For in vitro diagnostic use. Others cobas Respiratory flex IVD cobas® Respiratory flex PID00000771 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 623 701 190 9 623 701 190 09623701190 9623701190 09623701190 KIT COBAS 58/68/8800 RESP FLEX 192T IVD KIT COBAS 58/68/8800 RESP FLEX 192T IVD 00875197007312 Reagents, kits 1 kit 192 tests true cobas® Respiratory flex for use on the cobas® 5800/6800/8800 systems (cobas® Respiratory flex) is an automated, multiplex, nucleic acid test that utilizes real-time polymerase chain reaction (PCR) technology for simultaneous in vitro qualitative detection and differentiation of adenovirus (species B, C and E), common human coronaviruses (229E, HKU1, NL63, OC43), human metapneumovirus, human rhinovirus/enterovirus, influenza A virus, influenza B virus, parainfluenza viruses 1, 2, 3, and 4, respiratory syncytial virus (RSV), and SARS-CoV-2 in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections in conjunction with clinical and epidemiological risk factors. The detection and identification of specific viral nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. Negative results do not preclude a respiratory infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out coinfection with other organisms, and the agent detected may not be the definite cause of disease. Due to the genetic similarity between human rhinovirus and enterovirus, the cobas® Respiratory flex test cannot reliably differentiate them. en cobas® Respiratory flex is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 System is designed as one integrated instrument. The cobas® 6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 system or cobas® 6800/8800 systems software(s), which assigns results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Nucleic acid from patient samples and added Internal Control RNA (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way. Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers detecting conserved viral genome regions. Targeted Target gene (symbol) Influenza A Matrix protein 1 (M1) Influenza B Non-structural protein NS-1/2 (NS1/NEP) Respiratory Syncytial Virus Matrix protein (M) SARS-CoV-2 ORF1 ab polyprotein (ORF1ab) and ORF 1a polyprotein (ORF1a) Adenovirus B/E Terminal protein precursor (E2B) Adenovirus C Capsid protein precursor (L3) Human Metapneumovirus Matrix protein (M) Enterovirus/Rhinovirus 5’ untranslated region (5’UTR) Coronavirus OC43 Replicase polyprotein 1 a/b (ORF1ab Coronavirus HKU1 Replicase polyprotein 1 a/b (ORF1ab) Coronavirus 229E Replicase polyprotein 1 a/b (ORF1ab) Coronavirus NL63 Replicase polyprotein 1 a/b (ORF1ab) Human Parainfluenza Virus 1 L polymerase protein (L) Human Parainfluenza Virus 2 Large protein (L) Human Parainfluenza Virus 3 Nucleocapsid protein (N) Human Parainfluenza Virus 4 Large protein (L) Selective amplification of RNA IC is achieved by the use of non-competitive, sequence specific forward and reverse primers, which have no homology with the viral-target specific genomes. Amplified target is detected by the cleavage of fluorescently labeled oligonucleotide probes. Roche’s temperature assisted generation of signal (TAGS) technology, short TAGS technology, is introduced to differentiate up to three targets per fluorescence channel, enabling the detection of 12 targets, and the Internal Control, per well. A thermostable DNA polymerase enzyme is used for amplification. The cobas® Respiratory flex master mix contains detection probes which are specific for adenovirus (species B,C and E), common human coronaviruses (229E, HKU1, NL63, OC43), human metapneumovirus, human rhinovirus/enterovirus, influenza A virus, influenza B virus, parainfluenza viruses 1, 2, 3, and 4, RSV, and SARS-CoV-2, and the RNA Internal Control nucleic acid. Multiplicity of target detection is enabled with temperature-dependent quenching of cleaved fluorescent target-specific probes. This is achieved by separating signals from probes into introduced thermal channels, where fluorescence is acquired at two additional fixed temperatures for each amplification cycle. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase, resulting in separation of the reporter and quencher dyes, and the generation of a fluorescent signal. Conventional probes release fluorescence signal immediately upon separation of reporter from quencher. TAGS probes rely on temperature dependent fluorescence activation, requiring both nuclease cleavage during the extension phase, as well as an increase in reaction temperature, to activate the otherwise dormant fluorophore. For this reason, during each PCR cycle the test captures fluorescence in five available fluorescence channels in combination with three thermal channels (detection of fluorescence at three defined temperatures T1 T2 and T3), which enables simultaneous detection and differentiation of the amplified adenovirus (species B,C and E), common human coronaviruses (229E, HKU1, NL63, OC43), human metapneumovirus, human rhinovirus/enterovirus, influenza A virus, influenza B virus, parainfluenza viruses 1, 2, 3, and 4, RSV, and SARS-CoV-2 viral targets and the RNA IC. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythymidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first thermal cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. en

cobas^® Respiratory flex

Qualitative nucleic acid test for use on the cobas^® 5800/6800/8800 systems

IVD

Centralized syndromic PCR testing with the flexibility to test just what is relevant and needed

cobas® Respiratory flex for use on the cobas® 5800/6800/8800 systems is an automated, multiplex nucleic acid test that utilizes real-time polymerase chain reaction (PCR) and temperature activation of signal (TAGS) technology for simultaneous in vitro qualitative detection and differentiation of up to 12 viral results.

cobas Respiratory flex gives labs the flexibility to tailor and test just what’s needed. Existing cobas 5800/6800/8800 systems are ready right now without any system hardware or system software upgrade required. Labs can now simplify respiratory testing logistics by offering a customizable solution out of one test kit.

Gold standard PCR testing for quick and accurate identification of respiratory infections

Acute respiratory tract infections are significant causes of worldwide morbidity and mortality.^1-5 Many acute respiratory illnesses present with similar symptoms, and because different types of treatment are available for some, it’s important to quickly identify the viral pathogen causing symptoms. Quick and accurate identification can lead to proper treatment within an effective time frame and help prevent further transmission.

From an accuracy standpoint, PCR is the gold standard. Beyond accuracy, which viral pathogens need to be tested often depends on a number of variables. Many institutions or labs define a testing algorithm where specific targets get tested first, then follow up testing occurs for certain patients based on initial results. To meet the requirements of their algorithm, many labs utilize a mix of single target (focused) tests and multiplex tests on a variety of platforms. This can result in duplicate testing, extra turnaround time and/or the need for additional patient samples which can delay treatment and impact patient care and costs.

Benefits at a glance

Multiply the PCR power of your current instrument with TAGS

cobas Respiratory flex is Roche’s first test to leverage TAGS technology.

Our industry-defining Temperature Activated Generation of Signal (TAGS) technology delivers more targets
5 optical channels to differentiate the PCR reaction signal and 3 temperature-specific channels for higher multiplex, with up to 15 differentiated targets
TAGS works within the existing technology of the cobas 5800/6800/8800 systems without hardware or software changes
Up to 12 viral results provided with cobas Respiratory flex

Flexibility to test only what you need

Select targets and receive additional results, all from the kit within the same test run.

Get definitive PCR results for 12 of the most common viral respiratory infections
Similar time to results as other tests on your cobas 5800/6800/8800 systems
Choose which targets to run and get additional results through digital reflex, triggered by the initial findings
Customize your assay based on variables that impact what is needed, such as test setting, seasonality, local dynamics, and patient segments
In just one kit, confidently and quickly learn all that is medically relevant and necessary

Simplify lab logistics with a customizable solution

cobas Respiratory flex aligns diagnostic and financial stewardship for labs by only providing the test results needed at the appropriate cost per result
Deliver PCR results fast (without retesting) and manage fluctuating volumes with fewer people
Simplify lab logistics by offering a customizable solution out of one test kit (forecasting, quality control, inventory management, etc.)
Beyond workflow automation, get even more value from your cobas 5800/6800/8800 systems with industry-exclusive assay automation
Support PCR diagnosis across the continuum of care with cobas® liat, cobas® ePlex®, and cobas 5800/6800/8800 systems

Empowering PCR testing with TAGS technology

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Experience the power of TAGS with cobas Respiratory flex - one test, 15 results, available in a single well on your existing cobas® x800 instrument. Watch and discover the future of efficient PCR diagnosis!

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You need a PCR diagnosis fast. Imagine running just one test and getting the most relevant results from your existing Roche cobas instrument. What if that one test could generate routine and less common targets from a single well? And what if that one test could provide additional results, beyond what was originally requested, triggered by the initial findings? The results wouldn't be generated, then masked. The targets would only be analyzed once ordered, which would allow you to deliver just the results needed. Imagine if all this could be done in the same single run. This is our future.

TAGS is designed to work within the existing technology of the cobas 5800/6800/8800 systems, to generate up to 15 differentiated results using your current Roche instrument. That will be the true power you get with TAGS.

cobas Respiratory flex will be the first of future test kits to use TAGS. One test, one run. Only the relevant respiratory targets needed, with digital reflex using your current Roche instrument. From Point of Care to comprehensive syndromic testing to routine PCR testing with flexible multiplex and digital reflex, only Roche has all the pieces to strategically increase future efficiency across the continuum of care.

cobas Respiratory flex test clinical performance*

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Target virus	PPA	NPA
Influenza A	100.0%	99.1%
Influenza B	100.0%	99.8%
RSV	96.0%	99.8%
SARS-CoV-2	98.4%	98.2%
Adenovirus	100.0%	98.4%
Human Metapneumovirus	96.3%	99.8%
Enterovirus and Rhinovirus	83.9%	98.4%
Common Human Coronaviruses (229E, HKU1, NL63, OC43)	96.4%	97.3%
Parainfluenza virus 1	100.0%	99.3%
Parainfluenza virus 2	100.0%	99.6%
Parainfluenza virus 3	95.8%	99.9%
Parainfluenza virus 4	97.4%	99.5%

cobas Respiratory flex test specifications

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Product specification	Value
Targets	Influenza A virus, influenza B virus, respiratory syncytial virus (RSV), SARS-CoV-2, adenovirus (species B, C, and E), human metapneumovirus, human rhinovirus/enterovirus, common human coronaviruses (229E, HKU1, NL63, OC43), parainfluenza viruses 1, 2, 3, and 4
Sample type	Nasopharyngeal swab samples collected in Copan Universal Transport Medium System (UTM-RT®) or BD™ Universal Viral Transport System (UVT) or equivalent
Minimum amount of sample	0.4 mL
Technology	First assay using Roche’s proprietary TAGS technology (Temperature Activated Generation of Signal) to enable higher multiplex within existing hardware and system software.
Size	192 tests
Open kit stability	90 days with 40 re-uses

Overview

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