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Elecsys® HSV-2 IgG

Immunoassay for the qualitative determination of IgG-antibodies to Herpes Simplex Virus type 2

Elecsys® HSV-2 IgG

Immunoassay for the qualitative determination of IgG-antibodies to Herpes Simplex Virus type 2

Herpes Simplex Virus 2 (HSV-2) is mainly sexually transmitted, causing genital herpes. The global prevalence of HSV-2 infection is estimated to be 11.3 %, but can be higher in specific risk groups like AIDS-patients and female sex workers1. HSV-2 infection is a risk factor for HIV transmission and is associated with an increased risk of acquisition of HIV.2

Neonatal herpes, which can be caused by HSV‑2 as well as HSV‑1, has the most severe implications and is usually acquired during the intrapartum period through exposure in the genital tract2. Subclinical viral shedding and unrecognized infections seem to be major factors in transmission.1 Genital HSV infection is frequently not recognized and diagnosis based on the clinical presentation alone has a low sensitivity.2

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 identification of silent carriers of HSV-2 infection in patients with or without pre-existing antibodies to HSV-1 3,4,5. Type-specific serology should guide testing and result interpretation. This is important for a proper development of strategies to prevent transmission to partners and neonates, counselling, and management of the disease.6 IgM testing is not recommended in routine clinical practice6.

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Elecsys® HSV-2 IgG

Elecsys® HSV-2 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 <0.51 = non-reactive
    ≥0.51 – <1.0 COI = 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 1.3 %      
    cobas e 402 / cobas e 801 analytical units: CV 2.7 %

     

     

  • Relative sensitivity

    Sexually active adults: 98.4 % (n = 300)
    Sexually active adults: 100 % (n = 300)
    Pregnancy screening: 92.6 % (n = 400)
    Request for herpes testing: 100 % (n = 100)    

     

  • Relative specificity

    Sexually active adults: 100 % (n = 300)
    Sexually active adults: 99.6 % (n = 300)
    Pregnancy screening: 99.7 % (n = 400)
    Request for herpes testing: 98.7 % (n = 100)    

     

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    References

    1. Looker KJ, et al. Global Estimates of Prevalent and Incident Herpes Simplex Virus Type 2 Infections in 2012. PLoS ONE 2015; 10(1): e114989. 
    2. 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.
    3. Boggess KA, et al. Herpes simplex virus type 2 detection by culture and polymerase chain reaction and relationship to genital symptoms and cervical antibody status during the third trimester of pregnancy. Am J Obstet Gynecol. 1997; 176(2):443-451.
    4. Brown ZA, et al. Genital Herpes Complicating Pregnancy. Obstet Gynecol. 2005;106:845–56.
    5. 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.
    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-2 IgG (#08948887190, #08948909190) method sheet 2022, V. 1.0..