cobas® HIV-1/HIV-2 Qualitative Test

Product image for cobas® HIV-1/HIV-2 Qualitative Test

Stay one step ahead, enable diagnosis as early as possible

Drive better decisions for a positive impact on patients’ lives

 

The cobas® HIV-1/HIV-2 Qualitative Test for use on the cobas® 6800/8800 Systems is the first automated nucleic acid test to enable differentiation between HIV-1 and HIV-2 infections, applying the clinically proven dual target design (gag and LTR) for HIV-1. During seroconversion studies in 25 commercially available panels, cobas® HIV-1/HIV-2 detects HIV on average one week earlier than serology. cobas® HIV-1/HIV-2 offers flexible testing features (plasma, serum, dried blood spots for early infant diagnosis), highest throughput and absolute automation with ready-to-use reagents.

  • Diagnose HIV positive patients as early as possible
  • Confidently treat patients based on HIV subtype infection
  • Reliably inform mothers that their child is not infected and eliminate concerns about HIV status

cobas® HIV-1/HIV-2 Qualitative ordering information

RMD_170707_cobas_HIV-1_HIV-2-Qualitative-ordering-Information_table

Intended use

 

The cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus (HIV) type 1 (HIV-1) and type 2 (HIV-2) in human serum, plasma, and dried blood spots (DBS).

The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2. 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. In infants born to HIV-infected mothers and who have maternal antibodies to HIV-1 or HIV-2, the presence of HIV nucleic acid is indicative of active infection. cobas® HIV-1/HIV-2 Qualitative may also be used to confirm HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens.

Registration status

CE-IVD

Package inserts

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

cobas® HIV-1/HIV-2 Qualitative

  • Sample types

    EDTA plasma, serum and dried blood spot (DBS)

  • Minimum amount of sample required

    650 µL for EDTA plasma and serum samples or one DBS sample (70 µL dried blood per spot) or

    1150 µL cobas® Specimen Pre-Extraction Reagent (SPER)

  • Sample processing volume

    500 µL for EDTA plasma and serum samples or 850 µL for DBS samples

  • Analytical sensitivity / Genotype inclusivity / Diagnostic sensitivity

    EDTA plasma  HIV-1M: 12.6 cp/mL HIV-2: 27.9 cp/mL

     

    Serum             HIV-1M: 12.1 cp/mL HIV-2: 23.4 cp/mL

     

    DBS                HIV-1M:  255 cp/mL HIV-2: 984 cp/mL

  • Specificity

    100% (one sided 95% confidence interval 99.5%) (EDTA plasma/serum)

    100% (one sided 95% confidence interval 99.5%) (DBS)

  • Groups/subtypes - inclusivity

    HIV-1M (A-D, F-H, J, K, CRF01_AE, CRF02_AG, CRF12_BF, CRF14_BG), HIV-1O, HIV-1N, HIV-2 (A and B)

Ready-to-use reagents loaded onto the cobas® 6800/8800 Systems are stored at appropriate temperatures and their expiration is monitored by the system. The system automatically prevents use of expired reagents.

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