Human Anti-Hepatitis B Virus Core Antigen (HBc) Antibody ELISA Kit

Sample

Serum, plasma

Species Reactivity

Human

Detection Method

iELISA

Intended Use

This ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to hepatitis B virus core antigen (anti-HBc) in human serum or plasma.

Contents of Kit

1. PLATE, (1×96wells) 8×12/12×8-well per plate, MICROWELL PLATE: Blank microwell strips fixed on white strip holder. The plate is sealed in aluminum pouch with desiccant. Each well contains purified HBcAg. The microwell strips can be broken to be used separately. Place unused wells or strips in the provided plastic sealable storage bag together with the desiccant and return to 2-8°C. Once opened, stable for 4 weeks at 2-8°C
2. CONTROL-, (1×1ml per vial) preserv. 0.1% ProClin 300, NEGATIVE CONTROL: Yellowish liquid filled in a vial with green screw cap. Protein-stabilized buffer tested non reactive for anti-HBc. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
3. CONTROL+, (1×1ml per vial) preserv. 0.1% ProClin 300, POSITIVE CONTROL: Red-colored liquid filled in a vial with red screw cap. Purified anti-HBc diluted in protein-stabilized buffer. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
4. HRP-CON, (1×6.5ml per vial) preserv. 0.1% ProClin 300, HRP-CONJUGATE: Red-colored liquid in a white vial with red screw cap. Horseradish peroxidase-conjugated anti-HBc. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
5. WASH BUF 20×, (1×30ml per bottle), DILUTE BEFORE USE! detergent Tween-20 WASH BUFFER: Colorless liquid filled in a white bottle with white screw cap. Buffer solution containing surfactant. The concentrate must be diluted 1 to 20 with distilled/deionized water before use. Once diluted, stable for 1 week at room temperature, or for 2 weeks when stored at 2-8°C.
6. CHROM SOL A, (1×7ml per vial), CHROMOGEN SOLUTION A: Colorless liquid filled in a white vial with greenscrew cap. Urea peroxide solution. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
7. CHROM SOL B, (1×7ml per vial), CHROMOGEN SOLUTION B: Colorless liquid filled in a black vial with blackscrew cap. TMB (Tetramethyl benzidine), N,N- dimethylformamide. Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
8. STOP SOL, (1×7ml per vial), STOP SOLUTION: Colorless liquid in a white vial with white screw cap. Diluted sulfuric acid solution (0.5M H₂SO₄). Ready to use as supplied. Once opened, stable for 4 weeks at 2-8°C.
9. PLASTIC SEALABLE BAG: For enclosing the strips not in use 1 unit
10. PACKAGE INSERT 1 copy
11. CARDBOARD PLATE COVER 1 sheet
To cover the plates during incubation and prevent evaporation or contamination of the wells

Storage

The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of This anti-HBc ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.

General Description

Hepatitis B virus (HBV) is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces a spectrum of clinical manifestations ranging from mild, inapparent disease to fulminant hepatitis, severe chronic liver diseases, which in some cases can lead to cirrhosis and carcinoma of the liver. Classification of a hepatitis B infection requires the identification of a number of serological markers expressed during three phases (incubation, acute and convalescent) of the infection. Now several diagnostic tests are used for screening, clinical diagnosis and management of the disease. Hepatitis B "core" antigen (HBcAg) is a major component of the viral structure. HBcAg is composed of a single polypeptide of about 17 kD that is released upon disaggregation of the core particles; the antigen contains at least one immunologicaldeterminant. Antibodies to HBcAg (anti-HBc total antibody, and IgM) appear shortly after the appearance of HBsAg and persist for life both in persons who have recovered from a hepatitis B infection and in those who develop HBsAg-carrier status but in rare cases, a HBV infection can also run its course without the appearance of immunologically detectable anti-HBc (usually in immunosuppressed patients). Anti-HBc is a marker of acute, chronic or resolved HBV infection and screening for anti-HBc provides with information on the prevalence of the disease in different groups. In clinical diagnosis, the detection of anti-HBc is an important diagnostic marker and together with other hepatitis B test permits the diagnosis and management of the disease. In the absence of other hepatitis B markers (HBsAg-negative persons), anti-HBc may be the only indication of an existing hepatitis B viral infection.