cobas® Liat® PCR System

RMD_cobas_liat_system

We put a lab in a tube

 

Influenza A/B - Influenza A/B & RSV - Group A Strep

When there is a pressing need for a diagnosis and a treatment decision, patients rely on
you and your staff for the most responsive, trustworthy medical attention available.

The cobas Liat PCR System allows you to detect and identify Influenza A/B, Influenza
A/B & RSV and Strep A — in your own clinic, using gold-standard PCR technology
previously available only in complex molecular laboratories.

The cobas Liat PCR System is small, easy to use and fast—able to provide accurate results by
the end of a patient’s appointment.

The cobas Liat System is on-site molecular testing you can depend on.
For the patients who depend on you.

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Unparalleled accuracy in diagnostic testing

. . . now at physicians' fingertips

Roche has pioneered the advancement of polymerase chain reaction (PCR) analysis, now recognized as a gold standard in laboratory diagnostics.

  • Proprietary, Nobel Prize-winning technology
  • Identifies infectious diseases by replicating DNA or RNA extracted from small patient samples
  • High sensitivity and specificity across assays significantly reduces the risk of false negatives and false positives

 

Recognized as one of the most important scientific advances of the 20th century1, polymerase chain reaction (PCR) is a quick, easy way to create unlimited copies of DNA or RNA from just one original strand.

1. Mark R. Hughes, deputy director of the National Center for Human Genome Research at the National Institutes of Health (perhaps better known as the Human Genome Project).

 

 

The cobas Liat PCR System for results-oriented patient care

In large molecular laboratories, PCR analysis can be performed on many samples simultaneously—a multi-step process requiring a skilled technician.

The cobas Liat System fully automates these steps for the rapid analysis of a single sample, making it ideal for time-sensitive in-office diagnoses.

No operator intervention or interpretation required.

  • Each cobas Liat assay tube contains a set of chemical reagents used in the detection of DNA or RNA sequences unique to a particular infectious disease
  • Inside the cobas Liat Analyzer, pressure and heat are precisely applied to the tube segments, mixing the sample and reagents in a prescribed sequence
  • DNA or RNA from within the sample is amplified and analyzed to detect and identify disease
  • An accurate positive or negative result is generated in 20 minutes or less
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Registration status

IVD

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Technical Specifications

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Technical Specifications

Power supply
Input 100-240V AC /50-60Hz
Output 15V DC / 8.6A
Environmental requirements (operating)
Temperature +15°C to +32°C
Relative humidity 15% to 80% (non-condensing)
Maximum altitude 2,000 m (6,500 ft.) above sea level
Dimensions and weight
Height 19.0 cm (7.5")
Width 11.4 cm (4.5")
Length 24.1 cm (9.5")
Weight 3.76 kg (8.3 lbs.)
Data and display
Up to 20,000 records can be stored, backed up and archived
HL7 enabled connectivity
PCR curve display
Barcode types supported
Codabar
Code 39
Code 93
Code 128
EAN-8
EAN-13
GS1-DataBar
Interleaved 2 of 5
Ordering information
cobas® Liat Analyzer 07341920190
cobas® Influenza A/B 07341890190
cobas® Strep A 07341911190
cobas® Influenza A/B & RSV 08160104190
Assay Menu

With a broad menu of assays in development and the long-term commitment of Roche Molecular Diagnostics, the cobas Liat System can help you respond to time-sensitive patient care needs.

 

Strep A

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Strep A

Accurate results, no confirmation needed

cobas® Strep A Performance
Sensitivity Specificity LOD
98.3% 94.2% 5–20 CFU/mL
With high sensitivity, cobas Strep A provides the reassurance needed when prescribing antibiotic treatment. FDA 510(k) cleared and CLIA waived. Intended use for cobas® Strep A1 The cobas® Strep A nucleic acid test for use on the cobas Liat System (cobas® Liat Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The cobas® Liat Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. 1. Package insert cobas® Strep A, Rev. 4, 07806124190-02EN.

Influenza A/B

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Influenza A/B

Comprehensive strain coverage

cobas® Influenza A/B Performance
Performance Influenza A Influenza B
Sensitivity 100% 100%
Specificity 96.8% 94.1%
LOD 10-2 – 10-1 TCID50/mL 10-3 – 10-1 TCID50/mL
With high sensitivity, cobas Influenza A/B provides the reassurance needed when prescribing antiviral treatment. FDA 510(k) cleared and CLIA waived. Intended use for cobas® Influenza A/B1 The cobas® Influenza A/B nucleic acid test for use on the cobas® Liat System (cobas® Liat Influenza A/B) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of Influenza A and Influenza B in humans and is not intended to detect Influenza C. 1. Package insert cobas® Influenza A/B, Rev. 8

Influenza A/B & RSV

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Influenza A/B & RSV

1 sample, 1 test, 3 results and 0 age restrictions


cobas® Influenza A/B & RSV Performance
  Positive Agreement
Negative Agreement
Influenza A 98.3% 96.0%
Influenza B 95.2% 99.4%
RSV 97.0%* 98.7%
*Compared to an FDA-cleared laboratory based multiplexed real-time reverse transcription PCR (RT-PCR) test; cobas® Influenza A/B & RSV [package insert]. With extraordinary sensitivity, cobas Influenza A/B & RSV provides the reassurance needed when prescribing antiviral treatment. FDA 510(k) cleared and CLIA waived. Intended use for cobas® Influenza A/B & RSV1 The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat® System (cobas® Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. 1. Package insert cobas® Influenza A/B & RSV, Rev. 1