Search
User Profile
Change
Select your user profile

MagNA Pure 96 System

High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples.

IVD For in vitro diagnostic use.
MagNA Pure 96 System
Fully automated, high-throughout nucleic acid purification

Start here. Go anywhere.

The MagNA Pure 96 System ensures purity, reproducibility, and laboratory efficiency for a successful molecular diagnostic workflow. Process up to 96 samples in less than one hour and increase your laboratory productivity to meet your changing needs.

MagnaPure 96 Instrument from Roche

Quick time-to-result

  • Parallel process up to 10 sample types in same run with Universal Protocol
  • Process 1-96 samples with typical run duration of one hour
  • Up to 96 samples, simultaneously, in less than 30 minutes+
  • Less than 5 minutes hands-on time per run

+Fast Viral NA SV and Fast Viral NA ext lys SV protocols

Related information

Would you like to know more about the MagNA Pure 96 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

Effortless purification, confidence from automation

  • High-throughput instrument for automated nucleic acid purification
  • Proven performance delivering reproducible and consistent yields
  • Process up to 96 samples in less than 30 minutes
  • Support for a broad range of samples for use in a variety of downstream applications
  • Simplified workflow with ready-to-use prefilled reagent trays and streamlined kit offerings
  • Full traceability and connection to your laboratory information system
  • Minimized handling errors via detection, guidance and surveillance processes
  • Contamination prevention with built-in UV lamp and drop catcher plus CO-RE Tip technology

Prefilled, barcoded, and ready-to-use reagent kits

MagNA Pure 96 Kits are prefilled and ready-to-use reagent trays that can be easily loaded, ensuring ease of use and safety. Kits and consumables are barcoded and read by the MagNA Pure onboard scanner for inventory check, loading errors, and process documentation.

An intuitive user interface

MagNA Pure 96 Software includes an intuitive graphical user interface, providing all instructions to operate the system, such as sample loading to run start. The software detects loading errors and provides information to the user for the appropriate corrective action.

A new dimension in productivity

Experience high throughput automation combined with high performance while increasing your laboratory productivity to meet your changing needs. Magnify your lab’s efficiency with seamless data management and expand your capacity for diverse day to day throughput needs.

You might be interested in

...
    ...
    MagNA Pure 96 System

    Overview

    Ordering Information

    Technical Documents

    multilangimg
       
    Document repository

    MagNA Pure 96 Technical Specifications

    View Full Table
    close

    MagNA Pure 96 Technical Specifications

    Dimensions 137 cm W x 80 cm D x 100 cm 
    53.9" W x 31.5" D x 39.4" H
    Weight Approx. 235 kg/518 lbs (instrument)
    Pipetting Heads 96 Channel Processing Head with disposable tips 
    4 Channel multi-dispensing Reagent Head with steel needles
    Thermo Elements 1 Heating Block, 1 Cooling Block
    Safety Provisions Drop catcher, UV lamp for decontamination
    Power Supply 100 to 125 V (-15%, +10%) 
    200 to 240 V (-15%, +10%)
    Sample Number 1 to 96 reactions per run
    Sample Volumes 50 to 500 μl with 96 reactions per run 
    1000 μl with 48 reactions per run
    4000 uL with 48 recations per run (plasma)
    Run Time Approx. 30-90 minutes depending on protocol
    Setup Time Less than 5 minutes
    Control SW Software, including preprogrammed purification protocols
    protocol sheet
    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.
    cobas® 5800 System
    cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
    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.
    digital lightcycler product thumbnail
    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
    cobas® SARS-CoV-2 &
    Influenza A/B Assay
    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.
    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.
    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.
    <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 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
    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.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    <b>cobas</b><sup>®</sup> PIK3CA Mutation Test
    cobas® PIK3CA Mutation Test
    IVD For in vitro diagnostic use.
    cobas prime pre-analytical system
    cobas® prime Pre-analytical System The industry’s leading instruments converge to form a single solution that transforms your operation into a laboratory of the future. This fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline lab operations.
    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.
    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.
    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.
    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.
    LightCycler® PRO System
    LightCycler® PRO System LightCycler® PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results
    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.
    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>&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.
    <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
    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later