Human Anti-Amb a 1 IgE ELISA Kit

Sample

Serum

Species Reactivity

Human

Detection Method

ELISA

Intended Use

This kit is intended for the quantitative detection of specific IgE antibodies against ragweed allergens Amb a 1 in human serum.

Contents of Kit

1. 1×96 Microplate coated with anti-IgE antibody (1.5~3.0 μg/mL anti-IgE antibody coated on the microplate)
2. 1×16 mL HRP-streptavidin conjugate solution (1:4000~1:20000 horseradish peroxidase-streptavidin dissolved in 0.05M Tris-HCl buffer, pH 7.2±0.3)
3. 1×50 mL Concentrated washing buffer (25x) (10% w/v Tween-20 dissolved in 0.03M phosphate buffer, pH 7.2±0.3)
4. 1×16 mL Substrate solution (TMB) (TMB dissolved in buffer, pH 3.55±0.2)
5. 1×16 mL Stop solution (0.5M H₂SO₄)
6. 4×2.8 mL ragweed allergen Amb a 1-biotin (ragweed allergen-biotin dissolved in 0.05M Tris-HCl buffer, pH 7.2±0.3)

Storage

Store at 2~8°C, with a validity of 15 months.
The production date and expiration date are indicated on the label.
After opening, the validity is 28 days when stored at 2~8°C.
All reagents should be stored at 2~8°C when not in use to avoid repeated opening of the packaging. Unused microplate strips should be placed back into the aluminum foil bag, sealed, and stored with the desiccant.
Do not use expired kits.

Performance Characteristics

1. Reference samples: The detection results of negative enterprise reference samples are all less than 0.35 IU/ml; the detection rate of the limit of detection reference samples is more than 90%; the CV of the repeatability reference samples is less than ±15%; after serial dilution of the linearity reference samples, the detection linearity r value is greater than 0.99.
2. Lower limit of detection: Not more than 0.35 IU/ml.
3. Precision: For negative reference samples and lower limit of detection reference samples, statistics were performed for 20 days within batches, between batches, within days, and between days. The precision of negative reference samples is not higher than 30%, and the precision of the lower limit of detection is not higher than 15%.
4. Linear range: High-value samples were serially diluted to at least 5 concentrations, and the linear correlation coefficient r > 0.9900 was obtained after detection and fitting within the concentration range of 0-100 IU/mL.
5. Repeatability: At least two concentration levels of samples were repeatedly tested 10 times, and the variation coefficient CV ≤ 15%.
6. Batch-to-batch difference: Three batch reagent kits were used to test the same sample, and the batch-to-batch variation coefficient CV ≤ 15%.
7. Accuracy: 50 sera were tested, and the results were all within the expected range.
8. Specificity:
a) Interfering substances: Hemoglobin at 400 mg/L, triglycerides at 2000 mg/dL, bilirubin at 20 mg/dL, RF at 2000 IU/ml, ANA at 400 U/ml, and AMA at 400 U/ml have no effect on negative reference samples and detection limit reference samples.
b) IgA at 700 μg/ml, IgG at 7000 μg/ml, IgM at 500 μg/ml, and IgD at 100 μg/ml have no effect on the detection results of negative reference samples and detection limit reference samples.
c) Total IgE: Total IgE at 3000 IU/ml has no effect on the detection results of negative reference samples and detection limit reference samples.
9. HOOK effect: An antibody concentration of 100 IU/ml will not produce a HOOK effect.

General Description

In the past decade, the number of people with allergies has been increasing worldwide. Allergy usually refers to Type I hypersensitivity reactions (immediate allergic reactions), which typically cause symptoms within 30 minutes of exposure to the allergen. The most common symptoms include: fever (rhinitis), conjunctivitis, measles (urticaria), allergic asthma, and other dangerous allergic reactions (anaphylactic shock).
Allergens that cause Type I hypersensitivity reactions are mostly proteins from the natural environment, such as plant pollen, animal fur, food, dust mites, and insect venom.
A significant characteristic of Type I hypersensitivity reactions is the combination of allergens with specific immunoglobulin E (IgE). Therefore, the detection of IgE has become an important means of allergic diagnosis.
This kit is not recommended for health check-ups in the general population. A positive or negative test result only represents the detection result of the corresponding IgE antibodies and is not necessarily related to whether the patient has a disease. It should not be used as the sole criterion for evaluating the patient's condition. The condition must be comprehensively analyzed in combination with the patient's manifestations and other laboratory tests.