VacciGel Diphtheria Toxoid ELISA Kit

Sample

Vaccine formulated in Alum

Species Reactivity

None

Intended Use

The VacciGel™ ELISA for Diphtheria Toxoid (DTX) is the first commercial test to measure the active component of DTX vaccines formulated in Adjuphos (Alum gel). It is a simple, rapid, and sensitive test and required no extraction or harsh dissociation of the antigens from the gel (Alum). This kit has been validated with Daptacel (DTAP, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbe, Sanofi). This kit can be used to measure DTX in monovalent of multivalent vaccines adsorbed on Alum (Trihibit (DTAP/Hib), ActHib (Hib-PRP-T), Trihibit (DTAP/Hib), Daptacel (DTAP), Tripedia (DTAP), Td (Adult), DecavacTM (tetanus/Diphtheria), Adacel (tetanus, Diphtheria, Acellular Pertussis), DT (Pediatric) - Sanofi Pasteur; Pediarix (DTAP/HepB/IPV), Infanrix (DTAP), Boostrix (Tetanus, Diphtheria, Acellular Pertussis)- GlaxoSmithKline).

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.

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.