Prealbumin KAI-053 (K-ASSAY)
For In Vitro Diagnostic Use
Kit composition
| Reagent 1 (R-1) Buffer Reagent | 4 × 20 ml |
| Reagent 2 (R-2) Antiserum Reagent | 2 × 8 ml |
Precision
The precision for the K-ASSAY Prealbumin assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I | Sample II | Sample III |
|---|---|---|
| N = 20 Mean = 11.2 SD = 0.145 CV = 1.29% |
N = 20 Mean = 24.9 SD = 0.289 CV = 1.16% |
N = 20 Mean = 57.0 SD = 0.767 CV = 1.35% |
Correlation
A comparison of the K-ASSAY Prealbumin assay and a similar Prealbumin assay was performed on a Hitachi 717. The test results provided the following data.
| Y | = 0.9164x + -0.332 |
| r | = 0.9924 |
| n | = 50 |
| X | = Similar Prealbumin assay |
| Y | = K-ASSAY Prealbumin assay |
| X | min | = | 5.7 |
| max | = | 43.2 | |
| mean | = | 22.89 | |
| Y | min | = | 4.2 |
| max | = | 38.4 | |
| mean | = | 20.64 |
Interference
| Bilirubin F and C | No interference up to 22 mg/dl |
| Hemoglobin | No interference up to 470 mg/dl |
| Lipemia | No interference up to 5% |
