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cobas® 8800 System

Welcome to the future of molecular testing

IVD For in vitro diagnostic use.
cobas® 8800 System
Unrivaled diagnostic performance, today and into the future

The cobas® 8800 System can help you meet the growing needs of your lab with highly efficient workflows, from sample processing to result interpretation. Deliver trusted, reproducible results while rapidly completing your daily testing requirements.

 

cobas 8800 system
cobas 6800

Generate trusted, reproducible results with proven performance

cobas 6800

Leverage absolute automation to drive increased effeciency

cobas 6800

Deliver unmatched flexibility to meet your molecular testing demands — today and tomorrow

FIRST AND ONLY high volume fully automated system with a moderate complexity classification

 

Proven performance

Rapidly complete daily testing requirements

  • Since the launch of the cobas 8800 in 2015, hundreds of systems have been installed delivering consolidated testing and increased efficiency for laboratories 
  • Delivers rapid time to result, completing up to 96 tests in about 3 hours
  • Provides trusted, reproducible results with assay performance held to the rigorous standards you expect from Roche
  • Delivers unparalleled throughput for routine molecular testing
cobas 8800 throughput
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Absolute automation

Fully automated workflow from sample transfer to results

cobas 8800

cobas 8800 system

4 hours work-away time*

Transform "walk-away" time into "work-away" time. Minimal and intuitive interactions reduce the potential for human error and free-up technicians for other tasks. 

  • Pre-Calibrated, ready-to-use reagents do not require thawing, mixing, pouring or calibrations. Load and go. 
  • Automated onboard storage and refrigeration system enable ready access and maintain inventory of consumables and reagents 

*May vary based on workflow demands.

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Molecular testing - at any volume - in three easy steps 

cobas 6800

1. Load reagents & consumables

cobas 6800

2. Load samples

cobas 6800

3. Empty waste & review results

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Unmatched flexibility

Flexible sample loading, processing, and testing

1

technician

1

system

30

minutes set-up

1,056

results with 4 hour
work-away time

1

system

run IVDs and LDTs on a single system with the cobas omni Utility Channel

1

single point of entry

lets the system do the work while staff performs critical tasks

3

tests from one tube

and 3 tests simultaneously on up to 4 thermocyclers for ultimate testing flebibility

12

assays in on board

run the tests you want, when you want

22

assays in 2023

an expanded menu supports true test consolidation

350

sample capacity

supports continuous loading and the highest work-away time

5,760

on-board test capacity

with 90-days stability

0

no reagent preparation, no manual pipetting, no sorting or batching or setting up subsequent runs - 

the cobas 8800 System does it all for you

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Contamination prevention

Built-in features to ensure the highest quality and integrity of patient results with no daily maintenance

  • Airlock doors with HEPA filtration
  • Pipette tips with filter technology
  • Dedicated pipette tips for each sample transfer and for transfer of extracted nucleic acid
  • Automatic heat-sealing of cobas omni Amplification Plate
  • Amperase included in every assay
  • Stainless steel 8-fold needle popetting transfers assay-specific reagents, controls and other bulk reagents required for sample preparaton and amplification; washed after each use
  • No use of bleach on the systems
alt

With a broad on-demand assay menu, the cobas 8800 System allows you to run the tests you want, when you want. 

Further flexibility is possible with the cobas omni Utility Channel, a dedicated open channel for both IDV assays and high-volume labortory developed tests (LDTs). The cobas omni Utliity Channel creates an opportunity to broaden youjr menu and automated more testing on the cobas 8800 System.
Molecular Assays

Blood-borne disease

Respiratory

Sexual health

Transplant

  • CMV
  • EBV
  • BKV
  • ADV Quant (RUO) † ‡
  • HSV/VZV (RUO) † ‡

cobas omni Utility Channel for third-party tests and LDTs

‡  For Research Use Only. Not for use in diagnostic procedures.

†  This product is in development. This product is not available for use in the U.S.

§ This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

SARS-CoV-2:

This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,

SARS-CoV-2 & Influenza A/B:

This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

cobas® 6800/8800 Systems Specifications Comparison

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cobas® 6800/8800 Systems Specifications Comparison

Performance

Performance

  cobas® 6800 System cobas® 8800 System
Time to first results (up to 96 tests) < 3.5 hours
Subsequent batches (96 tests) Every 90 minutes thereafter Every 30 minutes thereafter
Maximum throughput * 
(8 hours)<		 384 1056
Walk-away time * 8 hours 4 hours
Maximum number of tests per run 96 tests, including controls
Results released Plates of up to 96 tests, with up to 3 assays per plate
User interactions 1. Load/unload samples, load reagents and consumables as needed 
2. Remove waste (solid and liquid) 
3. Review and release results
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Onboard inventory

Onboard inventory

  cobas® 6800 System cobas® 8800 System
Samples 350
Assay reagent cassettes Up to 12
Control cassettes Up to 8
cobas omni MGP reagent 2 4
cobas omni specimen diluent reagent 
(1 L bottle)		 2 4
cobas omni lysis reagent (1 L bottle) 2 4
cobas omni wash reagent (5 L bottle) 3 6
cobas omni processing plates 8 16
cobas omni amplification plates 8 16
cobas omni pipette tips 8 16
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Compatible tubes (both Systems)

Compatible tubes (both Systems)

Tube size Acceptable measurement (mm)
Height 65–103
Outside diameter (includes barcode label) 12–16.2
Tube dimensions acceptable for use on the cobas® 6800/8800 System:
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Barcode types supported — both Systems (1–23 characters)

Barcode types supported — both Systems (1–23 characters)

  • Codabar
  • Code 128
  • Code 39
  • Code Interleaved 2 of 5
  • Code 93
  • Code EAN-8
  • Code EAN-13 (including JAN code)
The cobas® 6800/8800 System only supports ASCII Codes 32–126 in the barcode.
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Power supply

Power supply

  cobas® 6800 System cobas® 8800 System
Line voltage 200–240 VAC +/- 10%
Line frequency 50/60 Hz +/- 5%
Maximum power 3500 VA 8200 VA
Insulation coordination Installation Category II 
(IEC 61010-1)
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Dimensions and weight

Dimensions and weight

  cobas® 6800 System cobas® 8800 System
Fixed Moveable  
Instrument dimension 292 x 216 x 129 cm 
(W x H x D)		 292 x 222 x 129 cm 
(W x H x D)		 429 x 216 x 129 cm 
(W x H x D)
Instrument weight 
— Excluding instrument gateway server 
— Including instrument gateway server		   
1573 kg 
1624 kg		   
1701 kg 
1752 kg		   
2354 kg 
2405 kg
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Instrument gateway (both Systems)

Instrument gateway (both Systems)

  • Functions as a central server when interconnecting and operating multiple Systems
  • System interconnectivity: Up to 5 analytic systems and 4 poolers managed by a single instrument gateway
  • LIS connectivity: Uni- and bi-directional communication using HL7 standard protocol
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Contamination prevention (both Systems)

Contamination prevention (both Systems)

  • Airlock doors with HEPA filtration
  • Pipette tips with filter technology
  • Dedicated pipette tips for each sample transfer and for transfer of extracted nucleic acid
  • Stainless steel 8-fold needle pipetting transfers assay-specific reagents, controls and other bulk reagents required for sample preparation and amplification; washed after each use
  • Automatic heat-sealing of cobas omni Amplification Plate
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Pre-analytic solutions

Pre-analytic solutions

  • The cobas® 6800/8800 Systems will accept primary and secondary uncapped tubes in standard 5-position sample racks and are designed to be compatible with laboratory automation and conveying systems

    *May vary based on workflow demands

Transforming testing and treatment together

Roche has been pioneering innovation in molecular testing for decades and remains committed to supporting laboratories in meeting both their own needs and the needs of the patients everywhere.

Speak with your Roche representative to learn more

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Overview

Ordering Information

Technical Documents

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Document repository
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cobas® 6800 System Embrace the future of molecular testing with proven PCR performance. Learn about the cobas® 6800 System’s broad menu of high-quality assays, including HIV, HPV, CT/NG, Hepatitis, CMV, WNV, respiratory infections, and more!
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Digital LightCycler® System Unleash the true power of digital PCR
Country Specific Labeling See country-specific product labeling for regulatory status.
cobas z 480 analyzer
cobas z 480 analyzer The cobas z 480 analyzer is a component of the modular cobas® 4800 System, and can also exist as a standalone instrument for automated amplification and detection of clinical and research assays. The cobas z 480 analyzer offers advanced real-time PCR technology for high-quality results.
SARS_Influenza_AB
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Influenza A/B Assay
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cobas TV/MG test
cobas® TV/MG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® TV/MG on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.). cobas® TV/MG also detects TV DNA in cervical specimens collected in PreservCyt solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection.A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.
cobas SARS-COV-2 test
cobas® SARS-COV-2 Qualitative assay for use on the cobas® 6800/8800 Systems. cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in healthcare provider-instructed self-collected anterior nasal (nasal) swab specimens (collectedon site), and healthcare provider-collected nasal, nasopharyngeal and oropharyngeal swab specimens collected from any individuals, including those suspected of COVID-19 by their healthcare provider,and those without symptoms or other reasons to suspect COVID-19. cobas® SARS-CoV-2 is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests.This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples from healthcare provider-instructed self-collected nasal swab specimens (collected on site), or healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens. Negative results from pooled samples should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually.  Specimens included in pools with a positive or presumptive positive result must be tested individually prior to reporting a result. Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing. Testing of pooled samples is limited to laboratories certified under CLIA, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.Results are for the detection of SARS-CoV-2 RNA. The 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; 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 viruses.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate 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® 6800/8800 Systems. cobas® SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization.
IVD For in vitro diagnostic use.
<b>cobas</b>&reg; MRSA/SA Test
cobas® MRSA/SA Test for use on the cobas® 4800 System The cobas® MRSA/SA Test on the cobas® 4800 System, is a qualitative in vitro diagnostic real-time PCR assay, for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) and S.aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.
IVD For in vitro diagnostic use.
<b>cobas</b>&reg; BKV
cobas® BKV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems For accurate monitoring of BK polyomavirus (BKV) in transplant patients.
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<b>cobas</b><sup>®</sup> SARS-CoV-2 Qualitative
cobas® SARS-CoV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems 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. 
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<b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
cobas® SARS-CoV-2 Duo Qualitative and quantitative assay for use on the cobas® 6800/8800 Systems cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems (cobas® SARS CoV 2 Duo) is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider. cobas® SARS-CoV-2 Duo is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests.Results are for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. At this time, correlation of viral load with a specific clinical diagnosis, prognosis or patient management decision has not been clinically established. Patient management should therefore be based on the qualitative result upon consideration of clinical observation, patient history and other diagnostic information. The numerical values for the viral load are for information only. Positive results do not rule out bacterial infection or co- infection with other viruses.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. cobas® SARS-CoV-2 Duo 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® 6800/8800 Systems. cobas® SARS-CoV-2 Duo is only for use under the Food and Drug Administration’s Emergency Use Authorization.
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cobas HPV
cobas® HPV Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® HPV for use on the cobas® 5800/6800/8800 Systems (cobas® HPV) is a qualitative in vitro test for the detection of high-risk Human Papillomavirus. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in the specimens listed below. Clinician-collected cervical specimens should be obtained using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution.  Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained. cobas® HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors. CONTRAINDICATIONS: None
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Product Image for cobas® 4800 system
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<b>cobas</b><sup>®</sup> PIK3CA Mutation Test
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<b>cobas</b>&reg; CMV
cobas® CMV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment.The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.cobas® CMV is not intended for use as a screening test for blood or blood products.
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<b>cobas</b>&reg; Cdiff Test
cobas® Cdiff Test for use on the cobas® 4800 System The cobas® Cdiff Test on the cobas® 4800 System is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Test is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.
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cobas® HSV 1 and 2 Test for use on the cobas® 4800 System The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
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Country Specific Labeling See country-specific product labeling for regulatory status.
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cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
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<b>cobas</b>&reg; HBV
cobas® HBV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals.This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.The cobas® HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection. 
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IVD For in vitro diagnostic use.
<b>cobas</b>&reg; EBV
cobas® EBV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems PCR quantitation of Epstein-Barr (EBV) on the cobas® 5800/6800/8800 Systems
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<b>cobas</b><sup>®</sup> 4800 BRAF V600 Mutation Test
cobas® 4800 BRAF V600 Mutation Test The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling:TherapeuticTherapeutic IndicationTest ResultZELBORAF® (vemurafenib)BRAF V600EMutation DetectedCOTELLIC® (cobimetinib), in combination with ZELBORAF® (vemurafenib)BRAF V600E or V600K*Mutation Detected**Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation.
Country Specific Labeling See country-specific product labeling for regulatory status.
cobas SARS-CoV-2, Influenza A/B and RSV Nucleic Acid Test
cobas® liat SARS-CoV-2, Influenza A/B & RSV assay The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is 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. Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV 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 not detected by the test. The agent detected may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas® liat system and the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization.  
IVD For in vitro diagnostic use.
cobas eplex system
ePlex® System The only sample-to-answer solution on the market that streamlines the diagnostic workflow from your order entry to final report.
IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> HIV-1/HIV-2 Qualitative
cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® HIV-1/HIV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. The cobas® HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.
cobas Influenza A/B & RSV UC
cobas® Influenza A/B & RSV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
IVD For in vitro diagnostic use.
cobas SARS-COV-2 and Influenza A/B v2
cobas® SARS-CoV-2 & Influenza A/B v2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B v2) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C.RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B 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 viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.cobas® SARS-CoV-2 & Influenza A/B v2 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.
IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> KRAS Mutation Test
cobas® KRAS Mutation Test The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of somatic mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas® z 480 analyzer for automated amplification and detection. The cobas® KRAS Mutation Test detects the following KRAS mutations. Codon Mutation ID AA Change COSMIC ID 12 c.34G>T 12C 516 c.34G>A 12S 517 c.34G>C 12R 518 c.35G>T 12V 520 c.35G>A 12D 521 c.35G>C 12A 522 13 c.38G>A 13D 532 61   c.181C>A 61K 549 c.181C>G 61E 550 c.182A>C 61P 551 c.182A>G 61R 552 c.182A>T 61L 553 c.183A>C 61Hc 554 c.183A>T 61Ht 555
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