cobas^® Liat^® PCR System

We put a lab in a tube

SARS-CoV-2¹, SARS-CoV-2 & Influenza A/B¹, Influenza A/B & RSV, Group A Strep, and C. Difficile^2*

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 SARS-CoV-2¹, SARS-CoV-2 & Influenza A/B¹, Influenza A/B & RSV, Group A Strep, and C. Difficile² — 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.

Testing Accuracy

With real-time PCR technology

Definitive Results

No need for interpretation.

Fast, Easy Operation

3 easy steps; 15 to 20 minutes, depending on the assay.

Have any questions?

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 patient samples
High sensitivity and specificity across assays 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).}

Test Before You Treat

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

The cobas Liat System - Working Principle

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Registration status

IVD

References

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
This product has been approved by FDA for use by authorized laboratories certified under CLIA to perform moderate complexity testing.

Technical Specifications

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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
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® SARS CoV-2¹	09211101190
cobas® SARS CoV-2 & Influenza A/B¹	09408592190
cobas® Strep A	07341911190
cobas® Influenza A/B & RSV	08160104190
cobas® C. Difficile²	07454945190

References

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
This product has been approved by FDA for use by authorized laboratories certified under CLIA to perform moderate complexity testing.

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.

SARS-CoV-2¹

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SARS-CoV-2¹ assay performance
	Positive Agreement	Negative Agreement	LoD
Symptomatic Individuals	96.1%	96.8%	2.4 x 10^-2 TCID₅₀/mL (24 copies/mL)
Asymptomatic Individuals	100%	98.9%	1.2 x 10^-2 TCID₅₀/mL

The cobas^® SARS-CoV-2 Nucleic acid test for use on the cobas^® Liat^® System (cobas^®SARS-CoV-2) is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of nucleic acid from SARS-CoV-2 in self-collected anterior nasal (nasal) swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal, mid-turbinate and anterior nasal (nasal) swabs from either individuals suspected of COVID-19 by their healthcare provider or from any individual, including individuals without symptoms or other reasons to suspect COVID-19. Package Insert Package Insert cobas^® Liat^® SARS-CoV-2.

SARS-CoV-2 & Influenza A/B¹

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SARS-CoV-2 & Influenza A/B¹ assay performance
	Positive Agreement	Negative Agreement	LoD
SARS	100%	100%	1 x 10^-2 TCID₅₀/mL (12 copies/mL)
Flu A	98.4%	96.5%	2 x 10^-3 – 2 x 10^-2 TCID₅₀/mL
Flu B	97.9%	99.4%	2 x 10^-3 – 4 x 10^-3 TCID₅₀/mL

The cobas^® SARS-CoV-2 & Influenza A/B Nucleic acid tests for use on the cobas^® Liat^® System (cobas^® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and B virus RNA in healthcare provider-collected nasopharyngeal and nasal swabs, and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Package Insert cobas^® Liat^® SARS-CoV-2 & Influenza A/B.

Strep A

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cobas® Strep A Assay 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 & RSV

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cobas® Influenza A/B & RSV Assay 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

C. Difficile²

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C. Difficile² Assay Performance
Sensitivity vs. direct culture	Specificity vs. culture	LoD
94.6%	96.2%	90 CFU/swab

The cobas^® Cdiff Nucleic acid test for use on the cobas^® Liat^® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas^® Cdiff Nucleic acid test for use on the cobas^® Liat^® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors. Package Insert cobas^® Liat^® C. Difficile.

References

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
This product has been approved by FDA for use by authorized laboratories certified under CLIA to perform moderate complexity testing.

cobas® Liat® PCR System

We put a lab in a tube

SARS-CoV-21, SARS-CoV-2 & Influenza A/B1, Influenza A/B & RSV, Group A Strep, and C. Difficile2*

Registration status

Related information

Related Assays

cobas^® Liat^® PCR System

SARS-CoV-2¹, SARS-CoV-2 & Influenza A/B¹, Influenza A/B & RSV, Group A Strep, and C. Difficile^2*