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Herpes Simplex 2 IgM ELISA Kit

INTENDED USE

Human HSV-2 IgM ELISA kit can be used for measuring in-vitro quantitative concentrations of human IgM antibodies to herpes simplex virus 2 (HSV-2 IgM) in plasma or serum. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Herpes simplex virus type 2 (HSV-2) is a common genital herpes which is usually transmitted through sexual activity or by any skin-on-skin contact with an open sore. HSV-2 can spread through the secretions from the mouth or the genitals and it is highly contagious. Blood tests are routinely used for the diagnosis of these infections by identifying antibodies to HSV-1 and HSV-2. However, the “gold standard” for diagnosis of HSV infection remains to be isolation of the virus from tissue culture.

HSV-2 IGM ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Herpes Simplex 2 antigen coated microtiter strips.
  • Sample Diluent.
  • Enzyme Conjugate.
  • TMB Substrate.
  • Calibrator D (Positive Control).
  • Calibrator A (Negative Control).
  • Calibrator B (Cut-Off Standard).
  • Calibrator C (Weak Positive Control).
  • Washing Buffer (10x).
  • Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of IgM to herpes simplex virus 2 (HSV-2 IgM) using current human HSV-2 IgM ELISA kit was 1.0 U/ml. The dynamic assay range for this kit is 1.0 – 150.0 U/ml.

ASSAY CHARACTERSTICS

– Herpes Simplex 2 ELISA: IgM
– Intra-Assay-Precision: 7.1 %
– Inter-Assay-Precision: 9.4 %
– Inter-Lot-Precision: 3.3 – 10.6 %
– Analytical Sensitivity: 1.04 U/mL
– Recovery: 95 – 115 %
– Linearity: 77 – 130 %
– Cross-Reactivity: No cross-reactivity to Mumps, Measles and Varicella.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 mg/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 100 %

REFERENCES

  1. Herpes simplex virus-specific IgM, IgA and IgG subclass antibody responses in primary and nonprimary genital herpes patients. Microbiol Immunol. (1997) 41 (5): 415-20. Hashido M. and Kawana T.
  2. Evaluation of commercial herpes simplex virus IgG and IgM enzyme immunoassays. J Virol Methods. (2014) 199: 29-34. Liermann K., et al.
  3. Performance of a novel test for IgM and IgG antibodies in subjects with culture-documented genital herpes simplex virus-1 or -2 infection. Clin Microbiol Infect. (2006) 12 (5): 463-9. Morrow R. and Friedrich D.
  4. Characteristics of a shared idiotype by two IgM anti-herpes simplex virus monoclonal antibodies that recognize different determinants. J Immunol. (1983) 130 (4): 1943-6. Kennedy R.C., et al.

ADDITIONAL INFORMATION

  • Full Name: Herpes Simplex Virus 2 IgM ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.0 U/ml

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