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Respiratory Testing: The Economic Value of the Syndromic Approach


Several respiratory pathogens can cause similar, overlapping symptoms. When a patient has typical cold symptoms, for instance, it’s impossible to know what’s causing the symptoms without diagnostic testing. Is it COVID-19? The flu? Or something else? Instead of serial testing—or send-out testing to confirm negative results—you can get comprehensive and reliable answers the first time with the BIOFIRE® Respiratory Panels.

Look beyond the usual suspects

With a traditional testing approach, clinicians need to choose which respiratory pathogen to test for. COVID-19 testing may be a first choice, followed by influenza. If these tests are negative, additional testing may be required—and at this point, the cost and time involved with serial testing begins to add up.

While COVID-19 and influenza may be top of mind (depending on the season), other respiratory pathogens can be serious as well. For example, every year respiratory syncytial virus (RSV) leads to 58,000 hospitalizations for children younger than 5 and 177,000 hospitalizations for adults 65 and older.1

Adenovirus is another concerning respiratory patnhogen. In the past, the CDC has released a health advisory encouraging clinicians who see pediatric patients experiencing acute hepatitis of unknown etiology to consider testing for adenovirus. This is due to the CDC identifying a cluster of children who had hepatitis, some testing positive for adenovirus.2

On top of all that, while BIOFIRE® Syndromic Trends showed a decrease in all viral respiratory pathogens in the early months of the COVID-19 pandemic, pathogens like RSV, human rhinovirus/enterovirus, and parainfluenza showed a significant percentage of positive detections.3,4 Diagnostics that only test for COVID-19 or influenza may miss these important detections.

Even if the cause is COVID-19 or influenza, rapid tests have lower sensitivity compared with PCR testing. For that reason, the FDA recommends follow-up molecular testing for those who test negative for COVID-19 but are suspected of having COVID-19 due to experiencing symptoms or having recent exposure.5 Follow-up testing can add time and expense to the diagnostic journey.

The Value of the Syndromic Approach

Syndromic testing can overcome the challenges of determining what to test for—and subsequent serial testing. The BIOFIRE® Respiratory 2.1 (RP2.1) Panel takes the syndromic approach, simultaneously testing for 22 respiratory targets in one test, with results in about 45 minutes.

Multiplex PCR testing with the BIOFIRE® RP2.1 Panel provides clinicians with the information they need to make targeted treatment decisions faster. Fast answers on a comprehensive respiratory pathogen panel can also help avoid unnecessary antimicrobials and support patient management decisions around admissions, isolation, and cohorting.

Multiplex PCR testing is both sensitive and specific, giving clinicians confidence in the results. In fact, in its adenovirus health advisory, the CDC recommends PCR testing for detecting adenovirus.2 This confidence may help avoid confirmatory testing for negative results.

Benefits of syndromic testing for outpatient settings

The BIOFIRE® RP2.1 Panel is intended for use in CLIA-moderate settings on the BIOFIRE® FILMARRAY® TORCH or BIOFIRE® FILMARRAY® 2.0 systems. Another version of the panel—the BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)—was designed to be used with the BIOFIRE® FILMARRAY® 2.0 EZ configuration in outpatient settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The BIOFIRE RP2.1-EZ Panel is intended to be used for patients suspected of COVID-19.

The syndromic testing approach offers several benefits when it comes to onsite diagnostic testing. Onsite testing with a comprehensive respiratory pathogen panel may help increase patient satisfaction. Not only is onsite testing more convenient for patients, but testing with the BIOFIRE® RP2.1-EZ Panel (EUA) may provide actionable results by the end of the patient visit—leading to fewer follow-up visits. Furthermore, solid answer can provide peace of mind to patients (and particularly to the worried parents of pediatric patients).

With targets for SARS-Cov-2, influenza, RSV, and several other respiratory pathogens, the BIOFIRE® RP2.1-EZ Panel (EUA) is a valuable option for frontline PCR testing for COVID-19. The BIOFIRE® RP2.1-EZ Panel (EUA) offers fast results in about 45 minutes and features sensitivity of 98.4% for SARS-CoV-2, giving clinicians and patients confidence in negative results.6 And with results on 18 additional respiratory pathogens, patients will be less likely to be left with lingering worries about what’s causing their symptoms.

 

Decreased healthcare expenditures

The fast, accurate results provided by the BIOFIRE® Respiratory Panels may translate into cost savings for healthcare organizations. The original BIOFIRE® FILMARRAY® Respiratory Panel has been shown to:

  • Significantly reduce hospital length of stay7–9
  • Reduce antibiotic duration and decrease unnecessary antibiotic use8
  • Support informed infection control decisions such as shortened isolation times and optimal patient cohorting9

Additionally, comprehensive testing with a respiratory PCR test may help avoid the expense of serial testing and confirmatory testing.

A real-time PCR system

The BIOFIRE® FILMARRAY® System is simple to incorporate into a laboratory’s workflow. The BIOFIRE real-time PCR system can enable greater efficiency by simplifying test ordering and minimizing manual data entry. The BIOFIRE® FILMARRAY® TORCH features a scalable configuration, from two to 12 modules, enabling customized throughput and efficient use of bench space. Based on calculations for the BIOFIRE® RP2.1 Panel, the BIOFIRE® FILMARRAY® TORCH can run up to 351 patient samples each day. BIOFIRE® Respiratory PCR test requires just two minutes technician hands-on time and provides results in about 45 minutes.

The BIOFIRE® Respiratory Panels may help achieve cost savings for your institution. Determining the cost of onboarding and running the BIOFIRE® Respiratory Panels depends on several factors. To get exact pricing information tailored to your institution, request a quote or a free demonstration of the BIOFIRE® System.

 

Contact Our Team

References:

  1. RSV Trends and Surveillance. Accessed 10 May 2022. Retrieved from: https://www.cdc.gov/rsv/research/us-surveillance.html
  2. Recommendations for Adenovirus Testing and Reporting of Children with Acute Hepatitis of Unknown Etiology. Accessed 10 May 2022. Retrieved from: https://emergency.cdc.gov/han/2022/han00462.asp
  3. Nawrocki J, et al. Open Forum Infectious Diseases. 2021;8(7):ofab133.
  4. com
  5. Omicron Variant: Impact on Antigen Diagnostic Tests. Accessed on 28 Feb 2022. Retrieved from: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests?utm_medium=email&utm_source=govdelivery#omicronvariantimpact
  6. Overall performance based on prospective SARS-COV-2 clinical study for the BioFire® Respiratory 2.1 Panel in comparison to 3 EUA tests.
  7. Rappo U, et al. J. Clin. Microbiol. 2016 Aug;54(8):2096-103.
  8. Brendish N, et al. (2017) Lancet Resp Med. 5(5):401.
  9. Shengchen D, et al. Clin. Microbiol. Infect. 2019 Nov;25(11):1415-1421.
  10. Clark TW, et al. Lancet Respir Med. 2020:S2213-2600(20)30469-0.

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