CMV IgM ELISA Kit (Cytomegalovirus)

Full Name: CMV IgM ELISA Kit (Cytomegalovirus)
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: 1.14 U/ml

BACKGROUND

Cytomegalovirus (CMV) are herpesvirus infections that can display many symptoms and are easily spread through non-sexual and sexual contact with body secretions. These infection can frequently develop in people who receive an infected organ transplant or transfusion of infected blood. The fetus of an infected pregnant woman may also acquire this infection during the pregnancy or even at the time of delivery.

The virus tends to infect the retina of the eye, brain (encephalitis), pneumonia or even painful ulcers of the oesophagus and the intestine may develop. Blood tests can be carried out to detect antibodies to CMV, this will only confirm new infections but cannot confirm if a disease is due to reactivation of the virus (majority of cases for people with weak immune systems). Cytomegalovirus-retinitis can be confirmed by an ophthalmologist and in newborns, the favoured option for the diagnosis is by culturing the urine.

INTENDED USE

Human CMV IgM ELISA kit is intended for detecting in-vitro amounts of human IgM antibodies to cytomegalovirus (CMV, CMV-IgM) using serum or plasma samples. This assay has a minimum analytical sensitivity limit of 1.14 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.

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

SENSITIVITY

The minimum detection sensitivity level of human  IgM against cytomegalovirus (CMV-IgM) using current CMV IgM ELISA kit was 1.29 U/ml. The dynamic range for this assay is 1.0 – 120.0 U/ml.

ASSAY CHARACTERSTICS

– Intra-Assay-Precision: 9.9 – 13.8 %
– Inter-Assay-Precision: 2.7 – 26.6 %
– Inter-Lot-Precision: 1.2 – 22.7 %
– Analytical Sensitivity: 1.14 U/mL
– Recovery: 100 – 110 %
– Linearity: 72 – 117 %
– Cross-Reactivity: No cross-reactivity to rubella, parainfluenza, measles, herpes 1, mumps, toxoplasma, EBV-VCA and varicella.
– Interferences: No interferences.
– Clinical Specificity: 98 %
– Clinical Sensitivity: 100 %

REFERENCES

1. Dual-labeled time-resolved immunofluorometric assay for the determination of IgM antibodies to rubella virus and cytomegalovirus in human serum. Clin Biochem. (2015) 48 (9): 603-8. Zhou J.W., et al.
2. Maternal IgM antibody status in confirmed fetal cytomegalovirus-infection detected by sonographic signs. Prenat Diagn. (2012) 32 (9): 817-21. Goncé A., et al.
3. Development of a new cytomegalovirus (CMV) immunoglobulin M (IgM) immunoblot for detection of CMV-specific IgM. J Clin Microbiol. (1998) 36 (11): 3337-41. Lazzarotto T., et al.
4. Comparison of five CMV IgM immunoassays with CMV IgG avidity for diagnosis of primary CMV infection. Pathology. (2012) 44 (4): 381-3. BaAlawi F., et al.
5. Positive Epstein-Barr virus and cytomegalovirus IgM assays in primary HIV infection. J Med Virol. (2011) 83 (8): 1406-9. Post J.J., et al.

OTHER RELATED ELISA KITS

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