Hepatitis B Surface Antigen Chemiluminescence Immunoassay Kit is a CLIA kit for the in-vitro quantitative determination of hepatitis B surface antigen (HBsAg) in human serum or plasma.
HBsAg, an outer membrane protein of Hepatitis B Virus (HBV), is one of the earliest markers that appear in the blood following infection with HBV. Infection with HBV results in the appearance of a number of serological markers and one of the first of such markers is Hepatitis B Surface Antigen (HBsAg). The HBV infection causes a wide variety of liver damages such as acute self-limiting infection, fulminating hepatitis, chronic hepatitis with progression to cirrhosis and liver failure, and a symptomatic chronic carrier state. HBsAg appears 1 - 7 weeks before biochemical evidence of liver disease or jaundice. Three weeks after the onset of acute hepatitis almost half of the patients will still be positive for HBsAg. HBsAg positive will disappear quickly in acute hepatitis. If HBsAg positive exist over 6 months, it will convert to chronic hepatitis or patient will become HBsAg carrier, and HBsAg positive will last several years or even longer. Therefore, screening for HBsAg is highly desirable for diagnostics and differentiation of Hepatitis B, research on epidemiology, follow-up visit, inspection on treatment efficacy, medicine selection and for all blood donors, pregnant women and people in high - risk groups.
The kit enables the in vitro determination of HBsAg level in human serum by the double – antibody sandwich assay principle. Two distinct monoclonal antibodies are employed to respectively bind two specific determinants: an anti-HBs monoclonal antibody is immobilized on the well to form solid phase and another monoclonal antibody is conjugated with enzyme. Upon mixing the immobilized antibody, the conjugate and a serum containing the native antigen, a solid antibody – antigen - conjugated antibody complex will form. After the bound fraction is separated from the unbound one by decantation or aspiration, the RLU measured is directly proportional to the concentration of HBsAg present in the unknown samples or the calibrators. The concentration of HBsAg in the unknown sample can be estimated from the reaction curve prepared by calibrators. For a better performance, the results could be read within 5 - 30 minutes after adding the substrate solution to ensure assay efficiency or precision.
The within-run variability shall be less than 15% (n = 10).
The between-run variability shall be less than 20% (n = 10).
The sensitivity is defined as being the smallest detectable concentration different from zero with a probability of 95%. The sensitivity of the assay shall be no more than 0.05 ng/mL.
Linearity concerned coefficient r shall be no less than 0.9900.
Six months at 2 – 8 °C.
Rapid Saliva Alcohol Test Strip is intended for use as a rapid method to detect the presence of alcohol in saliva for blood alcohol concentration (BAC) greater than 0.02%. It has been published that the concentration of alcohol in saliva is almost equal to that in blood.
The rapid test is intended for the semi-quantization of ethyl alcohol in human saliva. To confirm the concentration of positive specimens, an alternate, non-enzymatic technology such as headspace gas chromatography should be used.
Rapid Saliva Alcohol Test Strip is based on the high specify of alcohol oxidase for ethyl alcohol in the presence of peroxides and enzyme substrate such as tetramethylbenzidine (TMB).
The distinct color on reactive pad could be observed in less than 20 seconds after the tip was contacted with saliva samples with the ethyl alcohol concentration greater than 0.02%. It should be pointed out that other alcohols such as methyl, propane and ally alcohol would develop the similar color on the reactive pad. However, these Alcohols are not normally present in saliva.