【Human IgG 免疫分析套組】USCNLIFE貨號#CEA544Hu。ELISA Kit for Immunoglobulin G (IgG)－太鼎生物科技/太鼎食安科技

ELISA Kit for Immunoglobulin G (IgG)

Organism species	Homo sapiens (Human)
Product No.	CEA544Hu
Sample type	Serum, plasma and other biological fluids.
Format	96-well strip plate
Assay length	2.5 hours
Detection range	1.23-100ug/mL The standard curve concentrations used for the ELISA’s were 100ug/mL, 33.33ug/mL, 11.11ug/mL, 3.7ug/mL, 1.23ug/mL
Sensitivity	The minimum detectable dose of this kit is typically less than 0.48ug/mL.

Specificity

This assay has high sensitivity and excellent
specificity for detection of Immunoglobulin G (IgG).

No significant cross-reactivity or interference between Immunoglobulin G (IgG)
and analogues was observed.

Recovery

Matrices listed below were spiked with certain level
of recombinant Immunoglobulin G (IgG) and the recovery rates were calculated by
comparing the measured value to the expected amount of Immunoglobulin G (IgG)
in samples.

Matrix	Recovery range (%)	Average(%)
serum(n=5)	80-94	85
EDTA plasma(n=5)	84-92	88
heparin plasma(n=5)	80-95	86

Precision

Intra-assay Precision (Precision within an assay): 3
samples with low, middle and high level Immunoglobulin G (IgG) were tested 20
times on one plate, respectively.

Inter-assay Precision (Precision between assays): 3 samples with low, middle
and high level Immunoglobulin G (IgG) 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 Immunoglobulin G (IgG) 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)	79-99%	97-105%	80-91%	78-97%
EDTA plasma(n=5)	79-97%	90-104%	87-96%	81-99%
heparin plasma(n=5)	85-102%	82-96%	78-92%	85-98%

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
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 50µL standard or sample to each well.

And then add 50µL prepared Detection Reagent A
immediately.

Shake and mix. Incubate 1 hour at 37^oC;

3. Aspirate and wash 3 times;

4. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37^oC;

5. Aspirate and wash 5 times;

6. Add 90µL Substrate Solution. Incubate 15-25 minutes at 37^oC;

7. Add 50µL Stop Solution. Read at 450 nm immediately.

Test principle

This assay employs the competitive inhibition enzyme
immunoassay technique. An antibody specific for Immunoglobulin G (IgG) has been
pre-coated onto a microplate. A competitive inhibition reaction is launched
between Horseradish Peroxidase (HRP) labeled Immunoglobulin G (IgG) and
unlabeled Immunoglobulin G (IgG) (Standards or samples) with the pre-coated
antibody specific for Immunoglobulin G (IgG). After incubation the unbound
conjugate is washed off. The amount of bound HRP conjugate is reverse
proportional to the concentration of Immunoglobulin G (IgG) in the sample.
After addition of the substrate solution, the intensity of color developed is
reverse proportional to the concentration of Immunoglobulin G (IgG) in the
sample.