General Background
Because of the serious social and medico-legal consequences of misdiagnosing gonorrhoea great care must be taken in the identification of Neisseria gonorrhoeae.
Principle
GonoGen II employs a pool of murine monoclonal antibodies prepared against purified outer membrane protein (OMP or Protein 1) of Neisseria gonorrhoeae.
OMP is a major protein molecule that is exposed on the surface of the organism and its epitopes are largely responsible for serotype variation. The monoclonal antibodies are adsorbed onto suspended metal-sol particles, this forms the test reagent.
When the culture is emulsified in the solubilising buffer, the outer membrane of the organism is stripped off releasing the OMP containing complexes into solution. These released OMP complexes are then captured by the antibody/metal-sol particles.
The sample/reagent mixture is then filtered through the special matrix test device; the OMP-antibody/metal-sol complexes are held back by the matrix, resulting in a red spot. Antibody/metal-sol particles that have not bound OMP will pass through the matrix giving a negative result (white to pale pink ring).
Batch specific Cerificates of Analysis are available on request.
Material safety Data Sheet (En)
PHE, Standards for Microbiology Investigations: SMI ID 6: identification of Neisseria species
CDC: Identification of N. gonorrhoeae and Related Species
