The kit is intended for professional use for the qualitative and semiquantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum and plasma and for the determination of intrathecal synthesis in cerebrospinal fluid. 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 detection of neuroinfections (encephalitis, meningitis, cerebellitis, vasculitis, myelitis and inflammatory neuropathies), infections of the eye and of exanthematous diseases of the skin.
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 Standard A = Negative control human serum, r.t.u. 1) ST A/NC, 1 vial 3. 1.3 mL Standard B (human serum), r.t.u. ST B, 1 vial 4. 1.3 mL Standard C (human serum), r.t.u. ST C, 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 Stop solution, r.t.u. (0.4 M sulfuric acid) STOP, 1 vial 12. Instruction manual 13. 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.
Storage
2°C - 10°C
Performance Characteristics
The kit is intended for the qualitative, semiquantitative and quantitative detection of anti-VZV IgG antibodies in human serum, plasma and cerebrospinal fluid. Suitable specimens are serum, plasma (heparinised) and cerebrospinal fluid samples obtained by standard laboratory techniques. 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. a. 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. b. 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.
Detection Limit
The limit of quantification is defined as the lowest measurable concentration that can be distinguished from zero with 95% confidence. This value is determined for each batch of the kit and is stated in the Quality Control Certificate of the given batch of the kit.
Sensitivity
Sensitivity and specificity of the test The evaluation of the diagnostic sensitivity and the specificity of the test was performed by the comparing the TEST 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).
Citations
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Background
Varicella zoster virus (VZV) is a human-specific alpha herpesvirus, belonging to the genus Varicella, which causes varicella (also known as chickenpox) and herpes zoster (also known as shingles). Chickenpox epidemics occurred annually in the United States until the introduction of the chickenpox vaccine in 1995, but epidemics are still prevalent among children in countries without immunization programs. Anyone who is first infected with the varicella zoster virus, which usually presents as varicella, can develop herpes zoster. Herpes zoster occurs when the varicella zoster virus, which causes varicella and herpes zoster, is reactivated from its latent state in the dorsal roots or cerebral ganglia and spreads to the skin via afferent nerves. The typical symptom of herpes zoster is the appearance of a zonal rash at the skin that affects the corresponding nerve. The most common rash involves the chest, followed by the skull (especially the trigeminal nerve), lumbar spine and neck.
Figure 1. Different phases of varicella zoster virus infection (Source: Kennedy PG, et al. 2020)
The clinical diagnosis of VZV is not obvious, and ancillary laboratory tests are needed to help the physician make a determination. Polymerase chain reaction (PCR) assay is the best method for detecting varicella zoster virus because it is highly sensitive and specific, convenient for obtaining results, and relatively quick (≤1 day) turnaround. Direct fluorescent antigen (DFA) assay is not as sensitive as PCR, and is used as a complementary tool when PCR is not available. Viral cultures are less sensitive than DFA and PCR and require several days to obtain results. Assessment of VZV serum antibody potency by serologic testing can determine the presence of immunity and thus guide the need for vaccination. Immunocompetent adults who are seronegative should receive varicella vaccine rather than herpes zoster vaccine. Serologic testing of individuals younger than 13 years of age is not recommended at this time, but it is suggested that serologic testing may be considered for individuals 13 years of age or older with no history of varicella.
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Primary care providers and hospitalists frequently encounter older or immunocompromised patients with herpes zoster accompanied by debilitating pain. Atypical presentations and zosteriform herpes simplex may present diagnostic challenges to clinicians. This article summarizes the background, evidence, and guidelines for the diagnosis, complications, treatment, and prevention of herpes zoster. Diagnosis of challenging cases relies on polymerase chain reaction as the preferred test. Treatment focuses on optimal use of antiviral therapy and analgesics. Prevention emphasizes utilization of a new recombinant zoster vaccine, which reduces the incidence of herpes zoster by more than 90% and is preferred to the live attenuated herpes zoster vaccine.
Infection with varicella zoster virus (VZV) causes varicella (chickenpox), which can be severe in immunocompromised individuals, infants and adults. Primary infection is followed by latency in ganglionic neurons. During this period, no virus particles are produced and no obvious neuronal damage occurs. Reactivation of the virus leads to virus replication, which causes zoster (shingles) in tissues innervated by the involved neurons, inflammation and cell death - a process that can lead to persistent radicular pain (postherpetic neuralgia). The pathogenesis of postherpetic neuralgia is unknown and it is difficult to treat. Furthermore, other zoster complications can develop, including myelitis, cranial nerve palsies, meningitis, stroke (vasculopathy), retinitis, and gastroenterological infections such as ulcers, pancreatitis and hepatitis. VZV is the only human herpesvirus for which highly effective vaccines are available. After varicella or vaccination, both wild-type and vaccine-type VZV establish latency, and long-term immunity to varicella develops. However, immunity does not protect against reactivation. Thus, two vaccines are used: one to prevent varicella and one to prevent zoster. In this Primer we discuss the pathogenesis, diagnosis, treatment, and prevention of VZV infections, with an emphasis on the molecular events that regulate these diseases. For an illustrated summary of this Primer, visit: http://go.nature.com/14xVI1.
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Figure 1. Different phases of varicella zoster virus infection
