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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

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Intended Use

The cobas® HIV-1/HIV-2 Qualitative nucleic acid test 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 (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.

 

cobas® HIV-1/HIV-2 Qualitative 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 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. 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.

 

 

 

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)
IVD For in vitro diagnostic use.
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