Rubella IgG ELISA Kit

INTENDED USE

Human rubella IgG ELISA kit is a method intended for analysing in-vitro levels of human IgG antibodies against rubella virus (rubella IgG) virus in samples of serum and plasma. This assay has a minimum analytical sensitivity limit of 0.38 IU/ml.

BACKGROUND

Rubella virus belongs to the family Togaviridae, it is between 40-80 nm, single-stranded, positive-sense, spherical RNA virus which contains hemagglutinin surface projections. It is made up of three major structural polypeptides and is the only serotype which has been identified. It is also known as German measles) is a common mild disease that can be characterised by a rash, it can be transmitted through direct or droplet contact with respiratory secretions. When it infects susceptible women during the early of pregnancy, it can be transmitted to the fetus which could lead to possible birth defects. In general, it is found to affects children and adolescents throughout the worldwide, it can also affect young adults.

Laboratory methods which can be used to detecting rubella include ELISA assays, hemagglutination inhibition test (HIT) and hemolysis-in-gel test. The IgG test is helpful in determining immunity, whereas virus-specific IgM antibodies detection is crucial in measuring a fresh infection.

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.

• Rubella Antigen Coated Microtiter Strips
• Calibrators (A-E): 0, 10, 50, 200, 500 IU/mL.
• Enzyme Conjugate.
• TMB Substrate.
• Stop Solution.
• Sample Diluent.
• Washing Buffer (10x)
• Plastic Foils
• Plastic Bag (x2).

SENSITIVITY

The minimum detection sensitivity level of human IgG antibodies to rubella virus (rubella-IgG) using current rubella-IgG ELISA kit was 0.38 IU/ml. The dynamic range for this assay is 0 – 500 IU/ml.

ASSAY CHARACTERSTICS

– Intra-Assay-Precision: 4.3 – 7.2 %
– Inter-Assay-Precision: 2.6 – 17.0 %
– Inter-Lot-Precision: 5.3 – 23.2 %
– Recovery: 102 – 118 %
– Linearity: 75 – 110 %
– Cross-Reactivity: No cross-reactivity to herpes 1, cytomegaly, toxoplasma, dsDNA, measles, mumps, varicella and EBV-VCA.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 g/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Investigation into low-level anti rubella virus IgG results reported by commercial immunoassays. Clin Vaccine Immunol. (2013) 20 (2): 255-61. Dimech W., et al.
2. Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies. Clin Microbiol Rev. (2016) 29 (1): 163-74. Review. Dimech W., et al.
3. Prevalence of rubella-specific IgG antibodies in unimmunized young female population. J Family Med Prim Care. (2016) 5 (3): 658-662. Thayyil J., et al.
4. Maturation of rubella IgG avidity over time after acute rubella infection. Clin Diagn Virol. (1997) 8 (2): 105-11. Böttiger B. and Jensen I.P.
5. Placental transfer of rubella specific_IgG in fullterm and preterm newborns. Int J Gynaecol Obstet. (2003) 81 (2): 157-62. Doroudchi M., et al.

ADDITIONAL INFORMATION

• Full Name: Rubella IgG ELISA Kit
• Reactivity: Human
• Sample Type: Serum, Plasma
• Sensitivity: 0.38 IU/ml

OTHER RELATED ELISA KITS

• Rubella-IgM ELISA Kit
• CMV-IgG ELISA Kit
• Toxoplasma-IgG ELISA Kit

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