CRP (2) – High-Sensitive KAI-060 (K-ASSAY)
For In Vitro Diagnostic Use
Kit composition
| Reagent 1 (R-1) Buffer Reagent | 1 × 30 ml |
| Reagent 2 (R-2) Antiserum Reagent | 1 × 20 ml |
Sensivity
When a saline blank is used as a sample, the absorbance change per minute is -0.0050 to 0.0050, while a standard CRP solution containing 1000 micrograms/dl is 0.0650 to 0.1000 after subtracting the saline blank.
Specificity
When serum containing a known level of CRP (250 micrograms/dl) is measured, the assay value obtained is within 10%
Precision
Samples tested were commercial human CRP control serum.
Precision Assay: Within Run
| Sample I | Sample II | Sample III |
|---|---|---|
| N = 20 Mean = 2.37 SD = 0.112 CV = 4.73% |
N = 20 Mean = 8.26 SD = 0.226 CV = 2.73% |
N = 20 Mean = 16.91 SD = 0.267 CV = 1.58% |
Precision Assay: Between Runs
| Sample I | Sample II | Sample III |
|---|---|---|
| N = 10 Mean = 2.63 SD = 0.154 CV = 5.86% |
N = 10 Mean = 8.68 SD = 0.217 CV = 2.50% |
N = 10 Mean = 17.29 SD = 0.302 CV = 1.75% |
CRP values were tested on 3 days.
Assay Range
| Standard Protocol: | 10.0 to 2000 mg/dl or (0.1 to 20 mg/L) |
| High Sensitivity Protocol: | 5.0 to 1000 mg/dl or (0.05 to 10 mg/L) |
Lower Limit of Detection
| Standard Protocol: | 10 mg/dl |
| High Sensitivity Protocol: | 5 mg/dl |
Correlation
| Y | = 1.024X + 0.701 |
| r | = 0.998 |
| n | = 37 |
| X | = Company A's CRP (WHO) nephelometric assay |
| Y | = K-ASSAY CRP (2) |
Interference
| Bilirubin F and C | No interference up to 60 mg/dl |
| Hemoglobin | No interference up to 500 mg/dl |
| Lipid | No interference up to 1500 mg/dl triglycerides |
