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

200 Participants Needed

Trial Summary

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 data supports the idea that Rapid Test for Strep Throat is an effective treatment?

The available research shows that the rapid strep test is a valuable tool for managing pharyngitis, which is a sore throat caused by strep bacteria. It allows for immediate treatment with specific therapy, leading to excellent outcomes. This is supported by a study involving 15 patients, where the test helped in early management and treatment of infections. ^{1 2 3 4 5}

What safety data exists for the Rapid Test for Strep Throat?

The provided research does not contain any safety data related to the Rapid Test for Strep Throat or its alternative names (SPOTFIRE ST System, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, BIOFIRE SPOTFIRE R/ST Panel). The research focuses on transfusion medicine and related safety measures, which are not relevant to the strep throat test. ^{6 7 8 9 10}

Is the rapid test for strep throat a promising treatment?

Yes, the rapid test for strep throat is promising because it helps quickly identify infections, allowing for immediate treatment. This can lead to excellent outcomes, prevent complications, and reduce the spread of the infection. ^{1 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Alexander Lepak, MD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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.

I have other health issues like heart or kidney problems and currently have a sore throat.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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 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 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 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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of the rapid streptococcus test in extrapharyngeal sites. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of the BioFire FilmArray gastrointestinal panel on patient care and infection control. [2020]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative Performance of the Luminex NxTAG Respiratory Pathogen Panel, GenMark eSensor Respiratory Viral Panel, and BioFire FilmArray Respiratory Panel. [2022]

5. United States 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. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Transfusion medicine in adults. Perspectives]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Serious hazards of transfusion: a decade of hemovigilance in the UK. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Toxicity testing of a novel riboflavin-based technology for pathogen reduction and white blood cell inactivation. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of measures aimed to reduce serious adverse transfusion reactions (hemovigilance data from 1997 to 2008)]. [2019]

11. Korea (South) 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. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. Uganda 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. [2018]

14. England 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. [2022]