Intended Use
The kit is intended for professional use for the qualitative and semiquantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum or plasma and to determine the avidity of IgG antibodies. The test is also useful in the diagnosis of VZV-associated diseases, namely varicella and herpes zoster. The test can also be utilized for the differential diagnosis of neuroinfections (encephalitis, meningitis, cerebellitis, vasculitis, myelitis and inflammatory neuropathies), infections of the eye and of exanthematous diseases of the skin. The kit is intended for differentiation of primary and recurrent VZV infection. Primary infection induces mainly low avidity (bind with low affinity) IgG antibodies to viral antigens. Later, antibodies with high avidity prevail. The predominance of low avidity IgG antibodies indicates recent primary infection. In other words, individuals with predominance of high avidity antibodies underwent the primary infection in the past. If such individuals have the symptoms of active VZV infection, it usually means the reactivation of the infection.
Contents of Kit
1. ELISA break-away strips in the handling frame coated with the specific antigen STRIPS Ag, 1 × 12 pcs
2. 1.3 mL of positive control human serum containing high avidity antibodies (High avidity control serum) r.t.u.1) HIGH AVID, 1 vial
3. 1.3 mL of positive control human serum containing low avidity antibodies (Low avidity control serum) r.t.u. LOW AVID, 1 vial
4. 1.3 mL Standard A = Negative control human serum, r.t.u. ST A/NC, 1 vial
5. 2.0 mL Standard D = Calibrator (human serum), r.t.u. ST D/CAL, 1 vial
6. 1.3 mL Standard E = Positive control human serum, r.t.u. ST E/PC, 1 vial
7. 13 mL Anti-human IgG animal antibodies labelled with horseradish peroxidase (anti-IgG Px conjugate) r.t.u. CONJ, 1 vial
8. 55 mL Wash buffer, 10× concentrated WASH 10×, 1 vial
9. 60 mL Dilution buffer, r.t.u. DIL, 1 vial
10. 13 mL Chromogenic substrate TMB, r.t.u. (TMB/H2O2), TMB 1 vial
11. 13 mL Urea solution, r.t.u. UREA, 1 vial
12. 13 mL Stop solution, r.t.u. (0.4 M sulfuric acid) STOP, 1 vial
13. Instruction manual
14. Quality Control Certificate
1) r.t.u., ready to use
Notice: Control sera may be colorless to yellowish or blue due to the use of different diluents.
Performance Characteristics
Validity of the test
The absorbance value of the Dilution buffer DIL (BLANK = reaction background) is stated in the Quality Control Certificate of the lot.
The OD values of the standards / control sera and the ratio of the OD values of the standards ST E/PC / ST D/CAL should be within the ranges stated in the Quality Control Certificate of the lot.
The Calibrator and Controls are human sera, and as such they may show inhomogeneity, if their value in the test is significantly different from the values stated in the Certificate of analysis, consult the results with the manufacturer.
Precision
The interassay variability (between tests) and the intraassay variability (within the test) were determined by testing samples with different OD values.
1. Repeatability (intraassay) The variation coefficient of intraassay is max. 8 %. It is measured for each particular lot at least on 12 parallels of the same microtiter plate.
2. Reproducibility (interassay) The variation coefficient of reproducibility is a maximum of 15 %. It is measured for each lot by comparing the wells of the same sample in several consecutive tests.

Detection Range
The measuring range is determined by the measuring capability of the spectrophotometer / colorimeter used.
Sensitivity
Sensitivity and specificity of the testThe evaluation of the diagnostic sensitivity and the specificity of the test was performed by the comparing the kit with two other commercial ELISA tests and with indirect immunofluorescence test.

* Equivocal results were not taken in account for calculation
a. Analytical sensitivity of the test The analytical sensitivity of the assay is defined as the mean of the sample without analyte plus three times of the standard deviation and represents the lowest detectable antibody titer. The analytical sensitivity value is determined for each kit lot and is stated in the Quality Control Certificate of that kit lot.
b. Analytical specificity of the test The quality of the native antigen VZV, which recognizes specific antibodies in patient samples, ensures the high specificity and sensitivity of this assay. However, to determine the diagnosis, the test results must always be interpreted in the context of clinical signs and the results of other laboratory tests, see Interpretation Of Results.
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