HBsAg Vaccine Activity ELISA Kit

Name: HBsAg Vaccine Activity ELISA Kit
SKU: DEIA-NS2502-5
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Vaccines formulated in Aluminum hydroxide or Alumgel

Detection Method

direct-ELISA

Intended Use

The HBsAg Vaccine Activity ELISA Kit is a commercial test to measure the active component of the vaccine (HBsAg) in vaccines formulated in Aluminum hydroxide or Alum gel. It is a simple, rapid, and sensitive test and required no extraction or harsh dissociation of the antigens from the gel (Alum).

Contents of Kit

No.	Components	Size	Storage Conditions
1	HBsAg Std. A-F	0.65 ml×6	2-8°C
2	Sample Diluent	15 ml×1	2-8°C
3	Anti-HBsAg-HRP Conjugate(50X)	0.15 ml×1	2-8°C
4	Sample/Antibody Conjugate Diluent(20X)	10 ml×1	2-8°C
5	Low NSB Diluent	15 ml×1	2-8°C
6	Wash buffer (100X)	10 ml×1	2-8°C
7	HRP substrate solution	12 ml×1	2-8°C
8	Stop solution	12 ml×1	2-8°C
9	ELISA Strip Plate	12 ml×1	2-8°C
10	Assay Tubes	50
11	Qtips	50

Storage

The kit contents, if unopened, are stable at 2-8°C until the expiration date printed on the label. The whole kit stability is at least 6 months from the date of shipping under appropriate storage conditions.

Detection Limit

Based on replicate determinations of the zero standard, the minimum HBsAg vaccine concentration detectable using this assay is ~12.00 ng/ml. The detection limit is defined as the value deviating by 2 SD from the zero standard.

General Description

A vaccine is a biological preparation that improves immunity to a particular disease. Some vaccines also contain chemicals called adjuvants to help stimulate the production of immunity against the vaccine active ingredients, making the vaccine more effective. Currently, the only adjuvants approved for human vaccine are aluminum containing compounds, including aluminum hydroxide or Alhydrogel®, aluminum phosphate, and potassium aluminum sulfate or alum. Aluminium adjuvants have been used in tetanus, diphtheria, pertussis, polio, rabies, and hepatitis A and B vaccines.
To ensure vaccine quality, regulatory authorities require the manufacturer to measure vaccine content in the final product. World Health Organization (WHO) recommends that at least 80% of the vaccine be adsorbed to the gel. In particular, it is essential to determine the amount as well as the identity and integrity of the antigens bound to aluminum containing adjuvants following formulation. Aluminum-based gels are typically fibrous or beaded in suspension. The presence of aggregates, turbidity, flocculent gels or beads in solution prevents direct quantitation of protein content in formulations using protein assays such as Lowry, BCA, or Bradford protein assay, not to mention that these assays are all non-specific and low in sensitivity. Alhydrogel formulations also do not allow complete dissolution or extraction making it very difficult to know the identity of the vaccines or know the amount of the protein after their dispensing. There have been several incidents of mislabeling of anti-fertility vaccine with tetanus vaccines. Therefore, there is an urgent need for a test not only to identify but measure the vaccine contents.

Standard Curve

NOTE: These data are for demonstration purpose only. A complete standard curve must be run in every assay to determine sample values. Each laboratory should determine their own normal reference values.