Total IgE KAI-092 (K-ASSAY)
For In Vitro Diagnostic Use
Kit composition
| Reagent 1 (R-1) Buffer Reagent | 2 × 20 ml |
| Reagent 2 (R-2) Antiserum Reagent | 1 × 6.6 ml |
Sensitivity
When a saline blank is used as a sample, the absorbance is below 0.05. When a calibrator containing 5 mg/dl of human albumin is assayed, the absorbance (after subtracting the absorbance value for the saline blank) is within the range of 0.131-0.525.
Specificity
When a urine sample with a known value is assayed, it is within 10% .
Precision
Precision Assay: Within Run
| Sample | I | II | III | IV | V |
|---|---|---|---|---|---|
| N Mean, IU/ml SD CV, % |
10 105.3 1.06 1.01 |
10 174.1 2.85 1.63 |
10 350.5 7.68 2.2 |
10 1117.8 13.26 1.2 |
10 1908.6 30.25 1.6 |
Precision Assay: Between Runs
| Sample | I | II | III | IV | V |
|---|---|---|---|---|---|
| N Mean, IU/ml SD CV, % |
10 105.4 2.72 2.58 |
10 177.6 3.24 1.82 |
10 663.7 11.22 1.69 |
10 2147.5 33.56 1.56 |
10 3304.7 16.67 0.50 |
Assay Range
10 - 2000 IU/ml (or value of highest calibrator)
Correlation
A comparison of the K-ASSAY Total IgE reagent and the Company X's Total IgE reagent was performed with the following results:
| Y | = 0.9851x + 10.618 |
| r | = 0.9928 |
| n | = 80 |
| X | = Company X's Total IgE |
| Y | = K-ASSAY IgE |
Interference
| Bilirubin F | No interference up to 18.5 mg/dl |
| Bilirubin C | No interference up to 21.6 mg/dl |
| Hemoglobin | No interference up to 467 mg/dl |
| RF | No interference up to 500 IU/ml |
| Sodium Citrate | No interference up to 15 mg/ml |
