Dynamic Code quality policy

- an extract and summary

The analyses in the Dynamic Code laboratory are accredited and reviewed by the Swedish Board for Accreditation and Conformity Assessment (Styrelsen för ackreditering och teknisk kontroll, SWEDAC) according to ISO/IEC 17025.

For ongoing external quality assurance, Dynamic Code participates in several international quality tests and comparisons with several laboratories participating.

The sampling package is CE-labeled according to In Vitro Diagnostic Directive (IVDD) 98/79/EC and in part under Medical Device Directive (MDD) 93/42/EEC, as well as related amendments to the law.

The test is registered with the Swedish Medical Products Agency (Läkemedelsverket) and consequently is included in the EUDAMED database. The routines pertaining to the chlamydia test have been verified with the Swedish National Board of Health and Welfare (Sosialstyrelsen).

The instructions for taking the sample correctly, submitting the sample and retrieving the result are safe. They have been tested and adapted in studies with ordinary people. The methodological accuracy of these health tests is minimum 99.5%, see below. We do not state a total accuracy for predisposition for being overweight, etc.

Dynamic Code has routines for the way the Swedish chlamydia test is linked to Infectious Disease Control Act requirements related to chlamydia testing. These have been verified by the Swedish National Board of Health and Welfare. We also report all positive chlamydia cases to the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) through SmiNet.

Dynamic Code developed its own method for detection of chlamydia trachomatis, which is based on polymerase chain reaction (PCR). A validation study of 414 samples, where the Dynamic Code method was compared to the Chlamydia trachomatis PCR kit from Qiagen, showed a result of 99.7% specificity and 100% sensitivity.

Dynamic Codes developed its own method for detection of Mycoplasma (Mycoplasma genitalis) which is based on polymerase chain reaction (PCR). A validation study of 200 samples (19 positive and 181 negative) where the Dynamic Code method was compared to a method from an externa laboratory it showed a 100% conformity.

Dynamic Code developed its own method for analysis of muscle classification, which is based on PCR. A validation study of 53 samples compared the Dynamic Code PCR method to Sanger sequencing at an external laboratory. It showed 100% conformity.

Dynamic Code developed its own method for analysis of the predisposition for being overweight, which is based on PCR. A comparison of the Dynamic Code method and Sanger sequencing at an external laboratory of a total of 61 samples for the FTO gene, 60 samples for the PPARG gene, 58 samples for the APOA5 gene and 58 samples for the FABP2 gene showed 100% conformity.

Dynamic Code developed its own method for analysis of lactose intolerance, which is based on PCR. The method detects SNP positions C and/or T 13910 (C>T) upstream from the gene for the lactase-phlorizin hydrolase (LPH) enzyme. The C>T change at -13910 has proven to be associated with lactose intolerance. Genotype CC causes the phenotype lactose intolerance, while CT and TT cause lactose tolerance. The method has been validated by comparing the genotype to the result from Sanger sequencing. Sanger sequencing was performed at an external laboratory on 47 samples and showed 100% conformity.