cobas® SARS-CoV-2 Qualitative (original) (raw)

For in vitro diagnostic use. Others cobas SARS-CoV-2 Qualitative Test 5800-6800-8800 IVD cobas® SARS-CoV-2 Qualitative PID00000056 Nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 448 870 190 9 448 870 190 09448870190 9448870190 09448870190 KIT COBAS 58/68/88 SARS-COV-2 480T IVD cobas SARS-CoV-2 Qualitative 00875197006933 Reagents, kits 1 kit 480 tests true 09 446 109 190 9 446 109 190 09446109190 9446109190 09446109190 KIT COBAS 58/68/8800 SARS-COV-2 192T IVD cobas SARS-CoV-2 Qualitative 00875197006841 Reagents, kits 1 kit 192 tests true cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. cobas® SARS-CoV-2 Qualitative is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems. en cobas® SARS-CoV-2 Qualitative 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 or cobas® 6800/8800 Systems software(s), which assigns test 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 for ORF1 a/b non-structural region that is unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene were chosen for pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.The cobas® SARS-CoV-2 Qualitative master mix contains detection probes which are specific for the coronavirus type SARS-CoV-2, members of the Sarbecovirus subgenus, and the RNA Internal Control nucleic acid. The coronavirus and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. 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. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified coronavirus target and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine 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

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Nucleic acid test for use on the cobas® 5800/6800/8800 systems

IVD For in vitro diagnostic use.

Robust, high-volume SARS-CoV-2 testing providing reliable results important for clinical decision-making

The cobas® SARS-CoV-2 Qualitative Test provides reliable and high-quality results for the improved management of COVID-19, in individuals suspected of COVID-19 by their healthcare provider. Healthcare professionals can use this test to assess if patients are at risk of developing the disease by this pathogen, which can contribute to severe respiratory distress, complications, and potential death.

Features and benefits of the cobas® SARS-CoV-2 Qualitative Test

The cobas®SARS-CoV-2 Qualitative Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-Sarbecovirus detection for the Sarbecovirus subgenus family that includes SARS-CoV-2. The assay has a full-process negative control, positive control and internal control. Two kit sizes accommodating either 192 or 480 test reactions are available.

Claims include:

• Use of nasal and nasopharyngeal swab sample types
• Use of collection and transport media
  • cobas PCR Media Dual Swab Kit
  • cobas PCR Media Uni Swab Kit
  • cobas PCR Media Kit
  • Copan Universal Transport Media (UTM-RT)
  • BD™ Universal Viral Transport (UVT)
  • 0.9% Physiological Saline

Please refer to the IFU for acceptable sample type and collection device combinations

Would you like to know more about the cobas® SARS-CoV-2 Qualitative Test?

Please submit your information in the following form to be contacted by a Roche representative with more details.

Accuracy

Robust performance achieved by targeting conserved regions within the ORF 1a/b and E genes

Simplicity & efficiency

Ready to use reagents and controls minimizing variability while simplifying the workflow and reducing risk of error

Specificity

Full-process controls with negative, positive and internal controls

Hands-on Time

With only 3 manual interactions, up to 8 hours of walk-away time

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2)

Since the start of COVID-19 pandemic, Roche is focused on bringing effective diagnostic solutions to healthcare communities worldwide in the fight against the disease.

As communities across the globe still need effective solutions for COVID-19, Roche continues to invest in diagnostics to ensure there are testing options available to healthcare communities and patients worldwide.

* cobas® SARS-CoV-2 Qualitative assay for use on the cobas 5800/6800/8800 Systems (192T & 480T) - Instructions for use

a LoD determined with WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)

b one TCID50/mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA1/2020, infectious culture, Cat No NR-52281, Lot 70033175)

Intended Use

Intended Use

cobas® SARS CoV-2 Qualitative test for the 5800/6800/8800 Systems (FDA 510(k) clearance)

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. cobas® SARS-CoV-2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.

Registration Status

FDA 510(k) clearance

Overview

Detailed Specifications

Ordering Information

Technical Documents

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