cobas^® Influenza A/B Assay

Given an early, accurate influenza diagnosis

Influenza affects 5-10% of adults and 20-30% of children each year.¹ Whether it’s a typical flu season, or a worst-case pandemic, testing and screening for influenza A and B can help protect patients.

Get the speed and reliability you need to support a timely, accurate diagnosis with the cobas^® Influenza A/B assay. A multi-plex real-time PCR assay, cobas^® Influenza A/B differentially detects both influenza A and influenza B in ~20 minutes.

cobas^{^®} Influenza A/B performance

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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

Intended use

cobas® Influenza A/B Nucleic acid test

The cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System, 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.

The cobas® Liat® System is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

Registration status

CE-IVD, FDA 510(k) cleared, CLIA waived

References

eferences

World Health Organization. Vaccines against influenza. WHO position paper – November 2012 Weekly Epidemiol Record. 2012;87(47):461–76.

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