SPOTFIRE ST TITUS STUDY: Provider Identified Target Populations, Implementation, Test Performance, Potential Utility, and Satisfaction of SPOTFIRE ST in the Urgent Care
Phase: NA
Conditions: Pharyngitis, Infective
Sponsor: University of Wisconsin, Madison

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SPOTFIRE Sore Throat (ST) Study 
 
NCT06713642 
 
June 20, 2024 
 
 

PROTOCOL TITLE: 
SPOTFIRE ST TITUS STUDY: Provider identified Target populations, Implementation, 
Test performance, potential Utility, and Satisfaction of SPOTFIRE ST in the Urgent Care 
LEAD RESEARCHER: 
Dr. Alexander Lepak 
SMPH/Medicine/Infectious Disease 
608-263-1545 
ajlepak@medicine.wisc.edu 
Co-Investigators 
Dr. Jonathan Temte 
SMPH/Family Medicine 
608-263-3111 
jon.temte@fammed.wisc.edu 
 
VERSION NUMBER/DATE: 
Protocol Number: 
BFD-RST-23-010 
Protocol Date: 
 
June 20, 2024 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
NOTE: Leave this section blank for the initial submission. The revision history should be 
documented for modifications to approved studies. 

TABLE of 
CONTENTS 
 
 
 
Section 
Title 
Page 
I 
Purpose 
3 
II 
Study Design 
3 
III 
Interactions with Subject during pharyngeal swab 
4 
IV 
Materials 
5 
V 
Clinical Study Subjects 
6 
VI 
Patient Demographics and Medical History 
6 
VII 
Test Procedures 
7 
VIII 
Clinical Study Locations 
7 
IX 
Study Duration 
8 
X 
Risk and Precautions 
8 
XI 
Data Analysis 
8 
XII 
Adverse Events 
9 
XIII 
Principal Investigator Responsibilities 
9 
XIV 
Administrative Aspects 
10 
XV 
References 
11 

I. 
PURPOSE 
 
The purpose of this study is to evaluate where urgent care (UC) clinicians see 
the most benefit for a novel, point of care pharyngitis test, SPOTFIRE ST, and 
describe its performance, potential clinical utility, and satisfaction of providers 
and patients with this novel test. The study is separated into three specific aims. 
AIM 1. Evaluate which specific patient populations UC providers see the most 
need and benefit from SPOTFIRE ST, a multiplex point of care pharyngitis test. 
AIM 2. Evaluate the performance and effects of test results associated with 
important clinical outcomes (e.g., prescriptions, additional testing, disposition 
and follow-up) for patients in the top 3-4 high-risk subpopulations identified by 
providers in Specific AIM 1. 
AIM 3. Evaluate patient and provider satisfaction and future use opportunities of 
the SPOTFIRE ST Panel testing platform in the clinical pathway for evaluating 
patients with pharyngitis in UC centers. 
 
 
II. 
STUDY DESIGN 
 
AIM 1: Query UC providers prior to SPOTFIRE ST implementation. 
UC providers at UW Health will be sent an electronic survey. The survey will aim 
to understand two important aspects of the current needs/wants of UC providers 
regarding the evaluation of patients with pharyngitis. First, providers will be 
asked to rank order patient groups they would most likely want and use a rapid 
pharyngitis test that would provide bacterial and viral pathogen targets. Second, 
providers will be asked to rank order aspects or factors that drive them to order 
a rapid group A strep throat swab for patients presenting to UC with pharyngitis. 
Additional demographic information about the providers will also be collected. 
 
AIM 2: Implement SPOTFIRE ST Panel into an urgent care setting. 
This study will utilize one urgent care facility, from which individual patients will 
be recruited to participate. The study period will occur during a 3-month period 
of elevated upper respiratory infection (URI) virus circulation (likely occurring 
between November 2024 to February 2025) as defined by local surveillance 
data. Recruitment will be conducted after patients have registered to be seen by 
Urgent Care providers and while waiting to receive services. Patients presenting 
with acute pharyngitis and are of the high-risk groups will be eligible to 
participate. 
 
Some of the high-risk groups are age-based and their eligibility to participate can 
be determined upon check-in. Other high-risk groups are determined by their 

comorbidities and immunocompromising conditions; therefore, study staff may 
have to screen in the waiting room or wait until the patient is roomed by a nurse 
or seen by the provider to determine eligibility. 
 
Research staff/coordinators that have been highly trained to run testing on the 
SPOTFIRE ST and in the proper collection of pharyngeal swabs will be stationed 
at the urgent care site. Staff will be selected and trained by the Principal 
Investigator and Biomérieux trainers. 
The pharyngeal swab will be tested immediately in the SPOTFIRE ST System 
by the research coordinator 
When finished with the subject, the coordinator will return them to their Urgent 
Care appointment and deliver the test result upon test completion. 
 
A maximum of 200 patients, representing the top 3-4 patient groups that were 
identified as benefitting most from a SPOTFIRE ST test through the survey, 
presenting at the Urgent Care facilities, will be enrolled. 
 
Pharyngeal specimens will be obtained from each subject after informed consent 
is obtained from each subject or subject’s parent(s) or guardian in writing. The 
study will be conducted in accordance with the Health Insurance Portability and 
Accountability Act (HIPAA). The patients will receive a token compensation of 
$25 for their participation. 
 
The patient, parent or guardian will be asked to complete a questionnaire 
requesting demographic and historical health data. 
 
The patient/clinician will receive results. The clinician will be responsible for 
recording the result in the medical record as the Research Coordinators will have 
“view only” access of the medical record. 
 
AIM 3: Query UC providers and patients after SPOTFIRE ST use. 
UC providers and patients who utilize SPOTFIRE testing will be sent an 
electronic or paper survey. The survey will evaluate patient and provider 
satisfaction with the SPOTFIRE ST testing pathway and evaluate how the 
platform may be used in the future by UC clinicians. 
 
 
III. INTERACTIONS WITH SUBJECT DURING PHARYENGEAL SWAB 
 
The Principal Investigator will ensure that the research staff at the UWHealth Urgent 
Care Centers (UWHUCC) supporting the study adhere to the following steps carefully. 
1. This study will be done on an individual basis. Only one patient 
or parent/guardian and child will participate in the study at a time. 
2. After informed consent is completed, the subject will be asked patient 

demographic and medical history questions. (Listed in section VI) 
3. Study personnel will collect the pharyngeal swab. 
4. The subject will be returned to their Urgent Care appointment and their 
swab will be tested on the SPOTFIRE ST. 
5. Study personnel will deliver the test result to the subject and provide a paper 
post- study survey or schedule the post-study survey to be delivered 
electronically. 
6. Participant comments will be analyzed at least one time during the course 
of the study. However, more frequent analyses may be necessary, based on 
the recommendation of the Principal Investigator and/or the clinical 
coordinator the UWH UCC site. 
7. Study personnel will maintain a checklist to ensure that the 
demographic and medical history questionnaire and survey are 
completed. 
8. One or two face-to-face meetings between the Principal Investigator, his 
staff, and Biomérieux personnel will likely be required after one month, after 
two months, and at completion of the study. Study duration will likely be four 
full months. Additional meetings might be needed face-to-face or by 
conference call at the request of the Principal Investigator or Biomérieux. 
IV. 
MATERIALS 
Materials Provided 
The following materials (Table 1) will be provided to each site. 
 
Table 1 
Provided Materials 
Item 
Source/Vendor 
Number 
Spotfire Control System 
Biomérieux 
1 
Spotfire modules 
Biomérieux 
2 
Spotfire r/ST kits 
Biomérieux 
270 
Pharyngeal swabs 
Biomérieux 
300 
Verification and QC materials 
Biomérieux 
As required 
Materials Not Provided 
The following materials (Table 2) will not be provided by Biomérieux. 
 
Table 2 

Materials Not Provided 
Item 
Source/Vendor 
Number 
PPE (masks, hand sanitizer, etc.) 
Research team will 
purchase with study 
funds allocated to 
supplies 
 
V. CLINICAL STUDY SUBJECTS 
 
Inclusion Criteria 
AIM 1: All UC providers who are credentialled and work at UW Urgent Care center 
will get a survey. 
AIM 2: Any patient with an acute pharyngitis and conforms to one or more of the 
3-4 high-risk groups that were identified by UC providers in AIM 1 will be invited to 
participate when research staff is present. Up to a total of 200 participants. 
AIM 3: All UC providers and patients who participated in AIM 2 will receive a post-
study survey. 
 
Exclusion Criteria: 
AIM 2: 
(1) Anatomic anomalies that would prohibit safely collecting a pharyngeal swab 
specimen 
(2) Symptom onset more than 7 days prior to arrival at urgent care 
(3) Patient is already on an antiviral medication or an antibiotic medication 
(4) Previous participation in the study 
(5) Unable to read and understand or refusal to sign the appropriate informed 
consent/assent forms 
(6) Refusal to provide their demographics, household information 
 
 
VI. PATIENT DEMOGRAPHICS AND MEDICAL HISTORY 
Upon patient consent, the attending study personnel will collect basic 
demographic and medical history information for each enrolled patient. The 
Principal Investigator will work with the study personnel to ensure that this 
information is linked to the patient’s SPOTFIRE test results. 
 
The following information will be collected but may change slightly prior to 
publishing the final forms for the study. Should any forms or materials be revised, 
they will be submitted to Advarra for IRB approval. 

Demographics: 
- 
Age 
- 
Sex 
- 
Race 
- 
Ethnicity (Hispanic/non-Hispanic) 
- 
Highest level of education 
- 
Job Title/Occupation 
 
Medical Background: 
- 
Current Symptoms (checklist) 
- 
Severity of Illness 
- 
Days Since Onset of Symptoms 
- 
Measured temperature 
- 
Pregnancy (Y/N) 
- 
Any Chronic Medical Problem (Y/N) 
- 
Tobacco Use 
(Y/N) 
- 
Routine Prescription Medications 
(Y/N) 
- 
Influenza Vaccination for current year (Y/N) 
- 
Ever receive a Covid Vaccination? (Y/N) 
- 
Received a Covid Vaccination in the last 12 months? (Y/N) 
 
Post Visit Data (based post-visit on medical chart review) 
 
- 
Respiratory Infection Diagnosis for this Episode 
- 
Visit test results (Flu, RSV, COVID-19, Rapid strep, strep culture) 
- 
SPOTFIRE ST result 
- 
Flu/Covid vaccine verification 
- 
Antiviral Prescribed 
- 
Antibiotic Prescribed 
- 
Laboratory Testing Ordered (Blood culture, CBC, C-reactive protein, 
procalcitonin, respiratory virus PCR, urinalysis, urine culture, mono spot, 
other) 
- 
Imaging Studies 
- 
Chest X-ray 
- 
Disposition 
- 
Visit duration 
- 
3-week follow up disposition 
 
VII. TEST PROCEDURES 
SPOTFIRE ST 
The SPOTFIRE ST Analyzers for this study will be used in compliance with the 
SPOTFIRE ST Analyzer’s User Manual. The SPOTFIRE ST will be performed in 

accordance with the FDA-cleared package insert instructions for pharyngeal 
swab specimens. The package insert is attached hereto. 
 
 
VIII. CLINICAL STUDY LOCATIONS 
This study will be conducted at one UW Health Urgent Care Centers 
(UWHUCC). The Principal Investigator will negotiate with the UWHUCC to 
determine availability, costs, and use of facilities therein for conduct of the 
proposed study. The locations of the testing sites are shown in Table 3. 
 
Table 3 Study Location 
 
Site 
Name 
Location 
Address 
UWHUCC West 
Madison, WI 
7102 Mineral Point Rd, Madison, WI 53717 
 
 
IX. 
STUDY DURATION 
 
AIM 1: October – The pre study surveys will be emailed to clinicians. Later this 
month we will analyze the results to identify target populations for enrollment in 
AIM 2: November- February - The proposed study will span the influenza season 
and last approximately four months. Most likely the study will cover the 2024 to 
2025 winter upper respiratory infection virus season. The study will likely extend 
from early November to February 2025. This period is the most common time 
during which a season’s epidemic begins and ends in Wisconsin, but the period 
of study will be dependent on the evolution of the viral URI season this coming 
fall and winter. 
AIM 3: Participant post-study surveys will be sent out shortly after the UC 
appointment. Clinician post-study surveys will be sent out after AIM 2 is complete 
in February. 
 
X. RISKS AND PRECAUTIONS 
All specimens obtained from the enrolled subject patients are potentially 
infectious. Proper care in obtaining and handling of specimens must follow 
Universal Safety Precautions and standard/institution biohazard procedures for 
all discarded materials. 
All study personnel will have received seasonal influenza and COVID-19 
vaccines at least 14 days prior to the start of the study. 

XI. DATA ANALYSIS 
 
After the completion of the study, all observations and comments provided by 
the study personnel and participants will be entered into a master spread 
sheet/database for analysis. 
Possible correlations with patient age, time after onset of illness, underlying 
demographics and medical history, as well as with user comments regarding 
swab collection itself will also be analyzed. 
 
XII. ADVERSE EVENTS 
All adverse events and complications related to the study procedures must be 
reported verbally by the Principal Investigator to the Clinical Research Associate 
at Biomérieux, or its designated representative, within twenty-four (24) hours and 
in writing within five (5) days of the observation of the adverse event. This 
information should include the date of onset, a complete description of the event, 
including severity, duration, action taken and outcome (See Appendix IX- entitled 
“Adverse Event Report” for further details). 
 
XIII. PRINCIPAL INVESTIGATOR RESPONSIBILITIES 
A. Recording of Data 
Clinical Study Case Report Forms (CRFs), User Surveys, and Patient 
Information Sheets will be supplied by Biomérieux. Completed forms will be 
made available by the Principal Investigator and a copy provided to Biomérieux. 
The Principal investigator will ensure that the forms are properly generated for 
each patient enrolled and are legible and maintained securely. 
B. Record Retention 
Copies of all pertinent study related information will be securely stored and 
retained by the Principal Investigator for a minimum period of two years following 
the completion of the study. 
C. Confidentiality 
The Principal Investigator will be responsible for retaining information about 
study test results so that Biomérieux or a regulatory agency may access this 
information, if needed and required by law. All study records provided to 
Biomérieux will have no subject identification that will link the identification of the 
subject to the study records. A unique non-identifying study ID number will be 
used on all study related records without the use of any personal information. All 

study records should be retained in a confidential manner for a minimum of two 
years (or longer, if required by sponsor). 
Research records may be inspected and or copied for research or regulatory 
purposes by Biomérieux or regulatory agencies as required by law. There will be 
no personal subject identifiers on any copied study data to link subject identity. 
Results of this research study may be presented at meetings or in publications; 
however, there will be no subject identification used and therefore no possibility of 
disclosure of subject identity will be possible. 
D. Subject Consent to Participate 
Prior to any procedure being performed, the subject will be informed about the 
device, and will be given information about the intended purpose, possible 
benefits, and possible adverse events associated with the study. The procedure 
and possible hazards to which the subject will be exposed will be explained. An 
approved informed consent statement will then be read and signed by the 
subject/parent or legal guardian, and the Principal Investigator or trained 
designee. The subject/parent or guardian will be provided with a copy of the 
signed consent to participate statement. Verification of a signed consent to 
participate statement will be noted on the subject’s report forms. The Principal 
Investigator will provide Biomérieux with an unsigned copy of the consent to 
participate statement prior to and following approval by his internal Ethics 
Committee/Institutional Review Board. 
E. Ethics Committee/Institutional Review Board 
The final approved protocol and the consent to participate statement to be 
administered must first be approved by a properly constituted Ethics Committee 
(EC) or Institutional Review Board (IRB). Ethics Committees/Institutional Review 
Boards in the U.S. must adhere to the Food and Drug Administration Regulations 
(21 CFR, Part 56). Written approval from the EC/IRB must be forwarded to 
Biomérieux Corporation before clinical supplies will be shipped. 
 
XIV. ADMINISTRATIVE ASPECTS 
 
A. Modification of the Protocol 
Any changes to the protocol that affect study objectives, study design, subject 
population, study procedures, or significant administrative aspects will require 
written approval by both parties prior to the implementation of changes. It is the 
obligation of Biomérieux and the Principal Investigator to determine if a new 
EC/IRB submission is required prior to the implementation of any amendment to 
the protocol. If it is required, the amendment cannot be implemented until written 
approval is obtained from the EC/IRB. 

B. Publication of Research Findings 
The Principal Investigator is required to provide Biomérieux with complete test 
results and records for all data developed in this study. Biomérieux is responsible 
for all submissions to regulatory agencies, e.g. FDA. Biomérieux retains the right 
to review all publications, including full-length articles, abstracts, posters and 
presentations, for content prior to submission or delivery. This review is only to 
ensure accuracy and non-disclosure of information deemed proprietary to 
Biomérieux and does not deny the investigator the right to publish. 
 
 
 
XV 
REFERENCES