COVID-19: Two Years Later
The world is now more than two years past the initial outbreak of the COVID-19 pandemic, and it’s incredible how much the COVID testing landscape has changed in those two years. In the early days, testing supply shortages made it difficult for communities to quickly scale testing operations, causing long lines—and a concerning inability to accurately track the progress of the pandemic.
But governments and private industry made heroic efforts to create and deploy novel COVID testing options. Here at bioMérieux, researchers and scientists developed the BIOFIRE® Respiratory 2.1 (RP2.1) Panel—and received FDA emergency use authorization—within just 40 working days. The syndromic BIOFIRE RP2.1 Panel added targets for SARS-CoV-2 into an already broad respiratory pathogen panel.
In March 2021, the BIOFIRE RP2.1 Panel became the first COVID-19 test to receive authorization outside the FDA EUA pathway.
These days, many testing options are available to labs and the general public. But not all tests are created equal. And the resurgence of other respiratory pathogens emphasizes the utility of the syndromic approach to COVID-19 testing.
Rapid antigen vs. PCR testing
Often, COVID testing utilizes rapid antigen tests, which detect a protein that’s associated with SARS-CoV-2. At-home COVID tests are also antigen tests. These tests are generally less accurate than polymerase chain reaction (PCR) tests.
For example, in one study, the Utah Department of Health found that more than 50% of people who tested positive with PCR testing for COVID-19 simultaneously tested negative with a rapid antigen test.1 Furthermore, the FDA has cautioned that rapid antigen tests may have even further reduced sensitivity for detecting the Omicron variant.2
Due to this reduced sensitivity, the FDA recommends that if a person is suspected of having COVID-19 but tests negative with a rapid antigen test, they should have follow-up confirmatory molecular testing.2
Molecular PCR tests work differently from antigen tests. PCR COVID tests isolate, amplify, and detect the DNA of SARS-CoV-2. The BIOFIRE RP2.1 Panel has a sensitivity of 98.4% for the SARS-CoV-2 target,3 meaning that if the result is negative, there is only a very small chance it’s a false negative.
Value of the syndromic approach
While COVID-19 has been the dominant respiratory concern, it is only one of many respiratory illnesses that present with very similar symptoms. A negative COVID test may leave patients and their providers wondering what exactly is causing concerning symptoms.
The BIOFIRE RP2.1 Panel takes the syndromic testing approach, providing answers on a respiratory panel of 22 possible pathogens, including SARS-CoV-2, influenza, respiratory syncytial virus, and more. Multiplex PCR testing with a comprehensive respiratory pathogen panel increases the probability of getting an answer in a clinically relevant timeframe. Syndromic testing with the BIOFIRE RP2.1 Panel may also help detect co-infections. Roughly 20% of COVID-19 patients had co-infections with another respiratory pathogen, according to one study.4
The impact of multiplex PCR COVID testing
Fast, comprehensive results on a syndromic respiratory panel can give clinicians the information they need to make crucial therapy and patient-management decisions. Knowing the probable pathogen is a virus, for example, helps clinicians have valuable conversations with their patients about the inefficacy of antibiotics for viral infections. This contributes to the avoidance of unnecessary antibiotics, supporting antimicrobial stewardship goals. Additionally, an early influenza diagnosis allows patients to begin antiviral therapy within the timeframe of efficacy.
Fast, multiplex PCR testing for COVID-19 can also help emergency room and critical care providers make patient-management decisions surrounding admission, discharge, isolation, and cohorting.
The BIOFIRE PCR System
The BIOFIRE® FILMARRAY® System tests at the molecular level to provides fast, comprehensive, and accurate results. This rapid PCR system is easy to use and requires just two-minutes of hands-on time.
The BIOFIRE® FilmArray® Torch can be used in CLIA-moderate settings, while the BIOFIRE® FilmArray® 2.0 EZ configuration is authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)* is intended to be used with the BIOFIRE 2.0 EZ system configuration for patients suspected of COVID-19. This respiratory panel includes SARS-CoV-2, along with 18 additional respiratory pathogens, for a front-line COVID-19 solution.
Explore syndromic testing and COVID-19
References:
- UDOH. UDOH to temporarily pause use of on-site rapid tests at state testing sites. Accessed on 28 Feb 2022. Retrieved from: https://health.utah.gov/featured-news/udoh-to-temporarily-pause-use-of-on-site-rapid-tests-at-state-testing-sites
- FDA. 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
- Overall performance based on prospective SARS-COV-2 clinical study for the BioFire® Respiratory 2.1 Panel in comparison to 3 EUA tests, Data on file, BioFire Diagnostics.
- Kim D, et al. (2020) JAMA. 323(20):2085-2086.
- *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.
