Method: Latex Immunoturbidimetric Liquid reagents, R1:R2=3:1
CLINICAL SIGNIFICANCE
Breast cancer is the most common cancer in women and the main cause of cancer-related mortality. CA15-3 is the most widely used serum marker of breast cancer. But CA15-3 lacks specificity in the early diagnosis of breast cancer, so it can not be used in the early diagnosis of breast cancer. However, CA15-3 can provide accurate evaluation for the prognosis of those patients with breast cancer, so as to obtain more appropriate treatment. CA15-3 is convenient and accurate for the follow-up examination of breast cancer, which provides an effective means for timely detection of breast cancer recurrence or metastasis.
SENSITIVITY
When the sample concentration is 50U/mL, the absorbance change should ≥ 0.1000.
LINEARITY
The linearity is [5, 300] U/mL.
PRECISION
a)Repeatability
Use high/low concentration samples to test for 10 times, the coefficient of variation (CV%) of the measured value should be less than 10%.
b)Intermediate precision
The relative range (R) of three batches of kits randomly selected should not be more than 10%.
INTERFERENCES
Bilirubin
|
up to 40 mg/dL
|
Hemoglobin
|
up to 150 mg/dL
|
RF
|
up to 500IU//mL
|
TG
|
up to 1500mg/dL
|