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cobas® Plasma Separation Card

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> Plasma Separation Card

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Detailed Specifications

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Compatible Instruments

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    Technical Documents

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    Country Specific Labeling See country-specific product labeling for regulatory status.
    Product image for LightCycler® 96 System
    LightCycler® 96 Instrument Obtain fast, highly sensitive, and reproducible results for qualitative and quantitative detection of nucleic acids and SNP analysis with the LightCycler® 96.
    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
    Country Specific Labeling See country-specific product labeling for regulatory status.
    Product image for LightCycler® 2.0 System
    LightCycler® 2.0 Instrument 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 Instrument 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.
    Product image for MagNA Pure 96 System
    MagNA Pure 96 Instrument 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.
    cobas® SARS-CoV-2 test kit
    cobas® SARS-CoV-2 Test
    IVD For in vitro diagnostic use.
    digital lightcycler product thumbnail
    Digital LightCycler® System Unleash the true power of digital PCR
    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.
    cobas s 201 system
    cobas® s 201 system Experience the combination of real-time PCR technology and modular automation in the first multi-dye, nucleic acid amplification technology (NAT) screening system for blood and plasma.
    IVD For in vitro diagnostic use.
    cobas p 480 instrument
    cobas p 480 Instrument Improve workflow, reduce the risk of contamination, and make the most of your technician’s time. For support of cobas® 4800/6800/8800 Systems.
    IVD For in vitro diagnostic use.
    cobas® Liat® Systeem
    cobas® liat system Breng nauwkeurige en betrouwbare PCR-resultaten naar Point of Care, zodat patiënten en clinici binnen 20 minuten of minder de antwoorden krijgen die ze nodig hebben om triage en patiëntbeheer te ondersteunen
    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.
    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><sup>®</sup> CT/NG
    cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Factor II and Factor V Test
    cobas® Factor II and Factor V Test
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MPX
    cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MPX
    cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 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
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> ADV/hMPV/EV-RV UC
    cobas® ADV/hMPV/EV-RV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (PCR) assay for the timely in vitro qualitative detection and discrimination of human Adenovirus (ADV), Metapneumovirus (hMPV) and Enterovirus/Rhinovirus (EV-RV).This test is intended for the use as an aid in the diagnosis and differentiation of ADV, hMPV and EV-RV in nasopharyngeal swab specimens from patients with signs and symptoms of a respiratory infection.The results from cobas® ADV/hMPV/EV-RV UC must be interpreted within the context of all relevant clinical, epidemiological, and laboratory data. Negative results do not preclude viral infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, 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. The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is intended for professional use in a clinical laboratory setting.
    <b>cobas</b><sup>®</sup> Paraflu 1-4 UC
    cobas® Paraflu 1-4 UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Babesia
    cobas® Babesia Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MAI
    cobas® MAI for use on the cobas® 5800/6800/8800 Systems cobas® MAI for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in human respiratory specimens including raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples. This test is intended for use in conjunction with mycobacterial culture as an aid in the diagnosis of pulmonary M. avium and M. intracellulare complex (MAC) infections.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MTB
    cobas® MTB for use on the cobas® 5800/6800/8800 Systems cobas® MTB for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycobacterium tuberculosis complex (MTBC) DNA in either acid-fast bacillus (AFB) smear-positive or smear-negative, human respiratory specimens; including raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples.This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended for the aid of pulmonary tuberculosis diagnosis, and in conjunction with culture and other laboratory findings, as well as clinical signs and symptoms.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HCV
    cobas® HCV Quantitative nucleic acid test for use on the cobas® 4800 System
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> TaqScreen MPX Test, version 2.0
    cobas® TaqScreen MPX Test, version 2.0
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HBV
    cobas® HBV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    <b>cobas</b><sup>®</sup> HBV
    cobas® HBV Quantitative nucleic acid test for use on the cobas® 4800 System
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> DPX
    cobas® DPX Duplex HAV & parvovirus B19 nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma.This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MTB-RIF/INH
    cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of rifampicin-resistance associated mutations of the rpoB gene, and isoniazid-resistance associated mutations in the katG and inhA genes, of Mycobacterium tuberculosis, from human respiratory specimens. The test is intended for use on raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/ NaOH treated) sputum and bronchial alveolar lavage (BAL) samples, that tested positive for Mycobacterium tuberculosis complex (MTBC) by cobas® MTB. This test is intended for use in conjunction with culture and drug susceptibility testing, and as a reflex test together with cobas® MTB, as an aid in the diagnosis of infection with a multidrug resistant M. tuberculosis (MDR-TB).
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CHIKV/DENV
    cobas® CHIKV/DENV Nucleic acid test for use on the cobas® 6800/8800 Systems cobas® CHIKV/DENV for use on the cobas® 6800/8800 Systems is a qualitative in vitro test for the direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV) serotypes 1-4 RNA in human plasma.The test is intended for use to screen donor samples for CHIKV RNA or DENV RNA alone or to simultaneously screen for both CHIKV and DENV RNA in plasma from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use of samples of cord blood.This test is not intended for use as an aid in diagnosis for CHIKV or DENV.
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> Respiratory flex
    cobas® Respiratory flex Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> DNA Sample Preparation Kit
    cobas® DNA Sample Preparation Kit The cobas® DNA Sample Preparation Kit is used for manual sample preparation to isolate genomic DNA from formalin-fixed paraffin-embedded tumor tissue (FFPET) samples.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> 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> HPV
    cobas® HPV Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HEV
    cobas® HEV Nucleic acid test for use on the cobas® 5800/6800/8800 Systems The cobas® HEV test for use on cobas® 5800/6800/8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (HEV) RNA (genotypes 1-4) in human plasma.This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (red cells, platelets, and plasma), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for HEV.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HIV-1
    cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> cfDNA Sample Preparation Kit
    cobas® cfDNA Sample Preparation Kit The cobas® cfDNA Sample Preparation Kit is used for manual sample preparation to isolate circulating cell-free DNA (cfDNA) from plasma samples.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> TV/MG
    cobas® TV/MG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    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
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MRSA/SA Test
    cobas® MRSA/SA Test for use on the cobas® 4800 System
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Influenza A/B &amp; 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.
    <b>cobas</b><sup>®</sup> BKV
    cobas® BKV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV
    cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® liat system Diagnose and differentiate influenza A/B & RSV for effective clinical management and infection control with the POC multiplex PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CMV
    cobas® CMV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    <b>cobas</b><sup>®</sup> SARS-CoV-2
    cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® liat system Inform decisions at the POC with targeted RT-PCR SARS-CoV-2 test results in 20 minutes for both asymptomatic and symptomatic individuals using the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Strep A
    cobas® Strep A Nucleic acid test for use on the cobas® liat system With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® liat system aids clinicians to make immediate, informed treatment decisions.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HCV
    cobas® HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    Country Specific Labeling See country-specific product labeling for regulatory status.
    cobas® eplex RP 2 panel
    cobas® eplex respiratory pathogen panel 2
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Gram-Negative panel
    cobas® eplex blood culture identification gram-negative (BCID-GN) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Fungal Pathogen panel
    cobas® eplex blood culture identification gram-positive (BCID-GP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Fungal Pathogen (BCID-FP) panel
    cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Cdiff
    cobas® Cdiff Nucleic acid test for use on the cobas® liat system Provide accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff with the POC PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B
    cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® liat system Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup> eplex</b> system
    cobas® eplex system The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
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