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Elecsys® HSV-1 IgG

Immunoassay for the qualitative determination of IgG-antibodies to Herpes Simplex Virus type 1

Elecsys® HSV-1 IgG

Immunoassay for the qualitative determination of IgG-antibodies to Herpes Simplex Virus type 1

Herpes Simplex Virus 1 (HSV-1) is mainly transmitted by oral-to-oral contact during childhood, but also sexually later in life.1 The global prevalence of HSV-1 infection is estimated to be 67%, with highest prevalence in Africa, South-East Asia and Western Pacific.1

A primary infection with HSV is often associated with the development of painful watery blisters that release an infectious exudate. Typical sites are the mouth, lips (herpes labials) or genitals (herpes genitalis).2 Recurrent skin lesions are the hallmark of HSV pathogenesis.

Orofacial herpes manifestations are usually caused by HSV-1, whereas genital herpes is mainly caused by HSV-2.2 However, the new estimates highlight that HSV-1 is also an important cause of genital herpes.2 HSV-1 and HSV-2 can also be transmitted vertically before birth or perinatally during delivery.1 Such infections may have severe, if not fatal, consequences for the fetus/newborn.1 Subclinical viral shedding and unrecognized infections seem to be major factors in transmission, therefore laboratory tests are key for a correct diagnosis.

Type-specific serologic tests for the detection of IgG, based on the use of recombinant HSV-1 glycoprotein G (gG1) and the recombinant HSV-2 glycoprotein G (gG2), allow the distinction between HSV-1 and HSV-2.3,4 This is important for a proper development of strategies to prevent transmission to partners and neonates, counselling, and management of the disease. IgM testing is not recommended in routine clinical practice.4,5,6

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Elecsys® HSV-1 IgG

Elecsys® HSV-1 IgG

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    Double antigen sandwich assay    

  • Calibration

    2-point

  • Interpretation

    COI <0.6 = non-reactive
    0.6≤ COI <1.0 = gray zone
    COI ≥1.0 = reactive    

  • Traceability

    This method has been standardized against a Roche standard (arbitrary units) 

  • Sample material

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: Serum collected using standard sampling tubes or tubes containing gel. Li-heparin K2-EDTA and K3-EDTA plasma. 

    cobas e 801 module: Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, K2-EDTA and K3-EDTA plasma. Li-heparin plasma tubes containing separating gel can be used    

  • Sample volume

    20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    12 μL cobas e 801 module

  • Onboard stability

    28 days for cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks for cobas e 801 module

  • Intermediate precision

    cobas e 411 analyzer: CV 2.5 – 2.9 %       
    cobas e 601 / 602 modules: CV 2.2 %      
    cobas e 801 module: CV 1.7 – 2.4 %

  • Relative sensitivity

    Sexually active adults: 99.4 % (n = 300)
    Sexually active adults: 99.4 % (n = 300)
    Pregnancy screening: 95.6 % (n = 400)
    Request for herpes testing: 100 % (n = 100) 

  • Relative specificity

    Sexually active adults: 100 % (n = 300)
    Sexually active adults: 97.6 % (n = 300)
    Pregnancy screening: 100 % (n = 400)
    Request for herpes testing: 100 % (n = 100) 

     

References

 

  1. WHO (2017). Herpes simplex virus. in Media centre. Fact sheets, accessed November 2017.
  2. Looker, K.J. et al. (2015). Plos One 10, e0140765.
  3. Brown, et al. (2005). Obstet Gynecol 106, 4, 845-56.
  4. https://www.cdc.gov/std/tg2015/herpes.htm, accessed November 2017.
  5. Strick, L. et al. (2004). Expert Review of Molecular Diagnostics 4, 443-453.
  6. Patel, R. et al. (2017). Int J STD AIDS 28, 14, 1366-1379.