Sample
Serum, Plasma and Cerebrospinal Fluid.
Intended Use
The Influenza A IgM tests are quantitative and qualitative immunoassays for the detection of human antibodies in serum or plasma directed against conserved nucleo- and matrix proteins of Influenza A Viruses. The Influenza A IgM tests are recommended for the sensitive detection of acute infections, particularly in children.
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 IgG 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 Influenza A Virus IgM test was validated by the analysis of 105 serum samples from healthy blood donors and 76 samples from patients with suspected Influenza Virus infection. The ELISA of a European manufacturer was used as a reference. Sera classified as borderline were not included in the calculation.
Sensitivity: > 95.2 %
Specificity: > 98.5 %
Reproducibility:
Detection Range
The borderline ranges of the Influenza A 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.
Citations
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