Integration of Group A Streptococcus Rapid Tests with the Open Fluidic CandyCollect Device

Area of Science:

• Oral fluid diagnostics
• Microbiology
• Medical device development

Background:

• Group A Streptococcus (GAS) pharyngitis is a common bacterial infection.
• Current diagnostic methods often rely on uncomfortable pharyngeal swabs.
• There is a need for user-friendly and effective oral sampling devices for pathogen detection.

Purpose of the Study:

• To evaluate the CandyCollect device, an oral fluid sampler, for Group A Streptococcus detection.
• To optimize the integration of the CandyCollect device with a rapid antigen detection test (RADT).
• To assess the performance of the combined system using clinical samples from pediatric patients.

Main Methods:

• Developed and optimized a protocol for using the CandyCollect device with a RADT kit.
• Conducted in vitro experiments with spiked saliva to determine optimal reagents and elution volumes.
• Validated the optimized protocol using clinical oral fluid samples from pediatric patients diagnosed with GAS pharyngitis.

Main Results:

• The CandyCollect device coupled with RADT detected GAS at concentrations as low as 1.5×10^5 CFU/mL in vitro.
• Image analysis quantified lateral flow assay (LFA) results, providing objective signal-to-baseline ratios (SBR).
• In clinical testing, the CandyCollect-RADT system yielded positive results in 4 out of 6 pediatric patients with confirmed GAS pharyngitis.

Conclusions:

• The CandyCollect device is a viable and comfortable oral sampling tool for GAS detection.
• The optimized protocol demonstrates successful integration with existing RADT kits for improved user experience.
• This approach shows promise for non-invasive, rapid diagnosis of GAS infections, particularly in pediatric populations.