Intended Use
Enzyme immunoassay for the quantitative determination of IgG-class antibodies against Rubella Virus in human serumor plasma (citrate, heparin).
Contents of Kit
1. Rubella Virus Coated Microplate (IgG): 12 break apart 8-well snap-off strips coated with Rubella Virus antigens; in resealable aluminium foil.
2. IgG Sample Diluent: 1 bottle containing 100 ml of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; colored yellow; ready to use; white cap.
3. Stop Solution: 1 bottle containing 15 ml sulphuric acid, 0.2 mol/l; ready to use; red cap.
4. Washing Buffer (20× conc.): 1 bottle containing 50 ml of a 20-fold concentrated phosphate buffer (0.2 M), pH 7.2 ± 0.2, for washing the wells; white cap.
5. Rubella Virus anti-IgG Conjugate: 1 bottle containing 20 ml of peroxidase labelled antibody to human IgG in phosphate buffer (10 mM); colored blue; ready to use; black cap.
6. TMB Substrate Solution: 1 bottle containing 15 ml 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1%; ready to use; yellow cap; < 5% NMP.
7. Rubella Virus IgG Standards: 4 vials, each containing 2 ml standard (human serum or plasma); colored yellow; ready to use.
Standard A: 0 IU/ml; blue cap
Standard B: 10 IU/ml; green cap
Standard C: 50 IU/ml; yellow cap
Standard D: 100 IU/ml; red cap.
The standards are calibrated in accordance with the WHO International Standard; Anti Rubella Immunoglobulin Human.
8. Cover foil: 1.
9. Instruction for use (IFU): 1.
10. Plate layout: 1.
For potential hazardous substances please check the safety data sheet.
Storage
Store the kit at 2 - 8°C. The opened reagents are stable up to the expiry date stated on the label when stored at 2 - 8°C.
Detection Range
0.45 IU/ml - 100 IU/ml
Sensitivity
1. Analytical Sensitivity
The analytical sensitivity (according to CLSI EP17-A) is defined as the apparent concentration of the analyte that can be distinguished from the zero calibrator. It is 0.45 IU/ml.
2. Diagnostic Specificity
The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 100.0% (95% confidence interval: 94.87% - 100.0%).
3. Diagnostic Sensitivity
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 100.0% (95% confidence interval: 97.72% - 100.0%).
General Description
Rubella is an enveloped RNA virus belonging to the toga viruses. It has a spherical shape measuring about 50-70 nm in diameter. There appears to be only one antigenic type, and no cross-reactivity with alpha viruses or other members of the toga virus group has been found. Rubella viruses are pathogens of the respiratory tract and transmitted mainly by droplet infection. Rubella is a worldwide common contagious disease with mild constitutional symptoms and a generalized rash. In childhood, it is an inconsequential illness, but when it occurs during pregnancy, there is a significant risk of severe damage to the foetus.
The risk of congenital rubella depends primarily on the month of pregnancy in which infection is acquired: overall, app. 16% of infants have major defects at birth following maternal rubella in the first 3 months of pregnancy. Congenital rubella infection may lead to a syndrome with single or multiple organ involvements, known as embryopathia rubeolosa. In some cases infection is inapparent but results in consequential damages as eye defects, deafness, growth retardation, and others. Naturally acquired immunity usually is long-lasting, but reinfection is possible due to decreasing levels of circulating antibodies. For immunization a vaccine containing live virus is used.
The presence of pathogen or infection may be identified by:
1. PCR
2. Serology: e.g. ELISA, Hemagglutination inhibition (HAI)
Citations
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