Trial Outcomes & Findings for SPOTFIRE Sore Throat (ST) Study (NCT NCT06713642)
NCT ID: NCT06713642
Last Updated: 2026-03-23
Results Overview
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Results posted on
2026-03-23
Participant Flow
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.
371 participants were screened for enrollment into the study, 232 were found eligible, and 200 enrolled. Most participants declined enrollment because they were not interested or feeling too sick to participate.
Participant milestones
| Measure |
Eligible SPOTFIRE ST Participants
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.
SPOTFIRE ST System: Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SPOTFIRE Sore Throat (ST) Study
Baseline characteristics by cohort
| Measure |
Eligible SPOTFIRE ST Participants
n=200 Participants
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.
SPOTFIRE ST System: Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
|
|---|---|
|
Age, Continuous
|
24.8 years
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
111 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
2 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Prefer Not to Answer
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
167 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=10 Participants
|
|
Age Group
Pediatric
|
117 Participants
n=10 Participants
|
|
Age Group
Adult
|
83 Participants
n=10 Participants
|
|
Recruitment Group
Ages 12-35 months with fever
|
7 Participants
n=10 Participants
|
|
Recruitment Group
Ages 3-17 years with sore throat
|
110 Participants
n=10 Participants
|
|
Recruitment Group
Any age with immunocompromising conditions or is on immunocompromising medications with sore throat
|
20 Participants
n=10 Participants
|
|
Recruitment Group
Any age with comorbidities (ie. respiratory, cardiovascular, metabolic, renal) with sore throat
|
98 Participants
n=10 Participants
|
|
Attend School
In Person
|
106 Participants
n=10 Participants
|
|
Attend School
Home or Virtual
|
4 Participants
n=10 Participants
|
|
Attend School
No
|
90 Participants
n=10 Participants
|
|
Attend Daycare
Yes
|
23 Participants
n=10 Participants
|
|
Attend Daycare
No
|
173 Participants
n=10 Participants
|
|
Attend Daycare
Unreported
|
4 Participants
n=10 Participants
|
|
Attend Work
In Person
|
49 Participants
n=10 Participants
|
|
Attend Work
Remote or Virtual
|
6 Participants
n=10 Participants
|
|
Attend Work
Hybrid (both remote / in person)
|
21 Participants
n=10 Participants
|
|
Attend Work
No
|
122 Participants
n=10 Participants
|
|
Attend Work
Unreported
|
2 Participants
n=10 Participants
|
|
Tobacco
Yes
|
6 Participants
n=10 Participants
|
|
Tobacco
Secondhand Exposure Only
|
6 Participants
n=10 Participants
|
|
Tobacco
No
|
185 Participants
n=10 Participants
|
|
Tobacco
Unreported
|
3 Participants
n=10 Participants
|
|
Days of Illness Prior to Presentation
|
3.04 days
STANDARD_DEVIATION 1.90 • n=10 Participants
|
|
Severity of Illness
Mild
|
39 Participants
n=10 Participants
|
|
Severity of Illness
Moderate
|
137 Participants
n=10 Participants
|
|
Severity of Illness
Severe
|
20 Participants
n=10 Participants
|
|
Severity of Illness
Unreported
|
4 Participants
n=10 Participants
|
|
Reported Exposure to someone else ill
Yes
|
36 Participants
n=10 Participants
|
|
Reported Exposure to someone else ill
No
|
84 Participants
n=10 Participants
|
|
Reported Exposure to someone else ill
Unsure
|
80 Participants
n=10 Participants
|
|
Flu Vaccine (current year)
Yes
|
111 Participants
n=10 Participants
|
|
Flu Vaccine (current year)
No
|
83 Participants
n=10 Participants
|
|
Flu Vaccine (current year)
Unreported
|
6 Participants
n=10 Participants
|
|
Coronavirus (COVID) Vaccine within the last 12 months
Yes
|
87 Participants
n=10 Participants
|
|
Coronavirus (COVID) Vaccine within the last 12 months
No
|
103 Participants
n=10 Participants
|
|
Coronavirus (COVID) Vaccine within the last 12 months
Unreported
|
10 Participants
n=10 Participants
|
|
Symptoms
Sore Throat
|
193 Participants
n=10 Participants
|
|
Symptoms
Fever
|
88 Participants
n=10 Participants
|
|
Symptoms
Chills
|
68 Participants
n=10 Participants
|
|
Symptoms
Cough
|
134 Participants
n=10 Participants
|
|
Symptoms
Wheeze
|
20 Participants
n=10 Participants
|
|
Symptoms
SOB
|
28 Participants
n=10 Participants
|
|
Symptoms
Rhinorrhea
|
105 Participants
n=10 Participants
|
|
Symptoms
Sinus Congestion
|
102 Participants
n=10 Participants
|
|
Symptoms
Conjunctivitis
|
2 Participants
n=10 Participants
|
|
Symptoms
Loss of Smell
|
7 Participants
n=10 Participants
|
|
Symptoms
Loss of Taste
|
7 Participants
n=10 Participants
|
|
Symptoms
Malaise
|
74 Participants
n=10 Participants
|
|
Symptoms
Myalgia
|
42 Participants
n=10 Participants
|
|
Symptoms
Arthralgia
|
15 Participants
n=10 Participants
|
|
Symptoms
Ear Pain
|
42 Participants
n=10 Participants
|
|
Symptoms
Headache
|
105 Participants
n=10 Participants
|
|
Symptoms
Diarrhea
|
9 Participants
n=10 Participants
|
|
Symptoms
Loss of Appetite
|
48 Participants
n=10 Participants
|
|
Symptoms
Vomiting
|
17 Participants
n=10 Participants
|
|
Symptoms
Abdominal Pain
|
17 Participants
n=10 Participants
|
|
Symptoms
Other
|
16 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 20 minutesSPOTFIRE ST results by count.
Outcome measures
| Measure |
Pediatric Detections
n=117 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=83 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Summary of Test Results
Human Metapneumovirus
|
2 Participants
|
2 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Adenovirus
|
6 Participants
|
1 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Seasonal Coronavirus
|
13 Participants
|
14 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Rhino/Enterovirus
|
21 Participants
|
7 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Influenza A
|
29 Participants
|
14 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Influenza B
|
9 Participants
|
1 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Parainfluenza
|
5 Participants
|
1 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
RSV
|
11 Participants
|
6 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Group A Strep
|
36 Participants
|
9 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Group C/G Strep
|
1 Participants
|
2 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
C. pneumoniae
|
3 Participants
|
0 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
M. pneumoniae
|
14 Participants
|
1 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
Negative Test
|
18 Participants
|
33 Participants
|
|
Aim 2 Clinical Outcome: Summary of Test Results
More than one pathogen
|
44 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksData collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=200 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing
Rapid Strep Antigen test
|
—
|
40 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing
COVID PCR test
|
—
|
21 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing
Rapid Flu test
|
—
|
16 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing
Rapid RSV test
|
—
|
16 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants who follow had follow up with Rapid Flu Test
Data collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
n=13 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=3 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results
Positive SPOTFIRE test
|
0 Participants
|
3 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results
Negative SPOTFIRE test
|
13 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants who follow had follow up with Rapid RSV Test
Data collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
n=14 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=2 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results
Negative SPOTFIRE test
|
14 Participants
|
0 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results
Positive SPOTFIRE test
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants who follow had follow up with COVID PCR Test
Data collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
n=18 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=3 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results
Positive SPOTIFRE test
|
12 Participants
|
0 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results
Negative SPOTIFRE test
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants who follow had follow up with Rapid Strep Antigen Test
Data collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
n=31 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=9 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results
Positive SPOTFIRE test
|
3 Participants
|
9 Participants
|
|
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results
Negative SPOTFIRE test
|
28 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Number analyzed documents the number of participants diagnosed in each sub-group.
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)
Outcome measures
| Measure |
Pediatric Detections
n=117 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=83 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens
Treatable (FluA/B, GAS, Mpn, Cpn)
|
80 Participants
|
23 Participants
|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens
Influenza detected and prescribed antiviral
|
11 Participants
|
6 Participants
|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens
Treatable bacterial pathogen detection and prescribed antibiotic (GAS, Mpn, Cpn)
|
49 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Number analyzed documents the number of participants diagnosed in each sub-group.
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.
Outcome measures
| Measure |
Pediatric Detections
n=66 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=73 Participants
Adult participants
|
|---|---|---|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
Patients without treatable bacterial detection prescribed an antibiotic
|
10 Participants
|
10 Participants
|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
SPOTFIRE negative
|
6 Participants
|
7 Participants
|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
SPOTFIRE single virus
|
2 Participants
|
2 Participants
|
|
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
SPOTFIRE multiple viruses
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to approximately 4 months)Population: Number analyzed changes to illustrate sub-populations.
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=200 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey
Completed Survey
|
—
|
186 Participants
|
|
Aim 3: Participant Satisfaction Survey
Swab Acceptable
|
—
|
177 Participants
|
|
Aim 3: Participant Satisfaction Survey
Took Test before Visit
|
—
|
138 Participants
|
|
Aim 3: Participant Satisfaction Survey
Liked Testing before Visit
|
—
|
121 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=186 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Not Relieved
|
—
|
3 Participants
|
|
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Fairly Relieved
|
—
|
20 Participants
|
|
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Slightly Relieved
|
—
|
7 Participants
|
|
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Very Relieved
|
—
|
74 Participants
|
|
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Relieved
|
—
|
82 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey, data missing from 1 participant
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=185 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Very Satisfied
|
—
|
104 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Satisfied
|
—
|
67 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Fairly Satisfied
|
—
|
9 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Slightly Satisfied
|
—
|
3 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Not Satisfied
|
—
|
2 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=186 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Very Satisfied
|
—
|
103 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Satisfied
|
—
|
62 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Fairly Satisfied
|
—
|
14 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Slightly Satisfied
|
—
|
7 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Not Satisfied
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=186 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Very Satisfied
|
—
|
90 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Satisfied
|
—
|
72 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Fairly Satisfied
|
—
|
11 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Slightly Satisfied
|
—
|
8 Participants
|
|
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Not Satisfied
|
—
|
5 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=186 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Very Useful
|
—
|
128 Participants
|
|
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Useful
|
—
|
38 Participants
|
|
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Fairly useful
|
—
|
12 Participants
|
|
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Slightly Useful
|
—
|
3 Participants
|
|
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Not Useful
|
—
|
5 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Of participants who completed the survey, data missing from 1 participant
Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=185 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Very Likely
|
—
|
132 Participants
|
|
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Likely
|
—
|
41 Participants
|
|
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Fairly Likely
|
—
|
7 Participants
|
|
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Slightly Likely
|
—
|
4 Participants
|
|
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?
Not Likely
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: Providers not enrolled as their participation was considered program evaluation. Some voluntarily completed surveys before and after testing patients.
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.
Outcome measures
| Measure |
Pediatric Detections
n=33 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=28 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Utility Survey
Patients over the age of 65 years with acute pharyngitis symptoms
|
5.50 rank order score
|
5.51 rank order score
|
|
Aim 3: Provider Utility Survey
Adults aged 18-64 years with acute pharyngitis symptoms
|
5.09 rank order score
|
4.69 rank order score
|
|
Aim 3: Provider Utility Survey
Preschool and school aged children (3-17 years) with acute pharyngitis symptoms
|
2.63 rank order score
|
2.46 rank order score
|
|
Aim 3: Provider Utility Survey
Toddlers (1-2 years) with febrile illness (may or may not be able to report pharyngitis symptoms)
|
3.38 rank order score
|
3.59 rank order score
|
|
Aim 3: Provider Utility Survey
Infants (less than 12 months) with acute febrile illness
|
3.91 rank order score
|
4.38 rank order score
|
|
Aim 3: Provider Utility Survey
Patients with chronic medical comorbidities with acute pharyngitis symptoms
|
4.13 rank order score
|
4.13 rank order score
|
|
Aim 3: Provider Utility Survey
Patient with immunocompromising conditions or medications with acute pharyngitis symptoms
|
3.38 rank order score
|
3.24 rank order score
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: All providers who voluntarily completed surveys after patient testing.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=56 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - How Often Test Used?
Often
|
—
|
5 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often Test Used?
Sometimes
|
—
|
13 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often Test Used?
Rarely
|
—
|
15 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often Test Used?
Never
|
—
|
23 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Very Easy
|
—
|
20 Participants
|
|
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Easy
|
—
|
7 Participants
|
|
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Neutral
|
—
|
6 Participants
|
|
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Difficult
|
—
|
0 Participants
|
|
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?
Very Difficult
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Very Prepared
|
—
|
8 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Prepared
|
—
|
13 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Neutral
|
—
|
9 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Slightly Prepared
|
—
|
2 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?
Not Prepared
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=32 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?
Often
|
—
|
2 Participants
|
|
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?
Sometimes
|
—
|
10 Participants
|
|
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?
Rarely
|
—
|
11 Participants
|
|
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?
Never
|
—
|
9 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Extremely Useful
|
—
|
13 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Very Useful
|
—
|
11 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Moderately Useful
|
—
|
4 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Slightly Useful
|
—
|
3 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?
Not Useful
|
—
|
2 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Extremely Useful
|
—
|
13 Participants
|
|
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Very Useful
|
—
|
11 Participants
|
|
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Moderately Useful
|
—
|
6 Participants
|
|
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Slightly Useful
|
—
|
2 Participants
|
|
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Not Useful
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
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)
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Always
|
—
|
6 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Often
|
—
|
8 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Sometimes
|
—
|
8 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Rarely
|
—
|
8 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Never
|
—
|
3 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Always
|
—
|
6 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Often
|
—
|
20 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Sometimes
|
—
|
5 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Rarely
|
—
|
2 Participants
|
|
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Never
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)Population: The providers who used SPOTFIRE and answered the question.
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.
Outcome measures
| Measure |
Pediatric Detections
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=33 Participants
Adult participants
|
|---|---|---|
|
Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?
Before Visit
|
—
|
27 Participants
|
|
Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?
During Visit
|
—
|
6 Participants
|
|
Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?
After Visit
|
—
|
0 Participants
|
POST_HOC outcome
Timeframe: up to 20 minutesA separate analysis looking at pathogen detections for viral and bacterial pathogens was performed.
Outcome measures
| Measure |
Pediatric Detections
n=117 Participants
Pediatric participants are defined as less than 18 years old.
|
Adult Detections
n=83 Participants
Adult participants
|
|---|---|---|
|
Pathogen Detections for Viral and Bacterial Pathogens
Nothing detected
|
18 Participants
|
33 Participants
|
|
Pathogen Detections for Viral and Bacterial Pathogens
Positive for single virus
|
34 Participants
|
37 Participants
|
|
Pathogen Detections for Viral and Bacterial Pathogens
Positive for multiple viruses
|
14 Participants
|
1 Participants
|
|
Pathogen Detections for Viral and Bacterial Pathogens
Positive for single bacteria
|
21 Participants
|
7 Participants
|
|
Pathogen Detections for Viral and Bacterial Pathogens
Positive for multiple bacteria
|
1 Participants
|
0 Participants
|
|
Pathogen Detections for Viral and Bacterial Pathogens
Positive for virus and bacterial pathogens
|
29 Participants
|
5 Participants
|
Adverse Events
Eligible SPOTFIRE ST Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexander Lepak, MD, FIDSA
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-1545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place