Search

cobas® prime pre-analytical system

Accelerating speed and efficiency in the molecular lab

IVD For in vitro diagnostic use.
cobas prime pre-analytical system
Streamlining and simplifying your lab operation

In today’s fast-paced molecular laboratories, efficiency and flexibility are critical to avoid a bottleneck of samples requiring pre-analytics processing. Imagine a solution that automatically prepares the variety and volume of samples you receive. That’s the cobas® prime Pre-analytical System.

As the first and only fully automated system that consolidates, integrates and standardizes the pre-analytical process, it streamlines and simplifies your lab operation so technicians can focus on higher-level challenges and opportunities.

Introducing cobas prime Pre-analytical System
Would you like to know more about the cobas® prime Pre-analytical System?

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

Form Successfully Submitted!
Thank you for your submission!
text
close

Automation

Manual pre-analytical steps are performed for you

The cobas® prime Pre-analytical System offers complete automation and continuous random loading to achieve an unprecedented level of efficiency in the molecular lab.

  • An automated workflow helps protect the lab from cross contamination, processing error and missteps that can occur during scanning, aliquoting, sample preparation and reagent preparation
  • The system continuously loads — without presorting —multiple molecular sample types for multiple tests into a universal tray and performs pre-analytical processing before transferring the samples to the analyzer for testing
cose-up of barcode, automation image

Consolidation

One universal sample input tray, with no sorting or batching

Multiple sample types and tests can be consolidated to streamline the pre-analytical process and reduce the amount of training required.

  • A single universal tray holds multiple sample types and is placed into a single system, eliminating the need for a variety of instruments to process a variety of sample types
  • The universal tray can be filled with samples in sample reception, then loaded directly into the cobas® prime Pre-analytical System without any additional manual handling
  • An optional Process Pluss Module provides broader functionality including reagent addition and re-capping tubes
close-up of lab technician’s face, consolidation image

Integration

Solve your testing challenges with a single solution

Utilize industry leading instruments to form a single solution that transforms your operation into a laboratory of the future.

Close up of sample track

Standardization

Unrivaled workflow standardization

  • Improve ease of use and reduce staff training using a single instrument that can handle multiple sample types
  • Reliably deliver predictable and efficient turnaround time and throughput
Lab technician touching monitor, integration image
“Work-away” time
 “Work-away” time

 

Elevate efficiency with full automation.

High throughput
High throughput

 

Process an unmatched number of samples from an 8-hour shift.*

Loading capacity
Loading capacity

 

High capacity for increased efficiency and work-away time.

Standardized workflow
Standardized workflow

 

Streamline processes to get more done with less.

* Tubes decapping only workflow. Data on file with Roche.

 

 

 

 

Overview

Ordering Information

Technical Documents

multilangimg
   
Document repository

Technical Specifications

Performance

View Full Table
close

Performance

   
Available throughput (8 hrs. | 24 hrs.)* Up to 1600 | Up to 4800
Specific throughput

Liquid Based Cytology - Throughput 96/h

  • ThinPrep® PreservCyt Solution
  • User Defined Workflow

Primary Tubes - Throughput 200/h

  • Decapping
  • Recapping for archiving
Work-away time* Up to 6.5 hours (continuous loading supported)
User interactions
  • Load/unload samples
  • Load consumables
  • Load reagents (optional Process Plus Module only)
  • Remove waste (solid and liquid)
  • Address samples with processing errors directly at the workbench or via error tray
  • Routine weekly maintenance (cleaning)
  • Change barcode label materials
cobas® prime Workflows

Perform fully automated user workflows. Configurable parameters:

  • Tube type ID
  • Sample Integrity Checks
  • Vortexing
  • Decapping
  • Barcode labeling
  • Aliquoting
  • Recapping
  • Recursive recapping workflow
  • Heat treatment** (configured to heat samples to a predefined temperature (35-120°C) and keep it constant for the required time)
  • Cooling**
  • Reagent addition**
Sample type compatibility
  • LBC (Liquid Based Cytology)
  • cobas® PCR Media Urine
  • cobas® PCR Media Uni and Dual Swab
  • Serum/plasma (decapping only)
* May vary based on workflow demands and tube type.
** Note that functionality for customers to create their own user-defined workflows, for a vial within specifications, will be available under the responsibility of the customer.

Barcode types supported

View Full Table
close

Barcode types supported

1-23 characters

1-23 characters

   
1D barcodes*
  • Codabar
  • Code 128
  • Code 39
  • Code interleaved 2 of 5 (with checksum)
  • Code 93
  • Code EAN-8
  • Code EAN-13 (including JAN code)
2D barcodes*
  • QR Code
  • Data matrix
  • PDF417
  • AZTEC
* The cobas® prime Pre-analytical System supports ASCII codes 32-126 in the barcode

Connectivity

View Full Table
close

Connectivity

   
Host connectivity (LIS, Middleware, etc.)

HL7 through TCP/IP, bidirectional communication

  • Query for sample orders (LAB-22)
  • Sample order status change (LAB-26: Sample status, Sample integrity status, primary and secondary sample location)

Note: Requires unique sample ID and test code
Automated sample transport Can be connected to an approved track system (example: cobas® connection module)
Roche remote support 

Remote service connection

  • Download of configuration updates
  • Upload anonymized statistics for preventive maintenance
  • Screen sharing for remote support

Compatible sample containers

View Full Table
close

Compatible sample containers

Size

Acceptable measurement (mm)
Tube height 65 -100
Tube outside diameter (includes barcode label) 12.5 -16 (+/- 0.8mm)
LBC height 52.4 - 75.4 (+/- 1.14 mm)
LBC diameter 12.5 -16 (+/- 0.8mm)

Onboard inventory

View Full Table
close

Onboard inventory

Tube size Acceptable measurement (mm)
Samples (in universal trays) Liquid-based cytology container up to 380 or Primary/Secondary tubes up to 1240
Pipette tips (in trays) 384 tips per tray
Secondary tubes (in trays) 170 tubes per tray
Total tray storage (sample + consumable) Up to 22 trays
Total tray storage (sample + consumable) Up to 22 trays
Universal stoppers (flexible caps) Approx. 500 pieces
5-position-racks Up to 105 5-position racks

Reagent bottles*

  • cobas® sample preparation buffer (2 x 1 L bottle)
  • cobas® PCR media (2 x 1 L bottle)
  • Sample Preparation Extraction Reagent (SPER) (2 x 1 L bottle)
  • Customer defined reagent bottles (2 x 1 L bottle)
 6 x 1 L bottles (3 pairs)
* Reagents are only used in User Defined workflows

Power supply

View Full Table
close

Power supply

  Without Process Plus Module With Process Plus Module
Line voltage

1 phase 200-240 VAC +/- 10%
1 phase 100-125 VAC +/- 10% 16 A or higher socket

 1 phase 200-240 VAC +/- 10% 16 A or higher socket
Line frequency 50/60Hz +/- 5% 50/60Hz +/- 5%
Maximum power 1600 VA 3200 VA
Insulation coordination Installation category II (IEC 61010-1)  

Environmental requirements (operating)

View Full Table
close

Environmental requirements (operating)

   
Ambient room temperature 15º C or 59º F to 30º C or 86º F
Relative humidity 
 15% to 85% (no condensation)
Altitude 
 up to 2000m (6562 ft)
Noise emission 
 below 65 dB (A) peak noise level 55 dB during operation
Pollution Range 
 Degree 2
Heat Dissipation 
 <11895 BTU/h

Dimensions and weight

View Full Table
close

Dimensions and weight

  cobas® prime Pre-analytical System without Plus Module cobas® prime Pre-analytical System with Plus Module
Instrument dimensions 87 x 69 x 86 in with status light (W x D x H) Depth including workbench 71.25” 111x 69 x 86 in with status light (W x H x D) Depth including workbench 71.25”
Instrument weight 
 2541 lbs. 3366 lbs.
GLU For general laboratory use.
VENTANA Connect middleware
VENTANA Connect middleware VENTANA Connect middleware is software that links your existing Laboratory Information System (LIS) with the entire portfolio of Roche Tissue Diagnostics instruments and systems.
IVD For in vitro diagnostic use.
cobas® connection modules (CCM)
cobas® connection modules (CCM) cobas® connection modules allow the connection of the standalone automation systems, cobas p 512 and cobas p 612, to analytics and post-analytics through a fast track.
Product image for cobas® infinity laboratory solution
cobas® infinity laboratory solution cobas® infinity central lab was designed to allow you to identify, address and solve your lab’s biggest challenges, using a single, easy-to-use solution. Take integration to the next power with cobas® infinity IT solutions. It was designed from the drawing board for people to work to their full potential. With cobas® infinity IT solutions powering your lab, performance that was once not possible, is now a reality.
IVD For in vitro diagnostic use.
cobas p 501 / p 701 post-analytical units
cobas p 501 / cobas p 701 post-analytical units The cobas p 501 / cobas p 701 post-analytical units are refrigerated archiving systems that simplify sample retrieval and management of add-on testing.
IVD For in vitro diagnostic use.
Product image for cobas® 8100 automated workflow series
cobas® 8100 automated workflow series cobas 8100 intelligent tube transport provides a short predictable time to results, including prioritization for emergency samples. With flexible workflows, early error detection and fully automated add-on handling, cobas 8100 allows for personalized solutions to suit individual laboratory needs, guaranteeing that quality comes first.
Country Specific Labeling See country-specific product labeling for regulatory status.
Product image for LightCycler® 2.0 System
LightCycler® 2.0 System Monitor amplification of 32 PCR products simultaneously and obtain fast, highly reproducible results with the LightCycler® 2.0 System.
IVD For in vitro diagnostic use.
Product image for MagNA Pure 24 System
MagNA Pure 24 System A fully-automated clinical nucleic acid extraction system that brings you walkaway automation for up to 24 samples. Designed around the real needs of modern laboratories. Prepare up to 24 samples in just over an hour, or run the fast protocol for up to 8 samples in 30 minutes or less. Flexibility starts here.
IVD For in vitro diagnostic use.
MagNA Pure 96 System
MagNA Pure 96 System High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples. Take your lab to new levels of efficiency. Purify DNA and RNA from a wide range of starting materials using magnetic glass particle technology on the MagNA Pure 96 System.
IVD For in vitro diagnostic use.
Country Specific Labeling See country-specific product labeling for regulatory status.
cobas x 480 instrument
cobas® x 480 instrument The cobas x 480 provides sample preparation, amplification and detection of specific targets from human samples.
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.
IVD For in vitro diagnostic use.
cobas® 6800 System
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!
IVD For in vitro diagnostic use.
cobas® 8800 System
cobas® 8800 System Run up to 1,056 tests in an 8-hour shift and experience unparalleled automation—only 3 user interactions per run for up to 4 hours of walk-away time.
IVD For in vitro diagnostic use.
<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.
IVD For in vitro diagnostic use.
<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.
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.
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; 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
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.
RUO For Research Use Only. Not for use in diagnostic procedures.
<b>cobas</b><sup>®</sup> PIK3CA Mutation Test
cobas® PIK3CA Mutation Test
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.
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 Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.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 women 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.
IVD For in vitro diagnostic use.
cobas 4800 system
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.
IVD For in vitro diagnostic use.
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.
IVD For in vitro diagnostic use.
cobas CT/NG
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.
IVD For in vitro diagnostic use.
<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. 
IVD For in vitro diagnostic use.
GenMark 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.
Product Image for cobas® 4800 system
cobas® 4800 System Discover real-time PCR amplification and detection featuring fully automated sample preparation, high quality nucleic acid extraction and robust engineering.
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.
IVD For in vitro diagnostic use.
<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. 
IVD For in vitro diagnostic use.
cobas® Liat System
cobas® liat system Bring accurate and reliable PCR results to the POC, enabling answers patients and clinicians need in 20 minutes or less to support triage and patient management.
IVD For in vitro diagnostic use.
<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.
IVD For in vitro diagnostic use.
cobas® 5800 System
cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
SARS_Influenza_AB
cobas® SARS-CoV-2 &
Influenza A/B Assay
error errorMessage
Sorry, we couldn't find the content you are looking for
Please try again later