Assay development

Diagnostic Laboratory

All quantitative PCR assays performed in our analytical laboratory have been developed and validated by the Scanelis Research and Development department.

Our specifications are very strict:

• the test must be adapted to the field needs (quantitative aspect, vaccine strain typing, pathogen strain detection).

• the analytical specificity of the test is assessed on reference strains and field strains. Sequencing is performed to check it during the validation stages.

• the limit of detection which assesses the sensitivity of the test is determined by statistical studies (Probit analyses) according to the European pharmacopoeia recommendations. A 95 % detection limit is thus calculated. Appropriate positive controls are then used for each analytical series to check this limit of detection for each analysis.

• the rate of asymptomatic carriers and the level of carriage (bacterial or viral load) are also assessed on different field populations to determine the clinical usefulness of the test (diagnostic specificity), in particular as compared with other diagnosis methods.

Support to industry

Scanelis also develops custom-designed assays, respecting these specifications and according to customers’ needs (clinical trials, quality control for the chemist industry, etc.).
Scanelis is able to assess the performance of a particular test developed by a customer (for limit of detection, specificity, reproducibility, etc).