CRP (2) – High-Sensitive KAI-060 (K-ASSAY)

For In Vitro Diagnostic Use
CE

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