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Principle of the method
Purified anti-human Cystatin C antibody which was coated inpolystyrene particles when mixed with samples containing Cys C,  form insoluble complexes. This complex results in turbidity which will expand with coated polystyrene particles, the turbidity is proportional to the Cys C concentration in the sample. A-muti-level calibration curve is used to determine the rheumatoid factor.
Reagent composition
DiluentR1 PBS buffer *0 mmol/L,  PEG ***0,Surfactant.
AntibodyR2):PBS buffer *0 mmol/L, anti-human Cys C sensitized emulsion,Preservative.
Storage and Shelf Life
1.Sored tightly closed at **8ºC.
2. Non-open kit stored tightly closed at **8ºC has *2 month shelf  life, once opening, the kit has one more month at**8ºC storage
Applied analyzer
Spectrophotometer or biochemical analyzer with **0nm wavelength.
Sample
Fresh serum or plasma. Do not use highly hemolized or lipemic samples.If not determine in time, store at**0. Avoid repeat freezing and melting.
Procedure
 

  1. Assay methodtwo pointwavelength**0nm
  2. Application on chemistry analyzer:
Sample Reagent(R1/R2 Temperature Reaction timeT1/T2
3μL **0μL/*0μL *7 **0s/**0s
 
 
Unit Reaction Direction Standard curve simulation formula
mg/L Positive Multi point calibration, non-linearity calibration mode
3. Determination:Add3uLsamples into**0μL R1,mix thoroughly and incubate the cuvette at *7℃ for **0 seconds. Mix*0μL R2and read the absorbance A1against the blank. thoroughly and incubate the cuvette for **0 seconds, read the absorbance A2. The absorbance of complex isAA*-A1.
Note: different chemistry analyzer has own specifications, but should be subject to the basic specifications herein above, and the kit could be used after setting on the chemistry analyzer.
Reference values
Below or equal 1.*3mg/L. Each laboratory should establish its own reference range.
Interferences
No interference up to:
Hemoglobin       ***0mg/dl
Bilirubin          *0mg/dl
Triglycerides      ***0mg/dl
RF              **0IU/ml
Performance characteristics
1. Accuracy:relative deviation below ±*5% by reference material
2.Precision: CV≤8% within batch,CV≤*0% between batch
3. Assay a range: 0.5mg/L8.0mg/L
 

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Mr. linda < Immunotech International, LLC (GIMT) >

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