Sample
Serum, Plasma and Cerebrospinal Fluid.
Intended Use
The Measles Virus IgM tests are quantitative and qualitative immunoassays for the detection of human antibodies in serum or plasma directed against Measles Virus. The Measles Virus IgM test is recommended for the determination of acute infections.
Contents of Kit
1.ELISA Microplate: 12 × 8
Break apart microtiter test strips each with eight antigen coated single wells.
The coating material is inactivated.
2.Standard serum (ready-to-use) 2 × 2 ml
Human serum in protein containing phosphate buffer; negative for anti-HIV Ab, HBsAg (Hepatitis B-Virus surface antigen) and anti-HCV Ab;
preservative: < 0.1 % sodium azide; colouring: Amaranth O.
3.Negative control serum (ready-to-use) 2 ml
Human serum in protein containing phosphate buffer; negative for anti-HIV Ab, HBsAg (Hepatitis B-Virus surface antigen) and anti-HCV Ab;
preservative: < 0.1 % sodium azide; colouring: Lissamin Green V.
4.Anti-human IgM conjugate (ready-to-use) 13 ml
Anti-human IgG polyclonal antibody, conjugated to alkaline phosphatase, stabilised with protein stabilisation solution;
preservative: < 0.1 % methylisothiazolone, < 0.1 % bromnitrodioxane.
5.Washing solution concentrate (sufficient for 1000 ml) 33.3 ml
Sodium chloride solution with Tween 20 and 30 mM Tris/HCl, pH 7.4;
preservative: < 0.1 % sodium azide.
6.Dilution buffer (ready-to-use) 2 × 50 ml
Protein containing phosphate buffer with Tween 20;
preservative: < 0.1 % sodium azide; colouring: 0.01 g/l Bromphenol blue.
7.Stopping solution (ready-to-use) 15 ml
< 0.1 N sodium hydroxide, 40 mM EDTA.
8.Substrate (ready-to-use) 13 ml
Para-nitrophenylphosphate in solvent free buffer;
preservative: < 0.1 % sodium azide.
Storage
The kit is stored at 2 - 8°C (Avoid Direct Light), and not be frozen or thawed. The product is valid for 12 months. After opening, store at 2 - 8°C, it can be stable for 6 months, avoid contamination.
Performance Characteristics
The Measles Virus IgM test was validated in an internal study by the analysis of 249 serum samples from blood donors, pregnant women and patients with suspected acute Measles Virus infection as well as with samples from interlaboratory tests. Two ELISA immunoassays of leading European manufacturers were used as reference tests. Borderline test results were not included into the calculation.
Sensitivity: > 98.9 %
Specificity: > 99 %
Reproducibility:

Detection Range
The borderline ranges of the Measles Virus IgM tests are specified on the quality control certificates and indicate the range of borderline test results. Values below this range indicate a negative test result; values above the borderline range are interpreted positive.
General Description
Measles Virus, in common with Mumps virus, Parainfluenza Viruses and RS Virus belongs to the family of paramyxoviridae and has a worldwide distribution. According to WHO estimates, one million individuals die as a consequence of Measles Virus infections every year. A number of countries, along with the WHO, had set themselves the goal of eradicating measles by a program of vaccination.
The highly contagious nature of the virus has ensured that the measles disease syndrome has long been established as a typical childhood infection. Before the introduction of vaccination the majority of children (95 – 98 %) had been infected by the age of ten. The epidemiology has changed since the widespread use of an effective vaccine was implemented and now cases of measles are more commonly seen in the late school and early adult age range.
Citations
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