment will occur over a 12 month period.  
 
 
 

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A$*%G&''8!&''!76A"@P0c!BO3!&++&8+!*)SG$*)!:)#%*&'$U)4!'&D,*&%,*$)+.!9&IH')+!:,''):%)4!$#!',:&%$,#+
$#:'G4$#5!HGD'$:!%)+%$#5!+$%)+T!L,*VH'&:)+T!#G*+$#5!;,I)+T!&#4!*)+$4)#%$&'!;,G+$#5!&*)!%*&#+H,*%)4!%,!

[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 5 of 21 
 
centralized laboratories for testing, leading to lengthy delays in results reporting. The window of maximal   
contagiousness is thought to be only a few days, so these delays create the risk of excess transmission. 
Current testing methods are painful, which encourages testing hesitancy. Rapid, onsite detection of SARS-
CoV-2 RNA from non-invasive saliva could overcome these issues and provide a pathway to high-
throughput detection of people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a 
testing program require real-world prototyping. That is the purpose of this project. 
 
Shown below are RT-LAMP results using residual specimens from known SARS-CoV-2+ cases. Each 
vertical series of points is a different sample, the datapoints for each sample indicate performance with a 
different primer set (a variable that we were optimizing in this experiment). You’ll note that all of these 
samples were detected with our RT-LAMP assay. There was one sample that didn’t perform well with every 
primer set (the one with the least amount of virus, Ct ~ 30), but this sample had the lowest amount of input 
virus. 
 
 
 
 
False positives are rare to non-existent. Early in our RT-LAMP testing, we received blinded samples from 
the State Lab of Hygiene. 15/15 SARS-CoV-2-negative samples were properly classified. 14/15 SARS-
CoV-2+ samples were properly classified. This was an early embodiment of the technology and the one 
sample that was a false negative also had a Ct ~ 30, corresponding to the low end of what we reasonably 
expect to detect right now: 
 
 

[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 6 of 21 
 
 
 
Will this assay generate a lot of false positives? No. Could it generate some false negatives, especially for 
people who have low amounts of virus and are not thought to be contagious? Yes, and that is explicitly what 
we aim to learn as we bring this test into the “real-world”. Can a test that identifies people who are 
contagious be useful even if it isn’t as sensitive as a diagnostic test? 
 
6.0 
STUDY OBJECTIVES AND ENDPOINTS 
  
Objectives 
Endpoints 
Primary 
To show that performing high-frequency, rapid-
turnaround surveillance testing with this assay is feasible 
and able to be optimized to enable isolation and follow-
up diagnostic testing.  To also understand if participants 
will adhere to the recommendations of isolation and 
follow-up testing and if they will provide samples on a 
consistent, frequent basis or develop testing fatigue. 
 
When we have tested at least 10000 samples and can 
show that high-frequency, rapid turn-around 
surveillance testing is feasible and able to be 
optimized for isolation and follow-up diagnostic 
testing. When we can show that it can be simplified so 
minimally trained staff can perform it successfully. 

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[Repeated Testing for SARS-CoV-2] 
 
[O’Connor] 
 
 
 
Version #: [2] 
Version Date: [10/16/2020] 
Page 11 of 21 
 
The informed consent process will be performed as follows: 
● Collection sites are being asked to provide the following: a relatively secluded approximately 10 foot 
x 10 foot workspace where sample processing can be performed, as well as a secondary location at 
least 20 feet away where volunteers can review the consent form, provide informed consent, and 
self-collect saliva samples. The study team will adhere to current public health guidelines when 
setting up testing stations.   
● A study team member will review the informed consent form and discuss the study in detail with the 
potential research subject including any minors with their parents/legal guardians. 
● A study team member will explain the study, its risks and benefits, what would be required of the 
research subject, and alternatives to participation. 
● The research subject will be given the opportunity to read the informed consent/assent form and ask 
questions and have all questions answered by the study team member.  
● The informed consent/assent document must be signed and dated by the research subject. 
● The study team member will review the informed consent/assent document to ensure that all fields 
that require a response are complete (i.e., checkbox marked yes or no, etc.) as applicable. The 
research subject will be given the opportunity to take a picture of their signed and dated informed 
consent/assent form for their records. They will be given the opportunity to take a blank paper copy 
of the consent form as well. The original signed informed consent form is kept in a locked box while 
the study team is at the sample collection site and then transported to the AIDS Vaccine Research 
Laboratory where it will be stored in a locked filing cabinet within the locked building that has 
limited and controlled access 
● A study team member will explain the study to minors at an age appropriate level and: 
o Minors between the ages of 15-17 years old must sign a Consent Form AND have a parent/legal 
guardian sign a Parental Consent Form.  
o Minors between the ages of 8-14 years must sign an Assent Form AND have a parent/legal 
guardian sign a Parental Consent Form. 
o Minors between the ages of 5-7 years must have the study explained to them in age appropriate 
language AND have a parent/legal guardian sign a Parental Consent Form. 
  
Adults 18 yrs and older 
Must sign a Consent Form. 
Minors 15 yrs to 17 yrs 
Must sign a Consent Form after having the study explained to 
them AND have a parent/legal guardian sign a Parental 
Consent Form. 
Minors 8 yrs to 14 yrs 
Must sign an Assent Form after having the study explained to 
them AND have a parent/legal guardian sign a Parental 
Consent Form. 
Minors 5 yrs to 7 yrs 
Must have the study explained to them AND have a 
parent/legal guardian sign a Parental Consent Form. 
10.1.2 Enrollment 
A research subject will be defined as “enrolled” in the study when they meet the following criteria: 
● The subject has been consented by a study team member. 
● The subject has provided at least one saliva sample.  
Participants may provide a saliva sample as many times as they want for the duration of the study. Informed 
consent will only be performed once.   

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