The Alpha-Fetoprotein (AFP) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of Afp.
Advantage
1.Certificate:ISO13485:2003, GMP
2.Sensitivity>9/10
3.Specificity>14/15
4.Precision: CV<15%
Intended Use
The Alpha-Fetoprotein (AFP) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of Alpha fetoproteinin human serum or plasma.
KIT COMPONENTS
Microplate 1 plate (96 wells). Coated with Goat anti-AFP antibody. Reference standard set 6 vials (0.5ml/vial). Contains 0, 20, 50, 100, 200, 300ng/ml AFP, lyophilized. 1U=1IU=1.21ng.Control 2 vials (0.5ml/vial). Contains 40, 150ng/ml AFP.Conjugate 1 vial (12ml). The solution contains HRP-labeled anti-AFP antibody, with Tris (6g/L) and stabilizing proteins, ready to use.Wash Buffer (25´) 1 vial (30ml). Diluted 25-fold in distilled water as described in section of Preparation of Reagent. Substrate Solution A 1 vial (6ml). Hydrogen peroxide-urea (approx. 0.6g/L) in citrate-acetate buffer solution (10 mmol/L).Substrate Solution B 1 vial (6ml). Tetramethyl benzidine dihydrochloride (10g/L).Stop Solution 1 vial (6ml). 2N sulphuric acid.Plate Covers 2 pieces
SPECIFIC PERFORMANCE CHARACTERISTICS
SensitivityThe minimum detectable concentration of AFP by this assay is estimated to be 10ng/ml. The sensitivity studies have been evaluated by using the national panel of purified Anti-AFP prepared by National Institute For the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection was not above 10mIU/ml.
SpecificityThe cross-reaction values of CEA(1000ng/ml), CA125(600U/ml) and CA19-9 (500U/ml) with this kit were less than 10ng/ml.
PrecisionThe inner analysis precision: CV%<15.0; the inter analysis precision: CV%<20.0