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The Value of the Syndromic Approach in an Outpatient Setting

Onsite testing is directly tied to patient satisfaction. In fact, 77% of patients prefer onsite laboratory services, and 67% of patients will drive up to 20 minutes to visit a clinic with onsite lab services.1 But not all onsite infectious disease testing is the same. Some rapid tests offer quick results, but lower sensitivities. Most rapid tests only target one or two pathogens, which can lead to serial testing—or sending the patient home without a solid answer.

“You must have a cold” is not satisfying—especially if patients are left with a lingering worry that the rapid COVID-19 or influenza tests they received may have returned a false negative.2 When it comes to infectious gastroenteritis, traditional testing is slow and offers a low diagnostic yield.3 This can lead to clinicians making treatment decisions without laboratory results.

Fortunately, onsite syndromic infectious disease testing provides fast, accurate, and comprehensive results that can help provide patients with concrete answers and enable clinicians to offer appropriate therapy faster.

The Syndromic Approach

What exactly is syndromic testing? The syndromic approach combines a broad grouping of probable pathogens into one quick test. This maximizes the chance of getting an actionable answer in a clinically relevant timeframe.

The syndromic BIOFIRE® FILMARRAY® System is a real-time PCR system that simultaneously isolates, amplifies, and detects the nucleic acids of multiple targets in a single chemical reaction. This entire chemical procedure occurs inside a single pouch that is processed in a BIOFIRE® FILMARRAY® Instrument. The BIOFIRE System then provides automated, user-friendly results for each target.

Outpatient Respiratory Testing  

Many respiratory pathogens cause similar, overlapping symptoms, making it impossible to diagnose respiratory infections based on symptoms alone. And in the wake of the COVID-19 pandemic, patients are naturally worried about any respiratory symptoms and may not be satisfied without a clear diagnosis.

The BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)* takes the syndromic testing approach—it detects 19 relevant respiratory targets, including SARS-CoV-2, influenza, respiratory syncytial virus, and many more, with results in about 45 minutes.

Intended to be used with patients suspected of COVID-19, the BIOFIRE RP2.1-EZ Panel (EUA) runs on the BIOFIRE® FILMARRAY® 2.0 EZ configuration, a real-time PCR system that is authorized for use in outpatient settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Outpatient Gastrointestinal Testing

Infectious gastroenteritis can be caused by many enteric pathogens—but they all cause similar symptoms. Foodborne pathogens, waterborne pathogens, and community-transmitted pathogens can all cause the hallmark symptoms of infectious gastroenteritis: diarrhea, nausea and vomiting, abdominal cramping, and fever. Unfortunately, traditional stool testing and send-out methods are slow and may not offer clear answers, leaving clinicians to make treatment decisions without laboratory results.

Syndromic testing can offer an onsite solution for outpatient providers. The BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel identifies 22 gastrointestinal targets—including bacteria, viruses, and parasites—all in one test, with results in about an hour. The BIOFIRE® GI Panel is designed to be used with the BIOFIRE® FILMARRAY® TORCH in CLIA-moderate settings.

Benefits of Syndromic Testing with the BIOFIRE® System

There are several benefits to offering multiplex PCR testing in an outpatient setting. Syndromic testing delivers the fast, comprehensive, and accurate results that enable timely and targeted treatment decisions—and provide peace of mind for patients. Additionally, the BIOFIRE GI Panel has been shown to reduce unnecessary downstream procedures like CT scans and endoscopies.5

In short, the BIOFIRE System enables outpatient clinics to offer convenient, fast onsite testing, while giving them the answers they need to do what’s best for the patient—all while reducing lengthy and costly send-out tests.

Antimicrobial Stewardship

In addition to helping improve patient satisfaction and supporting clinical decision making, the BIOFIRE System can help reduce the use of unneeded antibiotics.

Respiratory infections are a big culprit when it comes to antibiotic overuse. In fact, just 50% of antibiotic prescriptions for acute respiratory infections were estimated to be appropriate in the outpatient setting.6 The syndromic approach, which provides fast answers on a comprehensive menu, gives clinicians the results they need to make targeted and appropriate treatments decisions. As a result, the first-generation BIOFIRE® FILMARRAY® Respiratory (RP) Panel, in comparison with the standard of care, was shown to result in a decrease in antibiotic prescriptions for 13.6% of adult patients.7

Furthermore, even in a facility with a strong antimicrobial stewardship program, the BIOFIRE® FilmArray® Respiratory EZ (RP EZ) Panel demonstrated a significant improvement in the appropriate use of antimicrobials.4

The BIOFIRE GI Panel similarly has been shown to positively impact patient management decisions: use of the BIOFIRE GI Panel led to 17% more targeted therapy8 than empiric therapy compared with culture and made antibiotic prescriptions 11% less likely.3

The Power of PCR—in Your Facility

Fast, accurate PCR assays may seem out of reach for outpatient clinics. However, the BIOFIRE System was designed for ease of use, with only two minutes of hands-on time required. Onsite PCR testing allows clinicians to give patients answers fast—possibly before the end of their visit. Rapid and comprehensive results may also reduce the need for follow-up visits, and they may facilitate valuable patient/provider conversations about the appropriate use of antimicrobials.

References:

  1. The Advisory Board Company. (2014) Primary Care Consumer Choice Survey. Washington, DC.
  2. Rapid Diagnostic Testing for Influenza: Information for Clinical Laboratory Directors. Accessed 21 Mar 2022. Retrieved from: https://www.cdc.gov/flu/professionals/diagnosis/rapidlab.htm
  3. Guerrant RL et al. Clin Infect Dis. 2001;32:331-351.
  4. Beal S, et al. (2020) Pediatr Infect Dis J. 39(3):188-191.
  5. Axelrad JE, et al. J of Clin. 2019; 27;57(3). e01775-18.
  6. Fleming-Dutra KE, et al. 2016;315(17):1864-1873.
  7. Echavarria J Clin Virol. 2018;108:90–95.
  8. Cybulski R, et al. Clinical Infectious Diseases. 2018;67(11):1688–1696.
  • *This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
  • This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and,
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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