New high-throughput panel uses advanced PCR signal detection to enable customizable respiratory virus testing from a single sample.
Roche announced US Food and Drug Administration 510(k) clearance for the cobas Respiratory 4-flex, a test that provides PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV).
This assay utilizes Roche’s TAGS (temperature-activated generation of signal) technology, designed to streamline respiratory testing and ensure timely and accurate patient diagnoses. Developed by Roche scientists, TAGS technology uses multiplex polymerase chain reaction testing, combined with color, temperature, and data processing, to enable the detection and differentiation of multiple targets within a single optical channel. It integrates with Roche’s cobas 5800, 6800, and 8800 molecular lab instruments.
“The cobas Respiratory 4-flex assay offers a significant technological advancement that empowers labs to address evolving respiratory testing demands now and in the future,” says Brad Moore, president and CEO of Roche Diagnostics North America, in a release. “The expanded testing capabilities, enabled by TAGS technology, will allow labs to deliver reliable and relevant patient testing, while also optimizing healthcare resources.”
Customizable Testing for Diagnostic Flexibility
With a customizable testing menu, cobas Respiratory 4-flex enables laboratories to tailor testing to physician orders and patient needs. The test includes a “digital reflex” option, which allows for additional testing from the same sample. For example, if the physician requests influenza A and B and the results are negative, a digital reflex can request results for SARS-CoV-2 or RSV, focusing on relevant tests for the patient. While raw data for all targets is generated and available, only requested results are analyzed and reported.
“Our goal for the Respiratory 4-flex is to allow labs to customize testing based on clinical needs, patient symptoms, which are often similar, and to better support a constantly shifting respiratory landscape,” says Denise Heaney, PhD, chief medical partner, molecular solutions and infectious disease at Roche Diagnostics, in a release. “TAGS technology allows for the detection of more targets on a high-throughput platform, which supports diagnostic stewardship while reaching a broader patient population.”
Photo caption: The cobas Respiratory 4-flex runs on the cobas 5800, 6800, and 8800 systems. The test offers detection and differentiation of SARS-CoV-2, influenza A and B, and RSV in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection, along with clinical and epidemiological risk factors.
Photo credit: Roche
