cobas® Influenza A/B Assay

Give an early, accurate flu 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 by enabling appropriate antiviral prescribing or patient isolation.^2,3

The cobas^® Influenza A/B assay, a multiplex real-time polymerase chain reaction (PCR) test, running on the innovative cobas^® Liat^®System, delivers the speed and reliability needed to determine a timely, accurate diagnosis in ~20 minutes.

cobas^® Influenza A/B performance⁴

Influenza A

LOD: 10^-2 – 10^-1 TCID ₅₀/mL

Sensitivity*

(95% CI: 91.2%-99.3%)

Specificity*

(95% CI: 96.5%-98.7%)

Influenza B

LOD: 10^-3 – 10^-1 TCID ₅₀/mL

Sensitivity**

(95% CI: 84.3%-99.4%)

Specificity**

(95% CI: 96.6%-98.7%)

*Influenza A: Of 15 cobas^® Liat^® System positive, culture negative specimens, 9 were positive and 6 were negative by PCR/sequencing.
Two cobas^® Liat^® System negative, culture positive specimens were positive by PCR/sequencing.

**Influenza B: Of 16 cobas^® Liat^® System positive, culture negative specimens, 14 were positive and 2 were negative by PCR/sequencing.
One cobas^® Liat^® System negative, culture positive specimen was positive by PCR/sequencing and was negative by lab-based RT-PCR.

CI=confidence intervals. LOD=limit of detection. TCID=tissue culture infective dose.

The cobas^® Liat^® PCR System vs. conventional methods

Multi-test

algorithm

Patient suspected of influenza

Specimen collected to perform a
rapid antigen test

Negative result needs confirmation

Samples sent to the lab for PCR batch testing (4-24 hours)

Patient less likely to benefit from antiviral treatment started >48 hours after symptom onset⁵

cobas^® Influenza
A/B test

Patient suspected of influenza

Specimen collected

Perform cobas^® Influenza A/B Test
(Definitive results in 20 minutes)

cobas^® Liat^® System

Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

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Intended use

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

Registration status

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

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.

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

Respiratory tract infections

The non-specific clinical presentation of respiratory infections poses a considerable challenge to the differential diagnosis of pathogens. What impact can a timely and accurate diagnosis have on patient management?

Healthcare-associated infections (HAIs)

From prolonging institutional stays to creating long-term disability, healthcare-associated infections place a tremendous financial burden on health systems.

Antibiotic resistance and diagnostic testing

As mankind continues its widespread use of antibiotics, antimicrobial resistance will continue to pose a threat to the global healthcare system.

References

World Health Organization. Vaccines against influenza. WHO position paper – November 2012 Weekly Epidemiol Record. 2012;87(47):461–76.
KA Stellrecht, et al. J Clin Virol. 2017;93:25-29.
Hansen GT, et al. J Clin Virol. 2018;102:42-49.
cobas^® Influenza A/B [package insert]. Pleasanton, CA: Roche Molecular Systems, Inc., 2015.
Centers for Disease Control and Prevention. Use of antivirals. http://www.cdc.gov/flu/professionals/antivirals/antiviral-use-influenza.htm. Accessed April 20, 2017.