Rubella IgM ELISA Kit

Full Name: Rubella IgM ELISA Kit
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: 1.34 U/ml

BACKGROUND

Rubella virus is a single stranded, spherical, positive-sense RNA virus that is a member of the Togaviridae family. It consists of three major structural polypeptides and many hemagglutinin containing surface projections. It can be transmitted via droplet or direct contact with respiratory secretions and is also commonly referred to as German measles that is characterised by a specific rash. It mainly affects children or adolescents throughout the worldwide but can also affect young adults.

Rubella virus can infect susceptible pregnant women during the early stages of pregnancy and this can lead to potential birth defects to the fetus. Common methods used for detection include hemolysis-in-gel test, ELISA assays and hemagglutination inhibition test (HIT). Virus specific IgM antibodies are important to determining fresh infections whereas IgG tests are useful in measuring immunity.

INTENDED USE

Human rubella IgM ELISA kit can be used for determining in-vitro amounts of human IgM antibodies to rubella virus (rubella IgM) in plasma and serum samples. This assay has a minimum analytical sensitivity limit of 1.34 U/ml.

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.

• Rubellavirus Antigen Coated Microtiter Strips.
• Calibrators (A-D): 1, 10, 30, 90 IU/mL.
• Enzyme Conjugate.
• TMB Substrate.
• Sample Diluent.
• Washing Buffer (10x).
• Stop Solution.
• Plastic Foils.
• Plastic Bag (x2).

SENSITIVITY

The minimum detection sensitivity level of human IgM antibodies to rubella virus (rubella-IgM) using current rubella-IgM ELISA kit was 1.34 U/ml. The dynamic range for this assay is 1 – 90 U/ml.

ASSAY CHARACTERSTICS

– Intra-Assay-Precision: 6.5 – 9.2 %
– Inter-Assay-Precision: 1.8 – 33.2 %
– Inter-Lot-Precision: 0.8 – 30.9 %
– Recovery: 75 – 86 %
– Linearity: 78 – 118 %
– Cross-Reactivity: No cross-reactivity to EBV-VCA, dsDNA, cytomegaly, mumps, measles, herpes 1, varicella and toxoplasma.
– 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. Kinetics of rubella-specific IgM antibody response in postnatal rubella infection. J Virol Methods. (1991) 34 (1): 37-43. Cordoba P., et al.
2. Evaluation of rubella IgM enzyme immunoassays. J Clin Virol. (2004) 30 (3): 233-8. Tipples G.A., et al.
3. Solid phase anti-IgM ELISA for detection of rubella specific IgM antibodies. Acta Pathol Microbiol Scand B. (1981) 89 (2): 123-8. Vejtorp M.
4. Evaluation of a commercial rubella IgM assay for use on oral fluid samples for diagnosis and surveillance of congenital rubella syndrome and postnatal rubella. J Clin Virol. (2006) 37 (4): 265-8. Vijaylakshmi P., et al.
5. Detection of IgM antibodies against rubella virus: comparison of two indirect ELISAs and an anti-IgM capture immunoassay. J Med Virol. (1986) 19 (4): 377-86. Enders G. and Knotek F.

OTHER RELATED ELISA KITS

• Rubellavirus IgG ELISA Kit
• Toxoplasma IgM ELISA Kit
• CMV IgM ELISA Kit