cobas® liat SARS-CoV-2, Influenza A/B & RSV*

Country Specific Labeling See country-specific product labeling for regulatory status.
cobas SARS-CoV-2, Influenza A/B and RSV Nucleic Acid Test

Use left and right arrow keys to scroll between the tabs

One visit. One Test. Multiple Results.

The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay uses Nobel Prize-winning PCR technology to detect and differentiate SARS-CoV-2, influenza A, influenza B and RSV from a single patient sample in just 20 minutes. 

The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay is authorized for use in CLIA-waived settings, has no age restrictions and requires less than 1 minute of hands-on time, providing quick, accurate results to support timely clinical decisions. 

When symptoms of COVID-19, influenza and RSV look the same, it may be difficult to quickly and accurately diagnose infection based on signs and symptoms alone.  The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay helps streamline testing and enables confident treatment decisions when and where it’s needed the most.

cobas® SARS-CoV-2, Influenza A/B & RSV specifications

View Full Table

cobas® SARS-CoV-2, Influenza A/B & RSV specifications

Instrument

cobas® liat system

Targets

SARS-CoV-2, Influenza A/B, RSV

Registration

Emergency Use Authorization (EUA); Authorized for use in CLIA-Waived settings

Time to result

~20 minutes

Sample type

Nasopharyngeal swab, nasal swab

Reagents

Ready-to-use, pre-packed tube format

Kit Storage

2–8°C

Collection media

Universal Transport Media (UTM), 0.9% saline

Technology

Real-time PCR

Sample extraction

Fully automated and integrated

Control

Internal sample processing control, positive and negative controls

cobas® SARS-CoV-2, Influenza A/B & RSV ordering information

View Full Table

cobas® SARS-CoV-2, Influenza A/B & RSV ordering information

Material Number

Alternative Catalog Number

Material Description

Pack Size

Pack size Description

09731261190   KIT C LIAT SARS COV2 FLU AB RSV 1 pack 20 tests
09731270190   C LIAT SARS COV2 FLU AB RSV QC 1 pack 3 sets
<b>cobas</b><sup>®</sup> SARS-CoV-2, Influenza A/B & RSV intended use<sup>1</sup>

cobas® SARS-CoV-2, Influenza A/B & RSV intended use1

The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. 

Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens  during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas® liat system and the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Learn more about the cobas® liat SARS-CoV-2, Influenza A/B & RSV Assay

Please submit your information in the following form to be contacted by a Roche representative with more details.

Reference

  1. cobas® SARS-CoV-2, Influenza A/B and RSV Package Insert, Pleasanton, CA, Roche Molecular Systems Inc.

 

*Disclaimer

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 certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform high, moderate or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and RSV, not for any other viruses or pathogens.

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.

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later