제품상세

• Specificity

  This assay has high sensitivity and excellent specificity for detection of Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A).
  No significant cross-reactivity or interference between Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) and analogues was observed.

  Recovery

  Matrices listed below were spiked with certain level of recombinant Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) and the recovery rates were calculated by comparing the measured value to the expected amount of Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) in samples.

  Matrix	Recovery range (%)	Average(%)
  serum(n=5)	97-105	101
  EDTA plasma(n=5)	78-92	86
  heparin plasma(n=5)	78-94	82

  Precision

  Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) were tested 20 times on one plate, respectively.
  Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) were tested on 3 different plates, 8 replicates in each plate.
  CV(%) = SD/meanX100
  Intra-Assay: CV<10%
  Inter-Assay: CV<12%
  

  Linearity

  The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Fc Fragment Of IgG Low Affinity IIIa Receptor (FcgR3A) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.

  Sample	1:2	1:4	1:8	1:16
  serum(n=5)	93-101%	89-97%	79-89%	94-104%
  EDTA plasma(n=5)	78-101%	96-103%	94-104%	81-92%
  heparin plasma(n=5)	86-103%	80-96%	98-105%	84-95%

  Stability

  The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition.
  To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.

  Reagents and materials provided

  Reagents	Quantity	Reagents	Quantity
  Pre-coated, ready to use 96-well strip plate	1	Plate sealer for 96 wells	4
  Standard	2	Standard Diluent	1×20mL
  Detection Reagent A	1×120µL	Assay Diluent A	1×12mL
  Detection Reagent B	1×120µL	Assay Diluent B	1×12mL
  TMB Substrate	1×9mL	Stop Solution	1×6mL
  Wash Buffer (30 × concentrate)	1×20mL	Instruction manual	1

  Assay procedure summary

  1. Prepare all reagents, samples and standards;
  2. Add 100µL standard or sample to each well. Incubate 1 hours at 37°C;
  3. Aspirate and add 100µL prepared Detection Reagent A. Incubate 1 hour at 37°C;
  4. Aspirate and wash 3 times;
  5. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37°C;
  6. Aspirate and wash 5 times;
  7. Add 90µL Substrate Solution. Incubate 10-20 minutes at 37°C;
  8. Add 50µL Stop Solution. Read at 450nm immediately.