cobas® HIV-1/HIV-2 Qualitative Test

Enable critical diagnosis as early as possible for improved patient care
Product image for cobas® HIV-1/HIV-2 Qualitative Test

Enable critical diagnosis as early as possible for improved patient care

The cobas® HIV-1/HIV-2 Qualitative Test for use on the cobas® 5800/6800/8800 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 studies1 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, highest throughput and absolute automation with ready-to-use reagents.

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

Related portfolios

Kontakta oss

Intended Use

Registration status

cobas® HIV-1/HIV-2 Qualitative Test for 5800/6800/8800 Systems: CE-IVD

cobas® HIV-1/HIV-2 Qualitative Test for 5800/6800/8800 Systems: US-IVD

Package inserts

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

References:

1. cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on cobas® 5800/6800/8800 Systems Instructions for Use: 08020655001-05EN

Ready-to-use reagents loaded onto the cobas® 5800/6800/8800 Systems are stored at appropriate temperatures and their expiration is monitored by the system. The system automatically prevents use of expired reagents.

CE-IVD

  • 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)

US-IVD

  • Sample types

    EDTA plasma and serum

  • Minimum amount of sample required

    650 µL 

  • Sample processing volume

    500 µL 

  • Analytical sensitivity / Genotype inclusivity / Diagnostic sensitivity

    EDTA plasma  HIV-1M: 12.8 cp/mL HIV-2: 35.4 cp/mL

     

    Serum             HIV-1M: 12.8 cp/mL HIV-2: 26.3 cp/mL

     

     

  • Specificity

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

  • 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)
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