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RIDASCREEN® Diphtheria IgG

Product Code. K3821

Intended use:

For in vitro diagnostic use. The RIDASCREEN® Diphtheria IgG test is an enzyme immunoassay (EIA) for the quantitative determination of IgG antibodies against Diphtheria toxoid in human serum. The test should be carried out to clarify the immune status.

 General information:

The symptoms of diphtheria are caused by Corynebacterium diphtheriae. The pathogenic behavior of C. diphtheriae is caused by a 62 kd exotoxin, the gene for which is located on a prophage. Diphtheria is a rare disease owing to the consistent vaccination of infants. But recent outbreaks in Eastern Europe show that the risk of infection is still present. An immune protection acquired in childhood did not last for life. Therefore, regular vaccination as well as information about the immune status is especially important for adults.
Vaccination is carried out using a toxoid obtained by treating the toxin with formaldehyde. This toxoid has the same antigenic properties as the toxin. Both vaccine titers and immunoglobulins present after recovery from an infection can be found in a toxoid-based EIA. Comparability of the measured values is ensured by matching to international units. Nevertheless, it has to be considered for EIA result validation that both the extent of the immune reaction after an vaccination and the period of vaccine protection may vary from patient to patient.

Test principle
Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second incubation step by using enzyme-labelled anti-human antibodies (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.

Specifications:

Format: Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)
Incubation time: 3 x 30 min at 37 ºC
Sensitivity: 98.3%
Specificity: 80.0%

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