For in vitro diagnostic use. Others cobas SARS-CoV-2 Liat IVD cobas® SARS-CoV-2 RMD-Liat-SARS-003 Nucleic acid test for use on the cobas® liat system 09 408 592 190 9 408 592 190 09408592190 9408592190 09408592190 KIT COBAS LIAT SARS-COV-2 cobas SARS-CoV-2 00875197006742 Reagents, kits 1 pack 20 tests true The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2) is an automated, real- time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection (i.e., symptomatic). Additionally, this test is intended to be used with nasal and nasopharyngeal swab specimens collected from individuals without signs and symptoms suspected of COVID-19 (i.e., asymptomatic). The cobas® SARS-CoV-2 performed on the cobas® Liat® System is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out co-infection with other microorganisms. A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal swab collected from an asymptomatic patient should be followed up by testing at least twice over three days with at least 48 hours between tests. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Point-of-Care settings. en 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 SARS-CoV-2 in self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal and nasal swabs from either individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider or from individuals without symptoms or other reasons to suspect COVID-19. cobas® SARS-CoV-2 is intended for use in the detection of SARS-CoV-2 in clinical specimens. SARS-CoV-2 viral RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Negative results do not preclude infection from SARS-CoV-2 and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. cobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat® System in Near Patient Testing, Point of Care (POC) or in a clinical laboratory setting. en 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 SARS-CoV-2 in self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal and nasal swabs from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. cobas® SARS-CoV-2 is intended for use in the detection of SARS-CoV-2 in clinical specimens. SARS-CoV-2 viral RNA is generally detectable in upper respiratory specimens during theacute phase of infection. Positive results are indicative of active infection but do not rule out co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Negative results do not preclude infection from SARS-CoV-2 and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. cobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat® System in Near Patient Testing, Point of Care (POC) or in a clinical laboratory setting. en The cobas® SARS-CoV-2 assay is performed on the cobas® Liat® Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time RT-PCR assays. The assay targets both the ORF1 a/b non-structural region and structural nucleocapsid protein (N) gene that are unique to SARS-CoV-2. An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through steps of sample purification, nucleic acid amplification, and to monitor the presence of inhibitors in the RT-PCR processes. en

cobas^® SARS-CoV-2

Nucleic acid test for use on the cobas^® liat system

IVD

Help prevent the silent spread of SARS-CoV-2

SARS-CoV-2 may be difficult for clinicians to identify on symptoms alone. Many patients may be asymptomatic and if left undiagnosed, it may result in health complications or community spread.

With more than 6.9 million deaths and over 771 million cases¹ of COVID-19 reported so far worldwide, effective tools are needed to deliver rapid results to identify symptomatic and asymptomatic individuals infected with SARS-CoV-2.

cobas® SARS-CoV-2 is the first real-time polymerase chain reaction (PCR) test that provides targeted identification within 20 minutes for both asymptomatic and symptomatic persons, enabling informed decisions at the point of care.

cobas® SARS-CoV-2:

Screen asymptomatic individuals in 20 minutes to help prevent the silent spread of SARS-CoV-2
Mobilize fast testing at your priority points of care for greater access for patients
Broad strain coverage of SARS-CoV-2 variants for further reassurance with care decisions

The cobas® SARS-CoV-2 assay runs on the cobas® liat system. Choosing speed and accuracy, anywhere and anytime is the Roche Total Solution for all that you value. The total point-of-care solution that is simply quick, gives you the confidence of PCR accuracy, and puts you in control, now with conveniently remote results, automatic reporting and one-click updates.

cobas^® SARS-CoV-2 Performance^*

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	Positive Agreement^**	Negative Agreement^**
Symptomatic individuals LOD: 1.2 x 10-2 TCID ₅₀/mL	96.1 % (95% CI: 89.0%-98.6%)	96.8 % (95% CI: 92.6%-98.6%)
Asymptomatic individuals LOD: 1.2 x 10-2 TCID ₅₀/mL	100 % (95% CI: 84.5%-100%)	98.9 % (95% CI: 96.2%-99.7%)

* - cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System - IFU - EUA-IVD, v3.0, 06-04-2023; cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System - CE - IVD - English v2.0, 11-01-2023, Pleasanton, CA; Roche Molecular Systems. **Compared to an EUA molecular assay FDA-authorized for COVID-19 screening and diagnostic testing; EUA data. CI=confidence intervals. LOD=limit of detection. TCID=tissue culture infective dose.

Learn more about the expanding menu of assays

IVD

cobas^® SARS-CoV-2 & Influenza A/B Assay

Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® liat system.

IVD

cobas^® Influenza A/B & RSV Assay

Diagnose and differentiate influenza A/B & RSV for effective clinical management and infection control with the POC multiplex PCR test for use on the cobas® liat system.

IVD

cobas^® Strep A Assay

With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® liat system aids clinicians to make immediate, informed treatment decisions.

IVD

cobas^® Cdiff

Provide accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff with the POC PCR test for use on the cobas® liat system.

...

cobas^® liat system

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

Learn more

Intended Use

CE-IVD

The cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - IFU - EUA-IVD, v3.0, 06-04-2023; cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - CE - IVD - English v2.0, 11-01-2023. Pleasanton, CA; Roche Molecular Systems is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of SARS-CoV-2 in self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal and nasal swabs from either individual suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider or from individuals without symptoms or other reasons to suspect COVID-19.

cobas^® SARS-CoV-2 is intended for use in the detection of SARS-CoV-2 in clinical specimens. SARS-CoV-2 viral RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out co‑infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Negative results do not preclude infection from SARS-CoV-2 and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

cobas^® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® liat system at the point of care (POC) or in a clinical laboratory setting.

US FDA EUA

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.

Results are for the identification of SARS-CoV-2 nucleic acids. SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other viruses. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

cobas^® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® liat system.

In the United States (US), testing with cobas^® SARS-CoV-2 is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests. cobas^® SARS-CoV-2 is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Laboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.

In the U.S., cobas^® SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization."

Registration status

CE-IVD, FDA Emergency Use Authorization (EUA)

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.

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cobas^® SARS-CoV-2