The Value of Syndromic Respiratory Testing in Outpatient Settings

A 41-year-old female with an unremarkable medical history enters the ED complaining of fatigue. She's been feeling this way for four days and suspects that she may have been exposed to COVID-19. Upon completing her physical, clinicians get the impression that she may, indeed, be infected with a virus, potentially even COVID-19.

However, after running the BIOFIRE^® Respiratory 2.1 Panel, the doctors confirm that the patient has an upper respiratory tract infection (URTI), but also that the infection is bacterial rather than viral in nature. Specifically, the pathogen is Bordetella pertussis, which is commonly associated with the highly contagious whooping cough.

The patient is given the appropriate antibiotic treatment and makes a full recovery. But what might have happened if the ED doctors went off their initial impression of viral infection?

The importance of differential diagnosis in the era of COVID-19

We've all felt the symptoms at some point: coughing, fatigue, sore throat, stuffy nose, fever/chills.

But does this mean we had the flu, SARS-CoV-2, common cold, or something more?

Upper respiratory tract infections remain a challenge to diagnose. This is especially felt in outpatient settings, where URTIs have and will continue to carry a significant burden. Influenza alone accounts for around 14.5 million annual outpatient office visits,¹ while respiratory symptoms remain among the top complaints among urgent care patients.²

As in previous years, influenza and SARS-CoV-2 are taking center stage this respiratory season. However, other serious respiratory pathogens continue to circulate nationwide, with rhinovirus/enterovirus taking up the largest share of cases (as was the case pre-pandemic).³

The clinical significance of overlooked viral and bacterial respiratory infections cannot be overstated. For example, the long-term consequences of undiagnosed adenovirus include acute bronchitis and bronchiolitis, while Bordetella pertussis can lead to pneumonia, apnea, seizures, brain damage, or even death in infants and other at-risk groups.^4,5

Diagnosis via the assessment of symptomology is not enough; instead, multiplex PCR testing can accurately confirm COVID-19 and other upper respiratory tract infections, as well as critical cases of co-infection.

The Syndromic Approach to Respiratory Testing

With traditional testing, diagnosing URTIs is a guessing game. Will the right test be ordered? Will additional tests need to be ordered—and which ones? Will results be available in time to impact treatment decisions? Without solid answers, patient care may be compromised, increasing the risk of adverse outcomes and patient dissatisfaction.

Syndromic testing serves to allay any doubt when it comes to respiratory diagnostics so that clinicians can confidently make informed therapy decisions. With fast answers on a comprehensive menu, syndromic testing increases the chance of identifying a pathogen. This, in turn, may reduce additional testing, inform therapy decisions and antibiotic stewardship efforts, and aid in patient management decisions such as admission, isolation, and cohorting.

In other words, the syndromic approach means using the right test, the first time to help outpatient clinics:

Improve diagnostic yield compared to rapid antigen tests⁶
Better use healthcare resources⁷
Support antibiotic stewardship⁸
Potentially reduce unnecessary or ancillary testing
Potentially increase confidence to make a definitive diagnosis
Improve patient management⁶

Syndromic Testing with the BIOFIRE® Respiratory (RP) Panels

The BIOFIRE^® Respiratory 2.1 (RP2.1) Panel and the BIOFIRE^® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)* are designed with syndromic testing in mind. Both are PCR-based qualitative multiplexed in vitro diagnostic tests that are capable of simultaneous detection and identification of multiple bacteria and viruses.

The BIOFIRE RP Panels produce a single report on a broad respiratory pathogen menu within about 45 minutes, empowering outpatient clinics to perform diagnostics, including COVID-19 and influenza testing, quickly and efficiently.

The BIOFIRE RP2.1 Panel

The BIOFIRE RP2.1 Panel provides simultaneous detection of 22 respiratory tract pathogens, including 18 viruses and 4 bacteria responsible for COVID-19, pneumonia, influenza, the common cold, whooping cough, and more.

The BIOFIRE RP2.1 Panel is intended to be run on the BIOFIRE^® FILMARRAY^® TORCH and BIOFIRE^® FILMARRAY^® 2.0 systems in CLIA-moderate settings.

The BIOFIRE RP2.1-EZ Panel (EUA)*

The BIOFIRE RP2.1-EZ Panel (EUA)* detects SARS-CoV-2, along with 14 additional viruses and 4 bacteria in patients suspected of COVID-19 infection. This respiratory PCR test provides results in about 45 minutes, which gives clinicians the ability to give patients the right treatment the first time, potentially leading to shorter appointment times and improved antimicrobial stewardship.

The BIOFIRE RP2.1-EZ Panel (EUA)* is designed to run on the BIOFIRE^® FILMARRAY^® 2.0 EZ Configuration System, which is intended to be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Benefits to your clinic

Clinical	Operational
Potentially improve the use of healthcare resources⁷ Improve diagnostic yield⁶ Offer pathogen-directed, timely, and effective therapy (antimicrobial stewardship)⁶	May help to avoid unnecessary testing May provide comprehensive answers in a clinically actionable timeframe Reduce appointment duration6Potentially improve patient management⁷

Bottom Line

As with every respiratory season, respiratory infection cases will skyrocket, and outpatient clinics will face an increased volume of patient testing. With the heightened prevalence of respiratory co-infections and clinical risks associated with missed diagnoses, the BIOFIRE Respiratory Panels can provide clinicians with fast, comprehensive answers and take the guesswork out of choosing which pathogens to test for, thereby empowering outpatient clinicians to administer prompt therapy to patients when they need it most.

References

Matias G, et al. BMC Infectious Disease 2016;16:641.
JUCM Chart Audit Research p. 19.
BIOFIRE^® Syndromic Trends. Accessed 22 Sept. 2022 Retrieved from: https://syndromictrends.com/
Differential Diagnosis of Unexplained Respiratory Outbreaks (URDO). Accessed 22 Sept. 2022
Germ School, Intermountain Healthcare. Accessed 22 Sept. 2022 Retrieved from: https://intermountainhealthcare.org/health-information/germwatch/germ-school/bordetella-pertussis/
Beal SG, et al. Pediatr. Dis. J. 2020;39(3):188-191.
Fenton, J, et al. Pediatr, Infect. Dis. J. 2020;39:9:p e282-e283.
Kitano T, et al. (2020) J Infect Chem. 26(1):82-85.

*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.