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Four-In-One Molecular Test Detects and Differentiates Among Most Prevalent Respiratory Viruses in 20 Minutes

By LabMedica International staff writers
Posted on 13 Jun 2024

The U.S. Centers for Disease Control and Prevention (CDC) has reported that respiratory diseases in the United States reached high levels during the recent autumn and winter seasons, with SARS-CoV-2 leading to the most emergency department visits. Hospitalizations for respiratory illnesses have put a significant strain on hospitals, potentially delaying diagnoses and treatments for other patients. During the 2023-2024 respiratory season, the highest rates of emergency department visits and hospitalizations due to SARS-CoV-2, influenza, and RSV were observed in infants, children, and adults aged 65 and older. Nationally, the proportion of deaths recently attributed to these respiratory viruses was highest among patients aged 65 and older. Diagnostics are crucial in combating respiratory diseases. Now, a new diagnostic test employs sensitive polymerase chain reaction (PCR) technology and requires just a single nasal swab sample to quickly and accurately identify and differentiate among four major respiratory viruses, guiding appropriate treatment decisions.

Developed by Roche (Basel, Switzerland), the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated, multiplex, real-time polymerase chain reaction (RT-PCR) assay that delivers results within 20 minutes. The test is performed on the compact cobas liat analyzer, making it suitable for a wide range of healthcare environments. It uses either a single nasopharyngeal or anterior nasal swab sample to confirm or rule out infections with SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). This test is specifically designed for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and RSV in nasal and nasopharyngeal swab specimens from individuals exhibiting symptoms of respiratory tract infections consistent with COVID-19 as assessed by their healthcare provider. The clinical symptoms of respiratory viral infections from SARS-CoV-2, influenza, and RSV are often similar, highlighting the need for precise diagnostics.


Image: The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test runs on the cobas liat system (Photo courtesy of Roche)
Image: The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test runs on the cobas liat system (Photo courtesy of Roche)

The cobas liat system integrates the cobas liat analyzer—an automated nucleic acid testing instrument—with cobas liat assay tubes to fully automate the testing process. This integration simplifies workflows and enables healthcare professionals to conduct molecular testing in various near-patient settings efficiently, reliably, and with minimal training. The system manages all steps including reagent preparation, target enrichment, inhibitor removal, nucleic acid amplification, PCR amplification, real-time detection, and result interpretation, automating the detection and quantification of nucleic acid targets within a biological sample in a single, closed tube. Results are produced in 20 minutes or less, assisting in swift patient care decisions. The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval.

“We are proud to provide this innovative test to address the significant burden placed on healthcare systems,” said Matt Sause, CEO of Roche Diagnostics. “Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

 


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