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

Elecsys® HSV-1 IgG

Elecsys® HSV-1 IgG7

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

  • 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

    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 402 / cobas e 801 analytical units

  • Onboard stability

    28 days for cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks for cobas e 402 / cobas e 801 analytical units

  • Intermediate precision

    cobas e 411 analyzer: CV 1.9 %       
    cobas e 601 / 602 modules: CV 3.0 %      
    cobas e 402 / cobas e 801 analytical units: CV 2.3 %

  • 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. World Health Organization. Herpes simplex virus: Fact sheet [Internet; updated 2022 March; cited 2022 Oct 24]. Available from:https://www.who.int/news-room/fact-sheets/detail/herpes-simplex-virus.
  2. Looker KJ, et al. Global Estimates of Prevalent and Incident Herpes Simplex Virus Type 1 Infections in 2012. PLoS ONE 2015; 10(1): e0140765.
  3. Brown ZA, et al. Genital Herpes Complicating Pregnancy. Obstet Gynecol. 2005;106:845–56.
  4. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Infections Treatment Guidelines, 2021 - Genital Herpes. [Internet; updated 2021 Sept; cited 2022 Oct 24]. Available from: https://www.cdc.gov/std/treatment-guidelines/herpes.htm.
  5. Sénat MV, et al. Prevention and management of genital herpes simplex infection during pregnancy and delivery: Guidelines from the French College of Gynaecologists and Obstetricians (CNGOF). European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018;224: 93–101.
  6. Patel R, et al. 2017 European guidelines for the management of genital herpes. Int J STD AIDS 2017;28(14):1366-1379.
  7. Elecsys® HSV-1 IgG (#08948844190, #08948852190) method sheet 2022, V. 1.0..