cobas® HIV-1/HIV-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> HIV-1/HIV-2 Qualitative
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
Intended use

Intended use

cobas® HIV-1/HIV-2 Qualitative 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 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


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  • 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)

* Dead volume of 0.150 mL is identified for the cobas® omni Secondary Tubes. Other tubes compatible with cobas® 5800/6800/8800 Systems (consult User Assistance and/or User Guides) may have different dead volume and require more or less minimum volume.

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.


1. cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on cobas® 5800/6800/8800 Systems Instructions for Use: 09198695001.


Detailed Specifications

Ordering Information

Compatible Instruments


    Technical Documents

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