Rapid Test for Strep Throat

Overseen By Shari Barlow

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Antivirals, Antibiotics

Disqualifiers: Anatomic anomalies, Previous participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rapid test for strep throat called SPOTFIRE ST. The goal is to assess its usefulness and satisfaction for both urgent care doctors and patients. Suitable participants include those who have experienced a sore throat or fever in the past week and have conditions such as asthma or heart disease, or are taking medications that weaken the immune system. Participation requires about 25 minutes. As an unphased trial, this study provides a unique opportunity to contribute to the development of a potentially valuable diagnostic tool.

Do I have to stop taking my current medications to join the trial?

Yes, if you are already on an antiviral or antibiotic medication, you cannot participate in the trial.

What prior data suggests that the SPOTFIRE ST System is safe?

Research has shown that the SPOTFIRE ST System safely diagnoses respiratory and sore throat infections. It uses polymerase chain reaction (PCR) to detect various viruses and bacteria. This automated test provides quick results, reducing the need for complex procedures.

The FDA has approved the SPOTFIRE ST System for detecting germs in respiratory infections, indicating it meets safety standards when used correctly. Although specific side effects in people aren't detailed, its FDA approval for other uses suggests general safety.

For those considering joining the trial, knowing that this system is already used in medical settings may reassure you about its safety. Always consult the trial team or your doctor if you have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPOTFIRE ST System because it offers a rapid and precise way to diagnose strep throat, potentially transforming how quickly patients receive appropriate care. Unlike traditional throat cultures and rapid antigen tests, which can take longer and may require follow-up confirmations, the SPOTFIRE ST System aims to deliver accurate results in a much shorter time frame. This speed in diagnosis could lead to quicker treatment decisions, reducing unnecessary antibiotic use and improving patient outcomes.

What evidence suggests that the SPOTFIRE ST System is effective for diagnosing strep throat?

Research has shown that the SPOTFIRE ST System, which participants in this trial may receive, effectively identifies the germs causing sore throats. It employs a method called PCR to detect the genetic material of viruses and bacteria responsible for sore throat symptoms. This system tests for common causes like the flu and the common cold. By accurately identifying these germs, the test aids doctors in quickly determining the best treatment. Early evidence suggests that this method performs well in urgent care settings. ^{3 4 6 7 8}

Who Is on the Research Team?

Alexander Lepak, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for up to 200 individuals with sore throat symptoms, seeking treatment at urgent care. The study will take about 25 minutes of their time.

Inclusion Criteria

I am between 3 to 17 years old and have a sore throat.

I have a weak immune system and currently have a sore throat.

My child is between 1 and 2 years old and has a fever.

Exclusion Criteria

Previous participation in the study

Unable to read and understand or refusal to sign the appropriate informed consent/assent forms

Refusal to provide their demographics, household information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Testing

Participants undergo the SPOTFIRE ST pharyngitis test to evaluate its performance and clinical utility

25 minutes

1 visit (in-person)

Follow-up

Participants are monitored for follow-up testing and resultant prescriptions

3 weeks

Data collected via electronic medical record review

Satisfaction and Utility Evaluation

Participant and provider satisfaction and future use opportunities of the SPOTFIRE ST Panel testing platform are evaluated

up to 4 months

Surveys emailed post-testing

What Are the Treatments Tested in This Trial?

Interventions

• SPOTFIRE ST System

Trial Overview The SPOTFIRE ST System, a new point-of-care test for pharyngitis (sore throat), is being evaluated for its effectiveness and the satisfaction it provides to both healthcare providers and patients.

How Is the Trial Designed?

Group I: Eligible SPOTFIRE ST Participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

BioMérieux

Industry Sponsor

Trials

62

Recruited

43,500+

Pierre Boulud

BioMérieux

Chief Executive Officer since 2023

Degree in Biology from Lyon I University, Graduate of HEC Montreal Business School

Dr. Charles K. Cooper

BioMérieux

Chief Medical Officer since 2024

MD from Georgetown University School of Medicine, Specialized in Infectious Diseases and Epidemiology at University of Maryland, Baltimore

Published Research Related to This Trial

The Rapid Antigen Diagnostic Test (RADT) demonstrated a sensitivity of 75% and a specificity of 96% in detecting Group A Streptococcus (GAS) in patients with sore throat, indicating it is a reliable tool for quick diagnosis.

With a prevalence of GAS at 22.5% in the study population, the RADT can help identify patients at high risk for GAS infection, but improvements in sensitivity are needed for more accurate early diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of the diagnostic methods for Group A streptococcal sore throat in two reference hospitals in Yaounde, Cameroon. Gonsu, HK., Bomki, CM., Djomou, F., et al.[2018]

The 2016 SHOT Report highlights that blood transfusion components are very safe, with significant reductions in risks such as transfusion-related acute lung injury and infection transmission, largely due to improved safety measures and the use of male donors for plasma components.

Human errors account for 87% of transfusion incidents, emphasizing the need for better bedside checks and standardized information technology systems to prevent wrong transfusions and associated complications, such as transfusion-associated circulatory overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious hazards of transfusion - conference report: celebration of 20 years of UK haemovigilance. Bolton-Maggs, PHB.[2018]

The Becton-Dickinson Link 2 Strep A Rapid Test (RADT) demonstrated good sensitivity (83.1%) and specificity (93.3%) for diagnosing streptococcal pharyngitis in children, with improved sensitivity observed as more clinical criteria were met.

Implementing RADT in clinical practice significantly reduced unnecessary antibiotic prescriptions, especially among paediatricians with access to rapid testing, highlighting its role in promoting appropriate antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a rapid antigen detection test in the diagnosis of streptococcal pharyngitis in children and its impact on antibiotic prescription. Maltezou, HC., Tsagris, V., Antoniadou, A., et al.[2022]

The SD Bioline Strep A Ultra test demonstrated high sensitivity (97.4%) and specificity (90.8%) for diagnosing bacterial pharyngitis in a study of 343 children, indicating it is a reliable tool for detecting Group A Streptococcus.

The test's positive rate varied significantly with the number of colony forming units, suggesting it can provide semi-quantitative results, which may enhance clinical decision-making in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the SD Bioline Strep A Ultra Test in Relation With Number of Colony Forming Units and Color Intensity. Ma, SH., Choi, WH., Park, H., et al.[2019]

The Pacific Biotech CARD STREP A test demonstrated a sensitivity of 76.1% and a specificity of 98.7% when evaluated against conventional culture methods for detecting group A streptococci in throat specimens.

Despite its high specificity, the relatively low sensitivity raises concerns about the test's effectiveness as a reliable screening tool for strep throat, suggesting it may miss some positive cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the pacific biotech CARDS STREP A test for detecting group A streptococci from cases of pharyngitis. Manasse, RJ.[2021]

Continuous monitoring and integration of scientific advances are essential for ensuring the highest safety standards in transfusion medicine, particularly in adapting new research findings to clinical applications.

Genomic screening and virus inactivation processes are being evaluated to further reduce the risk of viral contamination in blood products, while ongoing research is exploring various substitution products to enhance transfusion safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transfusion medicine in adults. Perspectives]. Lapierre, V., Hervé, P.[2016]

The BioFire FilmArray gastrointestinal panel identified pathogens in 39.6% of patients with gastroenteritis, compared to 28.6% detected by conventional PCR testing, highlighting its superior efficacy in diagnosing infections.

Implementing the FilmArray reduced the turnaround time for test results from 53 hours to 16 hours, allowing for quicker patient management, including earlier removal from isolation and reduced antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the BioFire FilmArray gastrointestinal panel on patient care and infection control. Machiels, JD., Cremers, AJH., van Bergen-Verkuyten, MCGT., et al.[2020]

The ePlex Respiratory Pathogen panel demonstrated over 95% agreement with the BioFire Respiratory Panel in detecting 19 viruses and 2 bacteria from 2,908 nasopharyngeal swab specimens, indicating high efficacy in diagnosing respiratory infections.

The assay showed excellent reproducibility, achieving 100% consistency for most pathogens, which highlights its reliability as a rapid and sensitive tool for identifying common respiratory pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs. Babady, NE., England, MR., Jurcic Smith, KL., et al.[2019]

The rapid strep test is effective not only for diagnosing pharyngitis but also for early management of skin infections caused by streptococcus, which can lead to serious complications.

In a study involving 15 patients, those with positive rapid strep test results were able to receive immediate and specific treatment, leading to excellent outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the rapid streptococcus test in extrapharyngeal sites. Bourgeois, SD., Bourgeois, MH.[2004]

The implementation of nucleic acid testing (NAT) significantly reduced the transmission of viruses in blood components, with red blood cell concentrates showing a decrease from 1.0 to 0.5 cases per million units and platelet concentrates dropping from 3.0 to 0.0 cases per million units.

Despite improvements in viral safety, bacterial infections related to platelet concentrates did not decrease, and the frequency of severe allergic transfusion reactions increased significantly, highlighting the need for ongoing evaluation of blood safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of measures aimed to reduce serious adverse transfusion reactions (hemovigilance data from 1997 to 2008)]. Funk, MB., Günay, S., Lohmann, A., et al.[2019]

The Serious Hazards of Transfusion (SHOT) scheme has analyzed 2630 transfusion safety events since its establishment in 1996, leading to key recommendations that have improved blood safety practices in the UK.

SHOT's findings have highlighted critical issues such as the decline in transfusion-related graft vs host disease due to leucodepletion, while also identifying transfusion-related acute lung injury and bacterial contamination as significant risks, prompting the development of targeted safety strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious hazards of transfusion: a decade of hemovigilance in the UK. Stainsby, D., Jones, H., Asher, D., et al.[2022]

The Mirasol PRT System effectively reduces pathogens and inactivates white blood cells in blood products using riboflavin and UV light, ensuring safer transfusions.

A comprehensive toxicology program showed no treatment-related toxicity in various studies, confirming the safety of the Mirasol PRT System for use in blood products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity testing of a novel riboflavin-based technology for pathogen reduction and white blood cell inactivation. Reddy, HL., Dayan, AD., Cavagnaro, J., et al.[2013]

In a study of 350 nasopharyngeal swab samples from symptomatic patients, the BioFire FilmArray Respiratory Panel and Luminex NxTAG Respiratory Pathogen Panel showed similar overall accuracy, while the GenMark eSensor Respiratory Viral Panel had significantly different performance compared to both.

The positive agreement rates were high for all three assays, with GenMark showing the highest at 97.3%, but BioFire had increased false positives for endemic coronaviruses, highlighting the importance of choosing the right test for accurate respiratory pathogen detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Performance of the Luminex NxTAG Respiratory Pathogen Panel, GenMark eSensor Respiratory Viral Panel, and BioFire FilmArray Respiratory Panel. Popowitch, EB., Kaplan, S., Wu, Z., et al.[2022]

The BioFire COVID-19 Test and Respiratory Panel 2.1 (RP2.1) demonstrated 100% concordance with a laboratory-developed PCR assay in detecting SARS-CoV-2 in clinical samples, indicating high accuracy.

Both tests are highly sensitive and effective for rapid SARS-CoV-2 detection in clinical laboratories, having received emergency use authorization from the FDA and Health Canada.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the BioFire® COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples. Eckbo, EJ., Locher, K., Caza, M., et al.[2023]

Citations

1. biomerieux.com biomerieux.com/content/dam/biomerieux-com/service-support/support-documents/instructions-for-use-and-manuals/BFR0001-7220-BIOFIRE-SPOTFIRE-R-ST-Panel-Instructions-for-Use-EN.pdf

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel The SPOTFIRE R/ST Panel, designed for use with the SPOTFIRE System, is a polymerase chain reaction (PCR) based sample-to-answer diagnostic test that ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K232954.pdf

A 510(k) Number K232954 B Applicant BioF The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel detects and identifies nucleic acids from the following pathogens: Adenovirus, ...

3. biofiredefense.com biofiredefense.com/products/biofire-spotfire/

The BIOFIRE ® SPOTFIRE ® System The SPOTFIRE R/ST Panel Mini tests for the 5 most probable viruses or bacteria that cause respiratory and sore throat symptoms, including influenza, rhinovirus, ...

4. biofiredx.com biofiredx.com/wp-content/uploads/BFR0001-0955-01-SPOTFIRE-R-ST-Lab-Verification-Tech-Note-OUS.pdf

BFR0001-0955-01-SPOTFIRE-R-ST- ... This document provides examples of procedures to assist your laboratory in developing a protocol for the verification of the SPOTFIRE R/ST Panel performance ...

5. go.biomerieux.com go.biomerieux.com/spotfire/rst

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel The new SPOTFIRE R/ST Panel offers the flexibility to choose either respiratory or sore throat testing based on the patient's signs and symptoms.

6. biomerieux.com biomerieux.com/content/dam/biomerieux-com/service-support/support-documents/instructions-for-use-and-manuals/BFR0002-8509-BIOFIRE-SPOTFIRE-R-ST-Panel-Mini-Instructions-for-Use-EN.pdf

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel ... The SPOTFIRE R/ST Panel Mini, designed for use with the SPOTFIRE System, is an automated polymerase chain reaction. (PCR)-based sample-to-answer diagnostic test ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/clia_waivers/CW230018.pdf

CW230018.pdf - accessdata.fda.gov The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel detects and identifies nucleic acids from the following pathogens: Adenovirus, ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243544.pdf

August 14, 2025 BioFire Diagnostics, LLC Karli Plenert Sr ... The BIOFIRE SPOTFIRE R/ST Panel Mini (SPOTFIRE R/ST Panel Mini) simultaneously identifies 5 different respiratory viral pathogens in ...