E0710 (CTK RECOMBILISA HBsAG, 96)

The RecombiLISA HBsAg ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the antibody sandwich technique.  The two main kit components are:
A 96-well breakable microplate pre-coated with monoclonal anti-HBs antibody;
A liquid conjugate composed of polyclonal HBsAb conjugated with horseradish peroxidase (HRP-HBsAb conjugate)
This test is intended for the qualitative detection of hepatitis B surface antigen (HBsAg) at a sensitivity level of 0.10 IU/mL in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of an infection with HBV.  Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.
HBsAg detection can be used to diagnose both acute and chronic HBV infection, and in combination with other HBV markers such as core and envelope proteins and antibodies, can aid in accurate diagnosis of disease state as well as post-vaccination immunity. HBsAg detection is highly recommended for all blood donors, pregnant women, and people in high-risk group.
HBsAg, as one of the first antigen markers, may be detected as early as 1–2 weeks after exposure and is persistent for the duration of clinical symptoms. Long term presence (> 6 months) of HBsAg is a marker of chronic HBV infection, and is the primary risk factor for development of chronic liver disease and cancer.
 
Analytical sensitivity against WHO 3rd International Standard (12/226): 0.10 IU/mL
Sensitivity: 100% (95% CI: 97.34% – 100%)
Specificity: 100% (95% CI: 98.73% – 100%)
Intra Assay Precision: CV 23% (negative), 9% (weak positive),7% (medium positive)
Inter Assay Precision: CV 25% (negative), 10% (weak positive),7% (medium positive)
Cross Reactivity: No false positive results were observed on 3-10 positive specimens of dengue, HAV, HCV, HIV, pylori, syphilis, ANA, HAMA, RF (up to 8400 IU/mL), respectively.
Interference: No interference was seen with bilirubin (6.7-20 mg/dL), EDTA (1.1-3.4 µM), salicylic acid (1.3-3.8%), creatinine (147-442 µM), heparin (1000-3000 U/L), glucose (18-55 mmol/L)
Shelf life: 15 months
Open vial stability:  8 weeks  at 2-8°C, or until the expiration date