Single PCR Test Simultaneously Detects 12 Respiratory Viruses in Same Patient Sample

By LabMedica International staff writers
Posted on 25 Sep 2024

Image: TAGS technology enables syndromic panel testing on the high throughput molecular diagnostic analyzers cobas 5800, 6800 and 8800 (Photo courtesy of Roche)

Many respiratory illnesses share similar symptoms, making diagnosis challenging. As respiratory outbreaks and antibiotic resistance rise, timely and accurate diagnosis is crucial for providing optimal patient care and preventing transmission. A new test now enables clinicians to identify up to 12 of the most common respiratory viruses, helping to speed up diagnosis and deliver appropriate care.

Roche (Basel, Switzerland) has introduced the cobas Respiratory flex test, the first to utilize the company’s innovative TAGS (Temperature-Activated Generation of Signal) technology. Developed by Roche scientists, TAGS technology combines multiplex polymerase chain reaction (PCR) testing with color, temperature, and data processing to detect up to 15 pathogens in a single test. Traditional PCR tests typically detect only four results in a single test. TAGS technology, however, can differentiate up to three targets per fluorescence channel, allowing the detection of up to 15 diagnostic results from a single kit. This novel, proprietary approach overcomes the limitations of previous 4-plex testing solutions, facilitating syndromic panel testing on the high-throughput cobas 5800, 6800, and 8800 molecular diagnostic analyzers, which is essential when symptoms could be linked to multiple pathogens. Existing cobas 5800, 6800, and 8800 systems can immediately deliver fast, accurate, high-throughput multiplex PCR testing without requiring hardware or software upgrades. Additionally, Roche’s TAGS technology has the potential for broader applications across various pathogens and indications, offering the possibility of transforming high-throughput testing for infectious diseases in the future.

The cobas Respiratory flex test detects up to 12 common respiratory viruses, including influenza A, influenza B, Respiratory Syncytial Virus (RSV), and SARS-CoV-2, from a single patient sample using one PCR test. The test also allows clinicians to select specific pathogens based on factors like the test setting, season, locality, and patient-specific needs. For instance, during winter, a clinician might use the test to determine if a healthy adult patient has influenza or SARS-CoV-2, which are common during that time. Typically, diagnosing a patient requires testing a specific group of pathogens first, which can delay results if follow-up tests are needed. The cobas Respiratory flex test eliminates this delay with its digital reflex feature, enabling immediate generation of additional results without needing a new sample or retesting the original sample. This test delivers comprehensive results from a single PCR, simplifying lab operations and easing logistical challenges, while optimizing resource use. The test is now available in countries that accept CE marking, and several countries have begun their local registration processes. The U.S. FDA 510(k) clearance is expected following submission in Q4.

“Many respiratory illnesses share similar symptoms, making them difficult to diagnose. As respiratory outbreaks, combined with growing incidence of antibiotic resistance continue, getting an accurate and timely diagnosis is critical to providing the best care for patients and curbing transmission,” said Matt Sause, CEO of Roche Diagnostics. “Using TAGS technology, the cobas Respiratory flex test can help clinicians identify specific respiratory viruses sooner, helping to speed up diagnosis and get the right care to patients.”