Product Description
The BioDeviceLab Human Immunoglobulin A (IgA) ELISA Kit is a high-performance enzyme-linked immunosorbent assay developed for the quantitative determination of total human IgA in biological samples. IgA is the predominant immunoglobulin present in mucosal secretions and plays a critical role in immune defense at mucosal surfaces, including the gastrointestinal, respiratory, and genitourinary tracts.
Quantification of IgA is widely used in immunology, infectious disease, and mucosal immunity research, as well as in studies of immune deficiencies, inflammation, and host–pathogen interactions. This assay combines high analytical sensitivity, excellent specificity, and robust reproducibility, making it suitable for routine laboratory analysis and advanced biodevice validation workflows.
Intended Use
This kit is intended for the quantitative determination of human IgA in:
• Serum
• Plasma
• Saliva
• Cell culture supernatants
Applications include mucosal immunity research, infectious disease studies, vaccine and antibody response evaluation, organ-on-chip immune models, and biodevice calibration and benchmarking.
Assay Principle
This assay employs a sandwich ELISA format:
• Human IgA present in the sample binds to capture antibodies immobilized on a 96-well microplate.
• A biotinylated detection antibody specific to human IgA binds to the captured immunoglobulin.
• An enzyme conjugate is added, followed by chromogenic substrate (TMB).
• The enzymatic reaction generates a colorimetric signal measured at 450 nm.
• Absorbance is directly proportional to the IgA concentration in the sample.
Calibration Curve
• A calibration curve is generated using human IgA standards with known concentrations.
• Mean absorbance values are plotted against IgA concentration on a semi-logarithmic scale.
• A four-parameter logistic (4PL) regression model is recommended for curve fitting.
Analytical Performance
Dynamic detection range: 0.1 – 25 ng/mL
Limit of detection (LOD): ≤ 0.02 ng/mL
Intra-assay CV: < 6%
Inter-assay CV: < 15%
(Performance aligned with commercial human IgA ELISA kits used in immunology and serology research.)
Selectivity & Specificity
The assay demonstrates high specificity for human IgA with minimal cross-reactivity. Representative specificity profile:
• Human IgA: 100%
• Human IgG, IgM, IgE: < 1%
• Non-human immunoglobulins: minimal cross-reactivity
This specificity ensures accurate IgA quantification independent of other antibody isotypes.
Kit Components
Each kit contains sufficient reagents for up to 96 determinations:
• Antibody-coated 96-well microplate
• Human IgA standards
• Biotinylated detection antibody
• Enzyme conjugate
• Assay buffer
• Wash buffer (10×)
• TMB substrate
• Stop solution
• Detailed assay protocol
Required Materials (Not Provided)
• Microplate reader capable of measuring absorbance at 450 nm
• Adjustable micropipettes and disposable tips
• Plate washer or manual washing equipment
• Plate shaker (recommended)
• Deionized or distilled water
Sample Collection & Handling
• Collect samples using standard laboratory procedures.
• Avoid repeated freeze–thaw cycles.
• Samples exceeding the highest standard should be diluted using assay buffer.
• Hemolyzed or lipemic samples may affect assay accuracy.
Quality Control
• Standards and controls should be included in each assay run.
• Duplicate measurements are recommended.
• Acceptance criteria should be established according to experimental requirements.
BioDeviceLab applies quality-controlled reagent preparation and batch-to-batch consistency practices to support reproducibility and scalability for biodevice development.
Storage & Stability
• Store all components at 2–8 °C.
• Do not freeze reagents unless explicitly stated.
• Unopened kits are stable until the stated expiration date.
• Opened reagents should be handled according to protocol recommendations.
Limitations
• For research use only.
• Not intended for diagnostic or therapeutic procedures.
• Results should be interpreted within the context of experimental design and immune status.
Applications
• Mucosal immunity and antibody response studies
• Infectious disease and serology research
• Vaccine response evaluation
• Organ-on-chip and immune-on-chip models
• Biodevice calibration and benchmarking
