Saliva Testing for Strep Throat

Not currently recruiting at 2 trial locations
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if saliva can diagnose strep throat as accurately as the usual throat swab. Researchers will compare saliva samples to traditional throat swabs to assess result consistency and will also test faster methods for quicker outcomes. Saliva testing could simplify strep throat diagnosis, especially for children who find throat swabs uncomfortable. The trial seeks participants under 19 who have already undergone a throat swab test and can provide a saliva sample. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could simplify strep throat diagnosis for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing methods rather than medication use.

What prior data suggests that saliva collection is safe for diagnosing GAS infection?

A previous study found that collecting saliva is safe and easy. Problems during saliva tests are very unlikely, indicating no known safety issues with using saliva for testing. Saliva collection is often simpler and more comfortable, especially for children, compared to the usual throat swab method. This makes it a promising way to diagnose strep throat without causing discomfort or harm.12345

Why are researchers excited about this trial?

Researchers are excited about the saliva testing method for diagnosing strep throat because it offers a non-invasive, easy-to-use alternative to the current standard, which typically involves throat swabs. Unlike traditional swabs that can be uncomfortable and require professional collection, saliva samples can be self-collected, making the process much more convenient and less daunting, especially for children. This method could potentially streamline the diagnostic process, reducing the need for clinical visits and providing rapid results, which is a significant advantage in managing and treating strep throat efficiently.

What evidence suggests that saliva testing is effective for diagnosing strep throat?

Research has shown that saliva tests can accurately diagnose Group A strep infections. Studies have found these tests to be highly reliable in detecting the bacteria that cause strep throat. One study showed that a saliva test correctly identified all true positive cases, achieving 100% accuracy. This trial will evaluate the effectiveness of self-collected saliva samples for diagnosing strep throat. Using saliva for testing could significantly improve the process, especially for children, as it is easier and less uncomfortable than throat swabs. Early results suggest that saliva testing is as effective as traditional methods, but faster and more child-friendly.13467

Are You a Good Fit for This Trial?

This study is for individuals, particularly children, who may have a streptococcal infection or strep throat. It's designed to see if saliva can be used instead of throat swabs for diagnosis. The specific eligibility criteria are not provided but would typically include having symptoms of a GAS infection.

Inclusion Criteria

I have given a sample for a throat infection test as advised by my doctor.
I am under 19 years old.
I can provide a saliva sample.

Exclusion Criteria

Unable to provide a saliva sample
I or my guardian cannot give consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sample Collection

Participants self-collect saliva samples for testing and comparison with throat swab testing

1 day
1 visit (in-person)

Laboratory Testing

Saliva and throat swab samples are tested using different methods, including molecular testing and bacterial culture

48 hours

Follow-up

Participants are monitored for safety and effectiveness of the saliva testing method

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Saliva Collection
Trial Overview The trial is testing the effectiveness of using saliva samples to diagnose Group A Streptococcus (GAS) infections. It compares saliva sample results with traditional throat swab tests and evaluates different lab testing methods, including faster molecular techniques.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Saliva collectionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Citations

Diagnostic accuracy of a rapid nucleic acid test for group ...Our main outcome measure is the sensitivity of Abbott's ID NOW STREP A 2 on saliva samples. We based our sample size calculation on the ...
Diagnostic Accuracy of Rapid Molecular Tests for Group A ...Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard ...
Diagnostic accuracy of rapid nucleic acid tests for group A ...The high diagnostic accuracy of RNATs may allow their use as stand-alone tests to diagnose group A streptococcus pharyngitis.
The potential of saliva as an accessible and sensitive ...This Personal View seeks to summarise the existing evidence for the use of saliva in detecting respiratory pathogens, beyond SARS-CoV-2.
Use of saliva-based qPCR diagnostics for the accurate, ...Positive predictive value, negative predictive value, and accuracy of our saliva-based diagnostic test were 100 % (Table 2). Table 2: Saliva- ...
Streptococcus pyogenes - Pathogen Safety Data SheetsInitial symptoms of streptococcal pharyngitis include sore throat, malaise, fever, and headache. Children may also experience nausea, vomiting, ...
At-home saliva sampling for capture of respiratory pathogensSaliva samples are an alternative to pharyngeal swabs. To improve the testing experience for strep throat, we developed a novel lollipop-inspired sampling ...
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