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The Making of BIOFIRE® SPOTFIRE®

The COVID-19 pandemic has changed the landscape for respiratory diagnostics, and we’re keeping the pace right alongside it. This article talks about the origins of our new multiplex PCR diagnostic solution, which can be deployed on site and deliver results on a comprehensive panel of respiratory targets in about 15 minutes.

A mother comes into an urgent care facility with her 5-year-old son. The boy presents with respiratory symptoms—cough, runny nose, fever—and the mother is concerned it may be COVID-19. The doctor tests for COVID-19, but the result comes back negative. Understandably concerned, the mother demands an answer, so the doctor takes another swab that would test for additional pathogens; however, the results will take time to come in. Wanting to give her child relief immediately, the mother asks the doctor for treatment options. The doctor prescribes broad-spectrum antibiotics in the hopes they will relieve the symptoms.

But it’s not until after the mother fills the prescription and begins administering the antibiotics that the doctor gets back the results: the boy has a viral infection caused by respiratory syncytial virus (RSV), a key player in the simultaneous circulation of influenza, COVID-19, and RSV during the respiratory season. The doctor must now get back to the mother and inform her that the antibiotics will not be effective and that the best therapy is to manage symptoms and monitor for signs of more severe illness.

This scenario is unfortunately not uncommon in point-of-care (POC) settings. Patients visit urgent care and other POC centers because of their streamlined and convenient process—they come wanting fast answers and relief. However, some clinics don’t have the resources to perform lab-grade testing onsite, which often leaves providers to make diagnoses and prescribe treatment based solely on clinical signs and symptoms. This can have negative impacts on patient management and antimicrobial stewardship.

bioMérieux recognized this critical gap in patient care and began developing the BIOFIRE® SPOTFIRE® System in 2016. Fast forward to 2023 and we have launched the SPOTFIRE SYSTEM, along with the BIOFIRE® SPOTFIRE® Respiratory Panel and the BIOFIRE® SPOTFIRE® Respiratory Panel Mini, with FDA clearance and a CLIA waiver.

What Went Into SPOTFIRE®

When developing the SPOTFIRE Respiratory Solution, bioMérieux had three things in mind:

  1. Making an instrument easy enough to use in a CLIA-waived setting
  2. Bringing PCR-based testing to the point of care
  3. Delivering syndromic results in a clinically relevant time frame

From the onset, we knew we had to bring the syndromic approach to point-of-care settings. And given that the pandemic highlighted the need for better POC respiratory testing, we turned to the BIOFIRE® Respiratory 2.1 (RP2.1) Panel.

With a target menu of 22 probable pathogens, including SARS-CoV-2, the BIOFIRE R2.1 Panel was a game changer during the pandemic. The associated risk with COVID-19 made differential respiratory diagnoses increasingly important, as they helped clinicians determine the appropriate quarantine and treatment measures.

However, the BIOFIRE RP2.1 Panel was created for a laboratory setting, and we needed to bring that same quality of testing to the CLIA-waived market. In that vein, we tailored the SPOTFIRE System’s panel menus to include the most common pathogens that cause respiratory tract infections. We also optimized the chemistry to run faster and perform better. And with that the expanded SPOTFIRE R Panel was born. One PCR test of 15 targets—including 11 viruses and four bacteria—can produce results in about 15 minutes. The targeted SPOTFIRE R Panel Mini, developed alongside the SPOTFIRE R Panel, tests for 5 viral targets in the same time frame, bringing new possibilities and options to clinicians.

Another game-changing element is the user-friendly nature of the SPOTFIRE System interface. Keeping testing in-house may streamline the diagnostic workflow and get answers to patients during their clinic visit, which is why the SPOTFIRE System is designed specifically to be used by non-laboratory professionals.

Meeting the Needs of the POC Market

Speed. Convenience. Accuracy. Satisfaction. This is the recipe for success at the point of care and the foundation for the SPOTFIRE Respiratory Solution. Below is an overview of how the SPOTFIRE R and R Mini Panels on the SPOTFIRE System can fulfill these needs for point-of-care practices.

test tube One swab, one test

The last thing patients want is to have multiple swabs taken in one visit, especially when it comes to children. With one nasopharyngeal sample, the syndromic SPOTFIRE Panels test for the most common causes of respiratory infections.

clock Fast and accurate results

With results in about 15 minutes, the SPOTFIRE® System empowers clinicians to give their patients the answers and informed treatment they need during their visit.

spotfire system Lab-grade testing onsite

The SPOTFIRE® System allows point-of-care clinicians to perform lab-grade PCR testing directly onsite. Its easy interface, streamlined workflow, and small footprint (slightly bigger than a sheet of paper) allow clinicians to easily install the device and run tests in house.

heart Patient satisfaction and retention

Sending patients home with the correct therapy not only supports antimicrobial stewardship efforts but can potentially help strengthen relationships with the patient.

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