CMV IgG ELISA Kit (Cytomegalovirus)

INTENDED USE

Human CMV IgG ELISA kit is intended for analysing in-vitro levels of human IgG antibodies to cytomegalovirus (CMV, CMV IgG) in plasma or serum samples. This assay has a minimum analytical sensitivity limit of 1.29 U/ml.

BACKGROUND

Cytomegalovirus (CMV) are described as herpesvirus infections, which can transfected through blood, saliva, urine, breast milk, vaginal fluids and sperm. If a person becomes infected then this virus can remain inactive within their body throughout their life. Infants which are born to mothers that are infected during pregnancy could develop congenital infection.

Individuals that have a weak immune system are prone to the virus causing serious diseases/illnesses such as hepatitis, pneumonia, retinitis, encephalitis or colitis). However, currently there are no vaccines that are commercially available. Some of the laboratory techniques that have been used to study this virus are CF and ELISA methods. Serologically either IgG or IgM antibodies can be determined and quantitated, as well as the avidity of the IgG molecules can be measured.

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.

• Cytomegalovirus antigen coated microtiter strips.
•  Calibrator A (Negative Control).
• Calibrator B (Cut-Off Standard).
• Calibrator C (Weak Positive Control).
• Calibrator D (Positive Control).
• Enzyme Conjugate.
• TMB Substrate.
• Stop Solution.
• Sample Diluent.
• Washing Buffer (10x).

SENSITIVITY

The minimum detection sensitivity level of of human IgG against cytomegalovirus (CMV-IgG) using current CMV IgG ELISA kit was 1.29 U/ml. The dynamic range for this assay is 1.0 – 90.0 U/ml.

ASSAY CHARACTERSTICS

– Intra-Assay-Precision: 9.6 – 12.2 %
– Inter-Assay-Precision: 4.4 – 15.4 %
– Inter-Lot-Precision: 4.0 – 30.6 %
– Analytical Sensitivity: 1.29 U/mL
– Recovery: 103 – 123 %
– Linearity: 78 – 130 %
– Cross-Reactivity: No cross-reactivity to herpes 1, rubella, toxoplasma, measles, mumps, varicella, parainfluenza and EBV-VCA. Interferences of dsDNA IgG, TG IgG and TPO IgG positive samples or samples of donors suffering from an acute EBV infection cannot totally be excluded.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 mg/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 98 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Performance of a cytomegalovirus IgG enzyme immunoassay kit modified to measure avidity. Clin Vaccine Immunol. (2014) 21 (6): 808-12. Prince H.E., et al.
2. Improvement of cytomegalovirus avidity testing by adjusting the concentration of CMV-specific IgG in test samples. J Clin Virol. (2006) 35 (3): 303-9. Dangel V., et al.
3. Detection of human cytomegalovirus-IgG antibody using automated immunoassay with recombinant antigens gives uniform results to established assays using whole virus antigens. Pathology. (2010) 42 (6): 578-80. Baalawi F., et al.
4. Evaluation of a novel array-based toxoplasma, rubella, cytomegalovirus, and herpes simplex virus IgG enzyme linked immunosorbent assay and its comparison with virion/serion enzyme linked immunosorbent assays. Ann Lab Med. (2014) 34 (1): 38-42. Wu D., et al.
5. IgG subclass antibodies to human cytomegalovirus (CMV) in normal human plasma samples and immune globulins and their neutralizing activities. Biologicals. (1996) 24 (2): 117-24. Gupta C.K., et al.

ADDITIONAL INFORMATION

• Full Name: CMV IgG ELISA Kit (Cytomegalovirus)
• Reactivity: Human
• Sample Type: Plasma, Serum
• Sensitivity: 1.29 U/ml

OTHER RELATED ELISA KITS

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

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