Intended Use
The Human Anti-IgA isotype IgG ELISA is a sandwich enzyme immunoassay for the quantitative measurement of human anti-IgA antibodies in the IgG class.
Feature
1. For research use only!
2. The total assay time is less than 3 hours
3. The kit measures IgG anti-IgA antibodies in serum and plasma (EDTA, citrate, heparin)
4. Assay format is 96 wells
5. Calibrator is human serum based
6. Quality Controls are human serum based. No animal sera are used
7. Components of the kit are provided ready to use, concentrated or lyophilized
Contents of Kit
Conjugate Solution, ready to use, 13 ml
Master Calibrator, ready to use, 1.4 ml
Quality Control POSITIVE, ready to use, 0.7 ml
Quality Control NEGATIVE, ready to use, 0.7 ml
Inhibitory Control POSITIVE, lyophilized, 1 vial
Inhibitory Control NEGATIVE, lyophilized, 1 vial
Dilution Buffer, ready to use, 100 ml
Wash Solution Conc. (10x), concentrated, 100 ml
Substrate Solution, ready to use, 13 ml
Stop Solution, ready to use, 13 ml
Storage
Store the complete kit at 2-8°C. Under these conditions, the kit is stable until the expiration date (see label on the box).
Performance Characteristics
For research use only!
The total assay time is less than 3 hours.
The kit measures IgG anti-IgA antibodies in serum and plasma (EDTA, citrate, heparin).
Assay format is 96 wells.
Calibrator is serum based.
Quality Controls are human serum based. No animal sera are used.
Components of the kit are provided ready to use, concentrated or lyophilized.
Detection Range
1.56-100 U/ml
Detection Limit
0.71 U/ml
Sensitivity
Limit of Detection (LOD) (defined as concentration of analyte giving absorbance higher than mean absorbance of blank plus three standard deviations of the absorbance of blank: Ablank + 3×SDblank) is calculated from the real IgG anti-IgA antibody values in wells and is 0.71 U/ml.
Note: Dilution Buffer is pipetted into blank wells.
General Description
Anaphylactoid reaction induced by IgG anti-IgA antibodies may occur in individuals with IgA deficiency. The incidence of IgA deficiency is quite common in the population, with its frequency reaching nearly 1:400. Formation of immunocomplexes of antibodies (IgG anti-IgA) with antigen (IgA) leads to complement activation. Anaphylactoid reaction that release vasoactive anaphylatoxins (C3a, C4a, C5a) is a serious complication in transfusions or immunoglobuline replacement therapy. Like anaphylactic reaction, it is accompanied by hives, hypotension, dispnoea with bronchospasm or stridor.
Anti-IgA antibodies are found in patients with undetectable IgA levels. In about 10% of patients with IgA deficiency (IgAD) and with common variable immunodeficiency (CVID), anti-IgA antibodies are present. A causal relationship has been between IgG anti-IgA antibodies and the development of anaphylactoid reactions has been demonstrated, especially for cases when antiIgA antibodies are in higher concentrations.
Patients with IgA deficiency who need a blood transfusion or blood derivatives substitution should receive negative IgA blood components or an autotransfusion should be performed. Measurement of anti-IgA antibodies should be carried out in patients requiring this treatment.
The recommendation for subjects with known anaphylactoid reaction is to perform the test for anti-IgA at the interval of at least ten days after the response (the onset of antibodies production). Alternative subcutaneous immunoglobulin replacement therapy (SCIG) may be considered if anaphylactoid reactions to intravenous gammaglobulin therapy (IVIG) have occured and if antiIgA antibodies are present.
Citations
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