Hepatitis B Virus Surface Antigen (HBsAg) ELISA KIT

DAAN HBsAg ELISA is an enzyme-linked immunosorbent assay (for the qualitative determination of Hepatitis B Surface Antigen.

 

Advantage

 

1.Certificate:ISO13485:2003, GMP, sFDA approved 
2.Sensitivity: 0.5ng/ml

3.Precision: CV<15%

 

Intended Use

 

DAAN HBsAg ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of Hepatitis B Surface Antigen(HBsAg) in human serum or plasma.

 

KIT COMPONENTS

 

Microplate  1 plate (96 wells). 8 strips per plate, each with 12 wells coated with anti-HBs. Positive Control  1 vial (1.0ml). Inactivated Human serum containing HBsAg. Preservative: Bronidox (2ml/L).Negative Control  1 vial (1.0ml). Inactivated Human serum without HBsAg. Preservative: Bronidox (2ml/L).Conjugate  1 vial (6ml).  The solution contains HRP-labeled anti-HBs, with PBS(0.01mol/L) and stabilizing proteins, ready to use.5.        Sample Diluent  1 vial (3.5ml).  

Contains stabilizing proteins and detergent, Preservative: Bronidox (2ml/L).

Wash Buffer (25´)  1 vial (20ml).  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 piecesInstruction manual  1 copy

 

SPECIFIC PERFORMANCE CHARACTERISTICS

 

Sensitivity

The sensitivity studies have been evaluated by using the national panel of purified HBsAg prepared by National Institute For the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection was not above 0.5 ng/ml.

Specificity

The specificity has been determinated on blood donors’ samples (11083 samples tested) and on hospitalized patients (1580 samples tested). The specificity calculated is respectively 100% and 99.87%.

Precision

Assay reproducibility was determined by assaying 3 specimens in replicates of 10 on 2 consecutive runs using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the coefficient of variation (%CV) were calculated (Table I).

The mean signal to cut-off ratio (S/CO) is defined as the Mean Sample Absorbance divided by the calculated Cut-Off value.