Milk Allergen Specific IgE Antibody ELISA Kit

Sample

Serum

Species Reactivity

Human

Detection Method

ELISA

Intended Use

This kit is intended for the quantitative detection of milk allergen-specific IgE antibody levels in human serum.
In recent decades, the number of allergic individuals has been increasing worldwide. The concept of allergy generally refers to Type I hypersensitivity (immediate hypersensitivity), which typically triggers symptoms within 30 minutes of allergen exposure. The most common symptoms include: fever (rhinitis), sandy eyes (conjunctivitis), measles (rubella), allergic asthma, and other dangerous allergic reactions (anaphylactic shock).
Allergens causing Type I hypersensitivity are mostly proteins from the natural environment, such as plant pollen, animal dander, food, dust mites, and insect venom. A notable characteristic of Type I hypersensitivity is the binding of allergens to specific immunoglobulin E (sIgE); therefore, detection of sIgE has become an important means of allergy diagnosis.
This reagent is not recommended for health screening of the general population. Positive or negative test results only represent the presence or absence of the corresponding IgE antibody and do not definitively correlate with disease status.

Contents of Kit

1. Anti-IgE antibody-coated microplate: 1×96, Anti-IgE antibody coated on microplate wells
2. Horseradish peroxidase-streptavidin conjugate: 1×16 mL, Horseradish peroxidase-streptavidin dissolved in buffer
3. Concentrated wash buffer (25×): 1×50 mL, Tween dissolved in phosphate buffer
4. Substrate solution (TMB): 1×16 mL, Tetramethylbenzidine dissolved in buffer
5. Stop solution (0.5 M H₂SO₄): 1×16 mL, 0.5 M H₂SO₄
6. Milk allergen-biotin: 4×2.8 mL, Milk allergen-biotin dissolved in buffer

Storage

1. Store at 2–8°C. Shelf life: 15 months.
2. Production date and expiration date: see label.
3. All reagents should be stored at 2–8°C when not in use. Avoid repeated opening of packaging. Unused microplate strips should be returned to the foil bag and sealed together with the desiccant.

Performance Characteristics

Reference materials: Negative enterprise reference materials all yield results <0.35 IU/mL; limit of detection reference materials show >90% detection rate; repeatability reference materials have CV <±15%; linearity reference materials show r >0.99 after serial dilution.
Limit of detection: Not greater than 0.35 IU/mL.
Precision: Negative reference materials and limit of detection reference materials were tested over 20 days for intra-batch, inter-batch, intra-day, and inter-day statistics. Precision for negative reference materials is not greater than 30%; precision for limit of detection reference materials is not greater than 15%.
Intra-batch: Coefficient of variation CV ≤15%.
Inter-batch: Coefficient of variation CV ≤15%.
Accuracy: Testing of 50 clinical serum samples showed all results within the expected range.

Detection Range

In clinical diagnosis, extensive clinical studies have demonstrated that 0.35 IU/mL can serve as the cutoff for positive/negative determination in specific allergy testing. This study evaluated hundreds of clinical serum samples, and the 0.35 IU/mL reference interval is commonly used as the boundary between normal and abnormal values, typically employing a 95% confidence interval.