Biomedica Immunoassays

525 €

Contact us!

FGF23 (C-terminal) ELISA

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

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!