COVID SAFE 2.0: COVID-19 Screening Program
Conditions: COVID-19
Sponsor: University of Pennsylvania

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COVID SAFE 2.0  
COVID-19 Screening Program 
Study Protocol 
MPIs:  
Rinad Beidas, PhD 
Scott Sherril-Mix, PhD 
Arupa Ganguly, PhD 
NCT05216627

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Outline 
1. Abstract 
2. Overall objectives 
3. Aims 
 
3.1 Primary outcome 
 
3.2 Secondary outcomes 
4. Background 
5. Study design 
 
5.1 Design 
 
5.2 Study duration 
 
5.3 Target population 
 
5.4 Accrual 
 
5.5 Key inclusion criteria 
 
5.6 Key exclusion criteria 
6. Subject recruitment 
7. Subject compensation 
8. Study procedures 
 
8.1 Consent 
 
8.2 Procedures 
9. Analysis plan 
10. Investigators 
11. Human research protection 
 
11.1 Data confidentiality 
 
11.2 Subject confidentiality 
 
11.3 Subject privacy 

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11.4 Data disclosure 
 
11.5 Data safety and monitoring 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
 
 
11.6.2 Potential study benefits 
 
 
11.6.3 Risk/benefit assessment 
12. Bibliography  
 

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1. Abstract 
In view of the recent COVID surge and difficulties in obtaining testing, we aim to increase Point 
of Care (POC) testing, whereby University of Pennsylvania (Penn) faculty, staff, and trainees 
who are working in person at Perelman School of Medicine (PSOM) laboratories can self-test. 
The purpose of this study is to evaluate the implementation of this POC testing program. We will 
not be collecting any samples as part of this study. This will ensure that individuals can rapidly 
identify if they have COVID-19 while balancing use, acceptability, appropriateness, and 
feasibility. We will start with a pilot phase whereby we will evaluate the implementation of a 
POC version of COVID-19 screening program that will coordinate several existing systems at 
the University of Pennsylvania including voluntary, self-administered saliva-based viral testing. 
We will pilot this program to a small cohort of PSOM labs and then test implementation of the 
self-testing of the POC version of COVID-19 screening across all PSOM labs for those who 
wish to participate. All results will be self-reported and will not be used to validate any tests or 
support any future approval from the FDA. No data from this study will go into the participants’ 
EMR.  
2. Overall objectives 
The primary objective of the study is to evaluate the use, acceptability, appropriateness, and 
feasibility of implementing a voluntary COVID-19 Point of Care (POC) screening program with 
Penn faculty, staff, and trainees that uses saliva-based self-collection followed by testing in their 
own PSOM laboratories. A secondary objective is to learn about self-reported test results, 
program usability, user burden, participant experience, program ease, program continuation and 
availability. Another secondary objective is to learn about individual’s perspectives about the 
program. 
3. Aims 
 
3.1 Primary outcome 
 
The primary implementation outcomes include self-reported quantitative survey data 
from Penn faculty, staff, and trainees related to use, acceptability, appropriateness, and feasibility 
collected weekly. We will collect this data for up to four weeks. 
 
3.2 Secondary outcomes 
 
The secondary implementation outcomes include self-reported quantitative survey data 
about test results, program usability, user burden, participant experience, program ease, program 
continuation and availability. Secondary outcomes also include qualitative data about 
participants’ perspectives of the program implementation and change in behavior or decision-
making process, which will be collected during virtual interviews conducted after primary data 
collection has completed.   

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4. Background 
The coronavirus disease (COVID-19) pandemic has resulted in close to 300,000,000 reported 
cases worldwide, including more than 58,000,000 reported cases and 800,000 deaths in the 
United States [1,2]. Initial efforts to address the COVID-19 pandemic were aimed at testing 
symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity 
to meet surge demands [3]. Currently, we are going through an unprecedented surge in the total 
number of cases – mostly due to the spread of the Omicron variant. While we continue to 
confront the current crisis, a complete lockdown as seen in 2020 is not desirable or being 
planned. We must address the current issue and also plan for the future by putting in place tools 
to enhance our ability to conduct effective screening, containment, and case management. Future 
variants may cause similar delays in testing availability.  
Widespread COVID-19 testing is needed to safely and effectively operate schools, workplaces, 
and businesses across the US. However, currently approved clinical testing options require 
reagents that are limited in supply and expensive qPCR machines, severely hindering scalability 
[4] coupled with acute shortage of person-power. In response to limited clinical testing options, 
rapid antigen tests that are available to purchase over-the-counter and can be self-administered 
have become recently a popular testing approach; however, these tests are expensive, in short 
supply, and may not be as sensitive in detecting Omicron variant compared to PCR tests [5]. 
Emerging evidence indicates that saliva testing with the option of self-administration of testing 
can accurately identify COVID-19 viral infection [6]. Moreover, this approach provides an 
option for the easy, safe and convenient collection of samples required for testing without 
traveling to a doctor’s office, hospital, or testing site. Point of care testing (i.e. using saliva-based 
self-collection to administer screening for COVID-19 in one’s own laboratory setting) utilizes 
testing equipment that is readily available to our workforce, leverages their existing training, and 
benefits from existing institutional health and safety infrastructure.  
Self-administration of saliva testing also reduces exposure of health care workers to the virus and 
preserves limited personal protective equipment [7]. Additional diagnostic testing options will 
continue to increase staff access and decrease resources needed from the health system to support 
testing. 
For these reasons, we propose to evaluate the implementation of a COVID-19 POC screening 
program that uses saliva-based self-testing and to pilot test approaches to improve program 
enrollment. 
5. Study design 
5.1 Design 
This is an implementation clinical trial that we anticipate lasting up to two months. In the first 
phase, we will pilot the approach with four PSOM laboratories. We plan to enroll up to 50 

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people across these labs during the pilot phase. Labs will be located either in the CRB, Smilow, 
or the BRB II/III buildings. We will pilot test the best manner to distribute saliva collection test 
kits and assay tests to participants and elicit rapid feedback for one week. We will apply 
feedback in real time to improve the distribution method. In the second phase, we will roll out 
the clinical trial more broadly across all interested PSOM laboratories. We anticipate enrolling 
up to 500 participants across all PSOM laboratories. All participants will be Penn employees 
(faculty, staff, and trainees) who work in a PSOM laboratory. 
 All participants will be required to provide informed consent and watch a training video before 
self-collecting their first saliva sample. All participants will be told they can collect saliva 
samples as much or as little as they want – but no more than daily for up to four weeks. They 
will also be asked to complete online surveys weekly for up to four weeks. These surveys are 
expected to take about 15 minutes to complete. See below for table of survey measures and 
frequency. A subset of participants will also be asked to participate in a one-time qualitative 
interview after the point of care testing program is over. This interview is expected to take about 
30 minutes.  
 
5.2 Study duration 
The study is expected to begin as soon as necessary approvals are obtained. Study participation 
in the point of care testing will last for up to four weeks. A subset of participants will be asked to 
participate in a qualitative interview after study participation is over. If they agree to participate, 
they will engage in a one-time interview with the research team which will last approximately 30 
minutes.  
 
5.3 Target population 
The target population is Penn faculty, staff, and trainees that work in person on campus at a 
PSOM laboratory.  
 
5.4 Accrual 
Up to 50 participants will be enrolled in the pilot phase. Up to 500 participants will be enrolled 
in the second phase.  
 
5.5 Key eligibility criteria 
To be eligible, participants must:  
 
1) Be 18 years or older 
2) Be University of Pennsylvania staff, faculty or trainee who is working in person on 
campus at a PSOM laboratory 
3) Have knowledge of safe practices in and access to a biological safety cabinet 
4) Have knowledge and access to pipet and PCR machine  
 

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6. Subject recruitment 
Penn Medicine leadership will email PIs of PSOM laboratories about this project and ask them to 
forward a recruitment email to the personnel who work in their laboratories. The recruitment 
email will include a link to a screening questionnaire in REDCap (a secure, web-based 
application for collecting and managing survey data that can be completed via computer or 
mobile device). All individuals who are interested in participating will click the link and answer 
the screening questions. The research team will collate interest and deliver saliva collection test 
kits and assay tests to a location in or close to each laboratory. The team will also share this 
location with potential participants, who will visit the location and scan a QR code. This QR 
code will direct them to REDCap, where they will be able to click a link to review the full 
consent.  If participants decide they want to participate, they will indicate this by checking a box 
and proceeding to the next page. If they do proceed, they will be considered enrolled in this 
study.  
7. Subject compensation 
Participants in the point of care testing portion of this study who complete surveys will be 
entered into a lottery to receive one of four $100 e-gift cards to Starbucks. Participants who 
engage in the qualitative interview will receive $25 e-gift cards to Starbucks.  
8. Study procedures 
 
8.1 Consent & HIPAA Authorization 
We have requested waiver of written documentation of consent from the Penn IRB. The 
required elements of informed consent and HIPAA Authorization for the study will be described 
in a consent form that participants can access via REDCap. If they agree to participate, 
participants will consent by checking a box and and proceeding to the second page. Only 
participants who click this box will be able to proceed to the next page. Additionally, only 
individuals who consented to the point of care testing program will be invited to participate in 
the qualitative interview. Before the interview is conducted, participants will be consented using 
a separate consent document that will be submitted to the IRB prior to use.  
During the consenting process, participants will have the opportunity to reach out to the research 
team with any questions the participant might have.  All potential participants will be asked to 
confirm that they understand the information provided, understand that participation is voluntary, 
and feel able to make an informed choice. All participants will be assured during the informed 
consent process that their decision to participate or not will not impact employment status at 
Penn.  
 
8.2 Procedures 

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Once participants provide consent in REDCap, they will be directed to a page that provides an 
instructional video on what to do next. Participants will be instructed to take a saliva collection 
test kit. When they are ready to self-collect their saliva sample, they will be instructed to not eat 
or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. 
Participants will then be instructed on how to inactivate the virus and bring their sample to their 
laboratory’s central PCR machine, where they will take an assay test. They will be instructed to 
collect saliva into a 1.5mL collection tube containing inactivation buffer (TCEP and EDTA) 
using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of 
saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat 
block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-
powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of 
the saliva sample safely and in accordance with best laboratory practices. No saliva samples will 
be collected by the research team at any time as part of this study.  
Each time a participant self-collects a saliva sample and runs the assay test, they will have the 
opportunity to pick up another saliva collection test kit. Each time they take another saliva 
collection test kit, they will scan a QR code (labeled for returning users) which will direct them 
to a simple REDCap prompting them for their name. We will use this data to record how many 
saliva collection kits are taken by each participant. Participants will be told they can do this point 
of care testing as frequently as they want (but no more than once a day for up to four weeks).  
Each week for up to four weeks, consented participants will also be emailed a link to the online 
REDCap survey. Based on the week of their participation, they will be asked a battery of survey 
measures (see below list of surveys along with survey frequency table). 
COVID SAFE 2.0 SURVEY MEASURES 
Measures  
Pre-
consent 
After training 
video and 
completing first 
test*  
Week 1 Week 2 
Week 
3 
Week 4 
Screening Questions 
X 
 
 
 
 
 
Use & POC testing 
 
X 
X 
X 
X 
X 
AIM, IAM, & FIM  
 
X 
 
X** 
 
X** 
Intervention Usability Scale 
(IUS) 
 
X 
 
 
 
X 
User Burden Scale (UBS) 
 
X 
 
 
 
X 
Participant Experience & 
Program Ease 
 
X 
 
X 
 
X 
Program Continuation & 
Availability 
 
X 
 
 
 
X 
Demographics 
 
X 
 
 
 
 

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*depending on what day of week participants consent to participate, these surveys will be collected at 
the Week 1 timepoint.  
**At Weeks 2 and 4, we will use a single item adapted version of AIM, IAM, FIM 
Survey Measures 
- 
Questions about participant’s use and results of test  
o Note, results of test are self report. No saliva samples will be collected as part of 
this study. If participants self-report a positive result, they will be asked to self-
report if they confirmed the positive result (i.e. by getting a CLIAA-approved 
test). Note, the confirmatory results are also self-report. No data will be entered 
into the EMR as part of this study.  
- 
The 4-item Acceptability of Intervention Measure (AIM); the 4-item Intervention 
Appropriateness Measure (IAM); and the 4-item Feasibility of Intervention Measure 
(FIM; Weiner et al., 2017). We will also use a modified 1-item version of each of these 
measures. See table of survey measures.  
- 
The Intervention Usability Scale (IUS) 
- 
The User Burden Scale (UBS) 
- 
Questions about the participant’s experience with point of care testing and program ease 
- 
Questions about program continuation and availability of testing to family members 
- 
Demographics questions 
During the pilot phase, we will check in with participants once to get real time feedback on 
changes to our test distribution method and rapidly adjust our workflow to refine our distribution 
method. During the second phase, we will scale up the program and make study enrollment 
available to all Penn faculty, trainees, and staff who work in person at a PSOM laboratory.  
Participants will be instructed to follow standard university and department specific guidelines 
for isolation and return to work if the assay is positive.  
The COVID-19 screening test was developed by University of Pennsylvania faculty and staff on 
the Rapid Assay Task Force. The task force was assembled under the direction of Dr. Jon 
Epstein, Chief Scientific Officer and Executive Vice Dean at the Perelman School of Medicine 
and is led by Dr. Arupa Ganguly, Professor, Department of Genetics. The assay is developed by 
Dr. Scott Sherrill-Mix, Department of Microbiology. The saliva-based test is conducted using a 
highly sensitive reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay 
compatible with reagents developed at the University of Pennsylvania to detect SARS-CoV-2 
viral RNA. LAMP is a method of isothermal DNA replication that utilizes DNA oligos that 
hybridize with different regions of the target molecule to form loops in the DNA. Utilizing a 
strand displacing polymerase, a fast amplification reaction can occur upon proper oligo binding 
to the desired target. Such reactions are capable of generating microgram quantitates of DNA in 
a very short period of time at a single reaction temperature. Furthermore, although the strand-

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displacing polymerase has reverse transcriptase activity, a reverse transcriptase can be included 
to improve sensitivity within the reaction when detecting an RNA target (RT-LAMP). The saliva 
test developed by the University of Pennsylvania uses SARS-CoV-2 specific primer sets along 
with molecular beacons, fluorescent reporter oligonucleotides designed to only fluoresce in the 
presence of amplified SARS-CoV-2 sequence. The protocol is simple, inexpensive, and rapid. 
Results are typically available in about one hour. Positive samples are called by comparison to 
positive and negative controls; reactions displaying a characteristic color under illumination by 
blue light and orange filtering indicate that the target sequence is present. Positive results are 
indicative of the presence of SARS-CoV-2-RNA but must be confirmed by a CLIA approved 
test. Our research suggest that assays based upon these protocols allow for a sensitivity down to 
about 20 genomes per microliter of saliva or further with increased reaction volume[8,9]. As an 
assay control, an additional primer set and molecular beacon targeting a common human mRNA 
and fluorescing in a different color will be included in reactions. 
Quality control (QC) checks will occur at multiple points in this protocol: 
1) Kit QC – Each batch of kits will be tested to ensure all components are functioning as 
expected.  
2) A positive control QC step, consisting of a LAMP reaction spiked with synthetic SARS-
CoV-2 RNA, will be included in each assay to validate LAMP function and provide a visual 
reference.  
3) A negative control QC step, consisting of LAMP reaction spiked with oligonucleotide 
matching the human control mRNA, will be included in each assay to ensure that no 
contamination of LAMP reagents has occurred and provide a visual reference. 
4) A primer set and molecular beacon targeting human mRNA will be included in each reaction 
to ensure that sample has been correctly added and no inhibition of the reaction has occurred.  
9. Analysis plan 
We will measure the primary outcomes of use, acceptability, appropriateness, and feasibility and 
the secondary outcomes of test results, program usability, user burden, participant experience, 
program ease, program continuation, and availability of testing to others using descriptive 
statistics. To evaluate the use of the program, we will evaluate the reported frequencies of self-
testing performed by participants. We will look at the relationship between these outcomes using 
regression. Qualitative analysis to achieve our additional secondary outcomes will be guided by 
an integrated approach, which provides a rigorous, systematic method to analyzing qualitative 
data and has been shown to produce robust theoretical models of social behavior in healthcare 
settings. This approach uses an inductive and deductive process of iterative coding to identify 
recurrent themes, categories, and relationships in qualitative data. A comprehensive coding 
scheme to produce a fine-grained descriptive analysis of the role of multilevel contextual 
characteristics on implementation. Using Nvivo, we will then separately code a sample of 

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transcripts and compare their application of the coding scheme to assess reliability and 
robustness. Disagreements will be resolved through discussion.  
10. Investigative Team 
• Rinad Beidas, PhD, Professor, Psychiatry, Medical Ethics and Health Policy, and 
Medicine, Perelman School of Medicine, rinad.beidas@pennmedicine.upenn.edu  
• Arupa Ganguly, PhD, Professor of Genetics at the Hospital of the University of 
Pennsylvania, ganguly@mail.med.upenn.edu  
• Scott Sherrill-Mix, PhD, Postdoctoral Researcher, shescott@pennmedicine.upenn.edu.   
11. Human research protection 
 
11.1 Data confidentiality 
Computer-based files will only be made available to personnel involved in the study through the 
use of access privileges and passwords. Wherever feasible, identifiers will be removed from 
study-related information. Lab staff may be privy to participant identity in that they will see 
participants pick up test kits but have been trained to maintain confidentiality. Precautions are in 
place to ensure the data are secure by using passwords and encryption, because the research 
involves web-based surveys.  
 
11.2 Subject confidentiality 
Research data will be obtained from participant surveys and interviews.  All participants will 
provide informed consent prior to study participation. Research data that is obtained will be used 
for research purposes only. Patient identifiers will be used only for linkage purposes or to contact 
patients. The study identification number, and no other identifying information, will be used on 
all data collection instruments. All study staff will be reminded to appreciate the confidential 
nature of the data collected and contained in these databases. The Penn Medicine Academic 
Computing Services (PMACS) will be the hub for the hardware and database infrastructure that 
will support the project and is where the REDCap portal is based. The PMACS is a joint effort of 
the University of Pennsylvania's Abramson Cancer Center, the Cardiovascular Institute, the 
Department of Pathology, and the Leonard Davis Institute. The PMACS provides a secure 
computing environment for a large volume of highly sensitive data, including clinical, genetic, 
socioeconomic, and financial information. Among the IT projects currently managed by PMACS 
are: (1) the capture and organization of complex, longitudinal clinical data via web and clinical 
applications portals from cancer patients enrolled in clinical trials; (2) the integration of genetic 
array databases and clinical data obtained from patients with cardiovascular disease; (3) 
computational biology and cytometry database management and analyses; (4) economic and 
health policy research using Medicare claims from over 40 million Medicare beneficiaries. 
PMACS requires all users of data or applications on PMACS servers to complete a PMACS-
hosted cybersecurity awareness course annually, which stresses federal data security policies 

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under data use agreements with the university. The curriculum includes Health Insurance 
Portability and Accountability Act (HIPAA) training and covers secure data transfer, passwords, 
computer security habits and knowledge of what constitutes misuse or inappropriate use of the 
server. We will implement multiple, redundant protective measures to guarantee the privacy and 
security of the participant data. All investigators and research staff with direct access to the 
identifiable data will be required to undergo annual responsible conduct of research, 
cybersecurity, and HIPAA certification in accordance with University of Pennsylvania 
regulations.  
Data will be stored, managed, and analyzed on a secure, encrypted server maintained by Penn 
Medicine Nudge Unit and/or the Penn Center for Mental Health. All study personnel that will 
use this data are listed on the IRB application and have completed training in HIPAA standards 
and the CITI human subjects research. Data access will be password protected. Whenever 
possible, data will be de-identified for analysis. 
 
 
11.3 Subject privacy 
Interested participants will be directed to the REDCap platform where they will be asked to enter 
data related to eligibility. Participants can choose when and where to access this platform, 
maintaining their own privacy.  There is the possibility that a participant’s involvement in the 
study may be made known to other participants, as other study participants may be visiting the 
central lab location at the same time to pick up saliva sample collection kits. Other study 
participants will not have access to any personal information or other information collected 
throughout this study. All efforts will be made by study staff to ensure subject privacy. 
 
11.4 Data disclosure 
The following entities, besides the members of the research team, may receive protected health 
information (PHI) for this research study. The Office of Human Research Protections at the 
University of Pennsylvania -Federal and state agencies (for example, the Department of Health 
and Human Services, the National Institutes of Health, and/or the Office for Human Research 
Protections), or other domestic or foreign government bodies if required by law and/or necessary 
for oversight purposes. 
 
11.5 Data safety and monitoring 
The Principal Investigators and research team will closely monitor the safety, privacy, and data 
integrity of the study. Patients will be provided contact information for study staff and if adverse 
events are identified, events will be reported and brought to the PI’s attention.  
 
 
11.6 Risk/benefit  

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11.6.1 Potential study risks 
All data described previously will be protected as described in the Subject confidentiality 
section. There is minimal risk to subjects as there is minimal risk of breach of data. Our team has 
extensive experience working with these types of data. We will use commercial-grade encryption 
to protect participant information. Their personal information will only be used by study team 
members who have been trained to use secure protocols to maintain the privacy of data.  Risks 
and side effects related to this study include the possibility that answering certain questions on 
the surveys about symptoms may make study participants feel slightly uncomfortable or may be 
inconvenient. The risks of self-collecting a saliva sample for testing may include the possibility 
for false positives or false negatives, testing may induce feelings of fear or anxiety, a positive test 
result may cause participants to miss days of work, and individuals may experience mild 
discomfort if they receive the CLIA approved test. We expect the risks of picking up and 
dropping of test kits to be no more than the risk of returning to campus. 
 
 
 
11.6.2 Potential study benefits 
This unique program could improve the health of individuals by picking up on changes in 
symptoms earlier allowing individuals with COVID-19 to be identified quickly and reduce the 
spread of the virus. However, participants may receive no benefit from the study. 
 
 
11.6.3 Risk/benefit assessment 
There is minimal risk of breach of data and appropriate measures have been taken. Therefore, we 
believe the risk/benefit assessment is favorable given the potential insights that could be yielded 
from the findings of this study.   
12. References 
1. Stokes EK, Zambrano LD, Anderson KN, et al. Coronavirus Disease 2019 Case 
Surveillance—United States, January 22 – May 30, 2020. MMWR Morb Moral Wkly Rep 
2020;69:759-765.  
2. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real 
time. Lancet Infect Dis; published online Feb 19.  
3. McClellan M, Gottlieb S, Mostashari F, et al. A national COVID-19 surveillance system: 
Achieving containment. Accessed June 29, 2020. 
https://healthpolicy.duke.edu/sites/default/files/atoms/files/covid-
19_surveillance_roadmap_final.pdf 
4. Association of State and Territorial Health Officials, Association of Public Health 
Laboratories, and Council of State and Territorial Epidemiologists. COVID-19 Testing 
Needs to Be Limited to Priority Groups Unit Sufficient Testing Supplies and Personal 
Protective Equipment is Available Nationwide. Accessed June 29, 2020. 

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https://www.astho.org/Press-Room/COVID-19-Testing-Needs-to-Be-Limited-to-Priority-
Groups-for-Now/03-20-20/ 
5. Ferré VM, Peiffer-Smadja N, Visseaux B, Descamps D, Ghosn J, Charpentier C. Omicron 
SARS-CoV-2 variant: What we know and what we don't [published online ahead of print, 
2021 Dec 10]. Anaesth Crit Care Pain Med. 2021;41(1):100998. 
doi:10.1016/j.accpm.2021.100998 
6. U.S. Food & Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes First 
Diagnostic Test Using At-Home Collection of Saliva Specimens. Accessed June 29, 2020. 
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
authorizes-first-diagnostic-test-using-home-collection-saliva 
7. Tu YP, Jennings R, Cangelosi GA, et al. Swabs collected by patients or health care workers 
for SARS-CoV-2 Testing. N Engl J Med. 2020. PMID: 32492294. 
8. Rabe BA, Cepko C. SARS-CoV-2 detection using an isothermal amplification reaction and a 
rapid, inexpensive protocol for sample inactivation and purification. medRxiv preprint doi: 
https://doi.org/10.1101/2020.04.23.20076877. Accessed July 7, 2020. 
9. Sherrill-Mix S, Hwang Y, Roche AM, et al. Detection of SARS-Co-V-2 RNA using RT-
LAMP and molecular beacons. Genome Biol 22, 169 (2021). https://doi.org/10.1186/s13059-
021-02387-y