Mycoplasma pneumoniae IgM ELISA Kit

Sample

Serum and Plasma

Species Reactivity

Human

Detection Method

ELISA

Intended Use

The Mycoplasma pneumoniae IgM tests are quantitative and qualitative immunoassays for the detection of human antibodies, directed against Mycoplasma pneumoniae, in serum or plasma. The Mycoplasma pneumoniae IgM allows for sensitive detection of acute (primary) infections, especially in children and adolescents.

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 IgM 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

Sensitivity: > 91.3 %
Specificity: > 95.5 %
Reproducibility:

Detection Range

The borderline ranges of the Mycoplasma pneumoniae 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.