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cobas® Plasma Separation Card

cobas® Plasma Separation Card

Redefine the reach of reliable testing

As the world’s leading provider of HIV viral load testing, Roche is committed to increasing access to reliable HIV testing.

The cobas® Plasma Separation Card is a stable and easy-to-use sample collection device for HIV plasma viral load, simply spot a small amount of blood on the card, transport to a lab where HIV diagnostic tests can be performed. By providing a small amount of a patient’s blood from a fingertip, this specially designed card simplifies blood collection and sample transportation.

Innovation in HIV testing

cobas® Plasma Separation

The Card fundamentally changes the way plasma samples are taken and processed and allows for reliable quantitative testing of patients with HIV living in remote areas-even areas of extreme heat and humidity-while meeting WHO requirements for determining HIV viral load prior to setting treatment.

Intended use

 

cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma or from a cobas® Plasma Separation Card (PSC) dried plasma spot of HIV-1-infected individuals.

This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1-infected patients. This test can be used for confirmation of HIV-1 infection in antibody reactive individuals and to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.

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Registration status

CE-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

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Related information

Performance cobas® 6800/8800 Systems

  • Sample types

    Dried plasma spot coming from Plasma Separation Card

  • Minimum amount of sample required

    140 μL whole blood

  • Sample processing volume

    850 μL

  • Analytical sensitivity

    790.2 cp/mL

  • Linear range

    790 cp/mL - 1.07 cp/mL

  • Specificity

    100% (one-sided 96% confidence interval 98.3%)

Performance cobas® 4800 System

  • Sample types

    Dried plasma spot coming from Plasma Separation Card

  • Minimum amount of sample required

    140 μL whole blood

  • Sample processing volume

    400 μL

  • Analytical sensitivity

    598.6 cp/mL

  • Linear range

    599 cp/mL - 1.07 cp/mL

Performance COBAS® AmpliPrep/COBAS® TaqMan® System

  • Sample type

    Dried plasma spot coming from Plasma Separation Card

  • Minimum amount of sample required

    140 μL whole blood

  • Sample processing volume

    850 μL

  • Analytical sensitivity

    737.9 cp/mL

  • Linear range

    738 cp/mL - 1.07 cp/mL

  • Specificity

    99.4% (95% confidence interval ≥97.07%)

Transportation: Up to 28 days at 18-45°C and up to 85% humidity

Post transportation storage at room temperature (18-30°C), at 2-8°C or at -10°C for up to 56 days (with and without layer separation)

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