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FGF23 (C-terminal) ELISA

multi-matrix ELISA for serum and plasma samples. - Standardized quantification in pmol/l. - CE marked - for IVD use in EU.

PRODUCT DETAILS

Assay characteristics:

Cat.No.: BI-20702
Method: Sandwich ELISA, HRP/TMB, 12x8-well strips
Sample type:Serum, plasma (EDTA, heparin, citrate)
Standard range:0-20 pmol/l (7 serum based standards)
Standard points:0/0.2/0.6/1.8/5/10/20 pmol/l
Control:2 serum based controls
Sample size:50 µl / well
Incubation time:20-24 h / 1 h / 30 min
Unit conversion:1 pg/ml = 0.133 pmol/l (MW: 7.52 kDa)

Sensitivity:
LOD: 0.08 pmol/l (0 pmol/l + 3 SD); LLOQ: 0.1 pmol/l

Precision:
Intra-assay: 2 samples of known concentrations were tested 6 times within 1 kit lot by 1 operator.
Inter-assay: 2 samples of known concentrations were tested 10 times within 2 different kit lots by 4 different operators.

Intra-assay (n=6) Sample 1 Sample 2
Mean (pmol/l) 0.6 10.0
SD (pmol/l) 0.07 0.06
CV (%) 12 6
Inter-assay (n=10) Sample 1 Sample 2
Mean (pmol/l) 0.6 9.9
SD (pmol/l) 0.06 0.50
CV (%) 10 5

Spike/Recovery:
The recovery of FGF23 was evaluated by adding 2 concentrations of human recombinant C-terminal FGF23 (5 + 10 pmol/l) to different human sample matrices. 

Matrix Mean S/R [% ]
+5 pmol/l +10 pmol/l
Serum (n=13) 96 89
EDTA plasma (n=7) 97 94
Heparin plasma (n=8) 101 92
Citrate plasma (n=7) 100 90

Dilution linearity:
Dilution linearity was assessed by serially diluting samples containing endogenous FGF23 with assay buffer.

Matrix Mean R of dilution steps [%]
1+1 1+3 1+7
Serum (n=9) 105 100 108
EDTA plasma (n=4) 103 103 106
Heparin plasma (n=10) 107 106 104
Citrate plasma (n=5) 102 106 101

Specificity:
The assay measures both intact FGF23 and C-terminal FGF23. The assay recognizes endogenous (natural) and recombinant human FGF23.

Calibration:
This immunoassay is calibrated against recombinant human FGF23 (C-terminal) peptide.

Values from apparently healthy individuals:
Median serum (n=35): 0.8 pmol/l
Median EDTA plasma (n=22): 1.3 pmol/l
Median heparin plasma (n=22): 1.2 pmol/l
Median citrate plasma (n=30): 1.4 pmol/l
It is recommended to establish the normal range for each laboratory.

Principle of the assay: 



Manual ELISAs - easily adaptable for automation! 

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INSTRUCTIONS FOR USE

Click link for:

BI-20702 FGF23 ELISA IFU

Biomedica Analytical Service Quotation Form

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VALIDATION DATA

Click here for assay validation data (S/R, dilution linearity, precision, ...).

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ADDITIONAL INFORMATION

FGF23 (fibroblast growth factor 23) is a 32-kDa protein with 251 amino acids that is proteolytically processed between arginine179 and serine180 to generate N-terminal and C-terminal fragments. FGF23 is mainly secreted by osteocytes and controls phosphate and 1,25(OH)2 vitamin D homeostasis.

Click here for MSDS 
Click here for PRODUCT LEAFLET 
Click here for CORRELATION DATA between different FGF23 assays

Click here for PRESS RELEASE

Klicken Sie hier für den FGF23 ELISA Flyer in deutscher Sprache. 

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REFERENCES, APPLICATIONS

FGF23 metabolism, a new paradigm for chronic kidney disease.
Piec I. et al, ASBMR2015 poster, SA0001

Click here for Reference List.

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