This kit is intended to be performed on the Neptune Instrument.
The test is based on the principle of an Enzyme Immunoassay.
The test strip is composed of a membrane fixed on a specific plastic support.
During the automated test procedure, the Neptune instrument sequentially incubates the strips in the wells of ready-to-use reagent cartridges.
Briefly: the strips are first incubated with diluted patients’ sera. Human antibodies, if present, bind to the corresponding specific antigen(s) dotted on the membrane.
Unbound or excess antibodies are removed by washing.
Upon further incubation into AP-conjugated goat antibodies against human IgG, the enzyme conjugate binds to the antigen-antibody complexes.
After removal of excess conjugate by washing, the strips are finally incubated into a substrate solution.
Enzyme activity, if present, leads to the development of purple dots on the membrane pads.
The intensity of the coloration is directly proportional to the amount of antibody present in the sample.
All the measured results are fully quantitative thanks to a 6 point built-in calibration curve, including blank control.
Different types of controls (sample, conjugate and substrate) are also coated on the strips.
Their presence validates the whole process of the test (from sample loading to substrate kinetics, through conjugate specificity / reactivity).
For optimum precision, all dots are coated in a triplicate microdot format, allowing calculation of a mean value and a confidence interval for each parameter (antigens, calibration curve and controls).