An interventional study of SPOTFIRE ST System in Pharyngitis, Infective, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Diagnostic
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. Up to 200 participants will be on study for up to approximately 25 minutes.
The broader 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 (preparatory for the clinical trial, included here for context only).
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.
AIMS 2-3 are registered to this ClinicalTrials.gov record.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 200 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Illness onset in the last 7 days, AND:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 provider survey, presenting at the Urgent Care facilities, will be enrolled.
Device: SPOTFIRE ST System
Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
Also known as: SPOTFIRE ST
Aim 2 Clinical Outcome: Summary of Test Results
SPOTFIRE ST results by count.
Time frame: up to 20 minutes
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit. Treatable Pathogens include: Influenza A or B (FluA/B), Group A Strep (GAS), Mycoplasma pneumoniae (Mpn), Chlamydia pneumoniae (Cpn)
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 3: Participant Satisfaction Survey
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to approximately 4 months)
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Utility Survey
Providers will be surveyed to learn how they might use the SPOTFIRE test in the future. Survey responses will be ranked and reported by response rate. Providers were asked to rank each patient population from 1-7, a nominal point value was given for this ranking to generate the scores (rank of 1=1, rank of 2=2, etc.) Lower scores indicate higher (more important) ranking. Mean rank score for each patient population is reported here to give the reader an idea of how important each item was for the group of providers.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often Test Used?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience. Prescription for Antibiotics or Antivirals (Rx Abx/AV)
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Participants were consented and enrolled from December 2024 to March 2025. Providers were not formally consented, their survey response was voluntary. Provider participation was preparatory to research only and was deemed Program Evaluation pursuant to 45 Code of Federal Regulations (CFR) 46.
| Milestone | Eligible SPOTFIRE ST Participants |
|---|---|
| Started | 200 |
| Completed | 200 |
| Not completed | 0 |
SPOTFIRE ST results by count.
| Participants | Adult Detections | Pediatric Detections |
|---|---|---|
| Adenovirus | 1 | 6 |
| Seasonal Coronavirus | 14 | 13 |
| Human Metapneumovirus | 2 | 2 |
| Rhino/Enterovirus | 7 | 21 |
| Influenza A | 14 | 29 |
| Influenza B | 1 | 9 |
| Parainfluenza | 1 | 5 |
| RSV | 6 | 11 |
| Group A Strep | 9 | 36 |
| Group C/G Strep | 2 | 1 |
| C. pneumoniae | 0 | 3 |
| M. pneumoniae | 1 | 14 |
| Negative Test | 33 | 18 |
| More than one pathogen | 6 | 44 |
Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Rapid Flu test | 16 |
| Rapid RSV test | 16 |
| COVID PCR test | 21 |
| Rapid Strep Antigen test | 40 |
Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Positive Rapid Flu Test | Negative Rapid Flu Test |
|---|---|---|
| Positive SPOTFIRE test | 3 | 0 |
| Negative SPOTFIRE test | 0 | 13 |
Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Positive Rapid RSV Test | Negative Rapid RSV Test |
|---|---|---|
| Positive SPOTFIRE test | 2 | 0 |
| Negative SPOTFIRE test | 0 | 14 |
Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Positive COVID PCR Test | Negative COVID PCR Test |
|---|---|---|
| Positive SPOTIFRE test | 0 | 12 |
| Negative SPOTIFRE test | 3 | 6 |
Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Positive Rapid Strep Antigen Test | Negative Rapid Strep Antigen Test |
|---|---|---|
| Positive SPOTFIRE test | 9 | 3 |
| Negative SPOTFIRE test | 0 | 28 |
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit. Treatable Pathogens include: Influenza A or B (FluA/B), Group A Strep (GAS), Mycoplasma pneumoniae (Mpn), Chlamydia pneumoniae (Cpn)
| Participants | Adult Detections | Pediatric Detections |
|---|---|---|
| Treatable (FluA/B, GAS, Mpn, Cpn) | 23 | 80 |
| Influenza detected and prescribed antiviral | 6 | 11 |
| Treatable bacterial pathogen detection and prescribed antibiotic (GAS, Mpn, Cpn) | 9 | 49 |
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.
| Participants | Adult Detections | Pediatric Detections |
|---|---|---|
| Patients without treatable bacterial detection prescribed an antibiotic | 10 | 10 |
| SPOTFIRE negative | 7 | 6 |
| SPOTFIRE single virus | 2 | 2 |
| SPOTFIRE multiple viruses | 0 | 2 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Completed Survey | 186 |
| Swab Acceptable | 177 |
| Took Test before Visit | 138 |
| Liked Testing before Visit | 121 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Relieved | 74 |
| Relieved | 82 |
| Fairly Relieved | 20 |
| Slightly Relieved | 7 |
| Not Relieved | 3 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Satisfied | 104 |
| Satisfied | 67 |
| Fairly Satisfied | 9 |
| Slightly Satisfied | 3 |
| Not Satisfied | 2 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Satisfied | 103 |
| Satisfied | 62 |
| Fairly Satisfied | 14 |
| Slightly Satisfied | 7 |
| Not Satisfied | 0 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Satisfied | 90 |
| Satisfied | 72 |
| Fairly Satisfied | 11 |
| Slightly Satisfied | 8 |
| Not Satisfied | 5 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Useful | 128 |
| Useful | 38 |
| Fairly useful | 12 |
| Slightly Useful | 3 |
| Not Useful | 5 |
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
| Participants | Eligible SPOTFIRE ST Participants |
|---|---|
| Very Likely | 132 |
| Likely | 41 |
| Fairly Likely | 7 |
| Slightly Likely | 4 |
| Not Likely | 1 |
Providers will be surveyed to learn how they might use the SPOTFIRE test in the future. Survey responses will be ranked and reported by response rate. Providers were asked to rank each patient population from 1-7, a nominal point value was given for this ranking to generate the scores (rank of 1=1, rank of 2=2, etc.) Lower scores indicate higher (more important) ranking. Mean rank score for each patient population is reported here to give the reader an idea of how important each item was for the group of providers.
| rank order score | Provider Survey Pre SPOTFIRE | Provider Survey Post SPOTFIRE |
|---|---|---|
| Patients over the age of 65 years with acute pharyngitis symptoms | 5.51 | 5.50 |
| Adults aged 18-64 years with acute pharyngitis symptoms | 4.69 | 5.09 |
| Preschool and school aged children (3-17 years) with acute pharyngitis symptoms | 2.46 | 2.63 |
| Toddlers (1-2 years) with febrile illness (may or may not be able to report pharyngitis symptoms) | 3.59 | 3.38 |
| Infants (less than 12 months) with acute febrile illness | 4.38 | 3.91 |
| Patients with chronic medical comorbidities with acute pharyngitis symptoms | 4.13 | 4.13 |
| Patient with immunocompromising conditions or medications with acute pharyngitis symptoms | 3.24 | 3.38 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Often | 5 |
| Sometimes | 13 |
| Rarely | 15 |
| Never | 23 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Very Easy | 20 |
| Easy | 7 |
| Neutral | 6 |
| Difficult | 0 |
| Very Difficult | 0 |
A separate analysis looking at pathogen detections for viral and bacterial pathogens was performed.
| Participants | Adult Detections | Pediatric Detections |
|---|---|---|
| Positive for single virus | 37 | 34 |
| Positive for multiple viruses | 1 | 14 |
| Positive for single bacteria | 7 | 21 |
| Positive for multiple bacteria | 0 | 1 |
| Positive for virus and bacterial pathogens | 5 | 29 |
| Nothing detected | 33 | 18 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Very Prepared | 8 |
| Prepared | 13 |
| Neutral | 9 |
| Slightly Prepared | 2 |
| Not Prepared | 1 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Often | 2 |
| Sometimes | 10 |
| Rarely | 11 |
| Never | 9 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Extremely Useful | 13 |
| Very Useful | 11 |
| Moderately Useful | 4 |
| Slightly Useful | 3 |
| Not Useful | 2 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Extremely Useful | 13 |
| Very Useful | 11 |
| Moderately Useful | 6 |
| Slightly Useful | 2 |
| Not Useful | 1 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience. Prescription for Antibiotics or Antivirals (Rx Abx/AV)
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Always | 6 |
| Often | 8 |
| Sometimes | 8 |
| Rarely | 8 |
| Never | 3 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Always | 6 |
| Often | 20 |
| Sometimes | 5 |
| Rarely | 2 |
| Never | 0 |
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
| Participants | Provider Survey Post SPOTFIRE |
|---|---|
| Before Visit | 27 |
| During Visit | 6 |
| After Visit | 0 |
Collected over up to 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eligible SPOTFIRE ST Participants | 0/200 (0%) | 0/200 (0%) | 0/200 (0%) |
| Age, Continuous(years) | Eligible SPOTFIRE ST Participants |
|---|---|
| Mean | 24.8 (1 to 85) |
| Sex/Gender, Customized(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| Female | 111 |
| Male | 86 |
| Non-Binary | 2 |
| Prefer Not to Answer | 1 |
| Race (NIH/OMB)(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 13 |
| Black or African American | 3 |
| White | 152 |
| More than one race | 15 |
| Unknown or Not Reported | 7 |
| Race/Ethnicity, Customized(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 19 |
| Black or African American | 17 |
| Native Hawaiian or Pacific Islander | 4 |
| White / Caucasian | 167 |
| Prefer not to answer | 4 |
| Region of Enrollment(participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| United States | 200 |
| Age Group(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| Pediatric | 117 |
| Adult | 83 |
| Recruitment Group(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| Ages 12-35 months with fever | 7 |
| Ages 3-17 years with sore throat | 110 |
| Any age with immunocompromising conditions or is on immunocompromising medications with sore throat | 20 |
| Any age with comorbidities (ie. respiratory, cardiovascular, metabolic, renal) with sore throat | 98 |
| Attend School(Participants) | Eligible SPOTFIRE ST Participants |
|---|---|
| In Person | 106 |
| Home or Virtual | 4 |
| No | 90 |
9 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison →