Dynamic Code quality policy

- an extract and summary

The analyses of Dynamic Code's laboratory have been accredited in accordance with ISO/IEC 17025 and have been reviewed by the Swedish Board for Accreditation and Conformity Assessment (Styrelsen för ackreditering och teknisk kontroll, also known as SWEDAC). 

To maintain continuous external quality control, Dynamic Code participates in several international quality tests as well as myriad comparisons in which multiple laboratories participate. 

All sampling packages have been CE-marked in accordance with IVD Directive 98/79/EC and partially under MDD Directive 93/42/EEC along with subsequent amendments to the applicable legislation. 

The test has been registered with the Swedish Medical Products Agency (Läkemedelsverket) and has thus been recorded in the EUDAMED database. All procedures and routines related to the chlamydia test have been coordinated with the Swedish National Board of Health and Welfare (Socialstyrelsen). 

The instructions for the tests, such as instructions on how to correctly take samples, submitting the samples, and retrieving the test results, are safe procedures as they have been tested and adapted in studies conducted with laymen test subjects. The methodological safety of these health tests is very high; see below for more information. The security or accuracy of the tests has not been assessed for those who are overweight or may have other conditions.

Dynamic Code has procedures in place to ensure that all Swedish chlamydia tests adhere to the requirements listed in The Communicable Diseases Act (Smittskyddslagen) that relate to chlamydia testing. These procedures are further coordinated with the Swedish National Board of Health and Welfare (Socialstyrelsen). We also report all positive cases of chlamydia and gonorrhea to the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) via SmiNet. 

Dynamic Code utilizes a self-developed proprietary method for detecting chlamydia (Chlamydia trachomatis) based on PCR (polymerase chain reaction). A validation study testing of 414 samples with Dynamic Code’s PCR-kit testing methodology for Chlamydia trachomatis by Qiagen demonstrated a specificity of 99.7% and a sensitivity of 100%. 

Dynamic Code utilizes a self-developed proprietary method for detecting mycoplasma (Mycoplasma genitalis) based on PCR (polymerase chain reaction). A validation study of 200 samples (19 positive and 181 negative) was performed to compare the Dynamic Code testing methodology against that of an external laboratory. The results showed a 100% correspondence. 

 

Dynamic Code utilizes a self-developed proprietary method for detecting gonorrhoea (Neisseria gonorrhoeae) based on PCR (polymerase chain reaction). A validation study of 200 samples (73 positive and 127 negative) was performed to compare the Dynamic Code testing methodology against that of an external laboratory. The results showed a 99.5% correspondence. 

Dynamic Code utilizes a self-developed proprietary method for detecting trichomoniasis (Trichomonas vaginalis) based on PCR (polymerase chain reaction). A validation study of 144 samples (21 positive and 123 negative) was performed to compare the Dynamic Code testing methodology against that of an external laboratory. The results showed a 98.6% correspondence. 

Dynamic Code utilizes a self-developed proprietary method for muscle classification based on PCR (polymerase chain reaction). A validation study of 43 was performed to compare the Dynamic Code testing methodology against that of an external laboratory. The results showed a 100% correspondence. 
The gene being analysed in this test was determined in several scientific articles to have positive correlations with muscle capacity and physical performance. The gene is available in two variants; the variant an individual carries can provide especial insight into the properties of those muscles as well as the body's optimal conditions for exercise. Such information can help offer guidance on setting up a workout regimen in terms of training routines, intensity, and recovery periods based on these genetic conditions.

Dynamic Code utilizes a self-developed proprietary PCR-based method to assess predispositions for obesity.  A comparison study was performed comparing Dynamic Code's testing method with Sanger Sequencing in an external laboratory. The study tested 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. The results showed a 100% correspondence rate.
The four genes analysed in these tests were determined in several scientific articles have strong associations with the risk of becoming obese. The genes were also related to the effects of fat intake on BMI and whether an individual has a predisposition for higher levels of blood fats. Such information can help offer guidance on setting up a dieting regimen based on one of the many genetic conditions an individual may possess. Dynamic Code's method of analysis for lactose intolerance is a self-developed proprietary procedure. 

Dynamic Code uses a self-developed method to detect predispositions for primary lactose intolerance (lactase non-persistence, or LNP) based on PCR (polymerase chain reaction). This technique detects five different SNPs (single nucleotide polymorphisms) at positions -13907, -13910, -13915, -14009 and -14010 upstream of the gene responsible for producing Lactase phlorizin hydrolase (LPH). Possessing at least one polymorphism corresponding to C>G at -13907, C>T at -13910, T>G at -13915, T>G at -14009, or G>C at -14010 has been found to be associated with lactose tolerance (LP). A lack of these polymorphisms is typically associated with lactose intolerance. Dynamic Code's method of analysis has been validated by comparing the derived genotype with results obtained through Sanger Sequencing. The comparison was performed by an external laboratory on 97 samples. The results demonstrated a 100% correspondence rate. 

Dynamic Code utilizes a self-developed proprietary PCR-based method for detecting an increased risk of blood clots during estrogen intake. A validation study of 62 samples was performed to compare the Dynamic Code PCR-based testing methodology against the analysis of Sanger Sequencing by an external laboratory. The results showed a 100% correspondence. 

Dynamic Code uses a self-developed proprietary PCR-based method for testing bacterial and fungal infections of the genital regions. The technique detects and quantifies six of the most common bacteria present in bacterial vaginosis (Gardnerella vaginalis, Atophobium vaginae, Leptotrichia/Sneathia sp., Megasphaera sp., Mobiluncus sp., and BVAB2) in relation to the presence of Lactobacillus sp. It also tests for the presence of the fungus Candida sp. To check for bacterial vaginosis, the levels of the relevant bacteria in the sample are measured in relation to the level of Lactobacillus sp. present. A computational model determines the probability of bacterial vaginosis based on what is known as the “likelihood ratio” for each bacterium. If the sample demonstrates a likelihood ratio above 70% then it is defined as testing positive for bacterial vaginosis. The specificity of the technique was tested by analysing a panel of 24 bacterial and fungal species. The results showed that the PCR technique used was adequately specific and would not elicit “false positives” for closely related bacteria and fungi. In addition to cross-reactivity tests, bioinformatics in silico along with primer and probe sequences were compared to public databases. These comparisons also showed that the respective primer and probe designs were specific to the designated species. 

The reproducibility of the DNA test was tested and verified by analysing 23 randomly selected samples on three separate occasions; all of the tests showed complete agreement. Furthermore, a follow-up study was conducted together with the RFSU clinic in Stockholm. Based on a clinical examination and their medical history, women were diagnosed with bacterial vaginosis and/or Candida. The study included 205 women, 56 of whom were diagnosed with bacterial vaginosis, 31 of whom were diagnosed with Candida, and 2 of whom were diagnosed with both bacterial vaginosis and Candida. 116 were determined to be healthy women insofar as they were not diagnosed with either bacterial vaginosis and Candida. 

Dynamic Code uses a self-developed proprietary PCR-based method for testing for fungi of the nail, foot and skin. The technique detects and quantifies the most common species of the genera Trichophyton, Microsporum and Epidermophyton (e.g. T. rubrum, T. mentagophytes, T. verrrucosum, M. canis and E. floccosum). The specificity of the technique was tested by analysing a panel of 28 different fungal strains. The results showed that the PCR technique used was adequately specific and would not elicit “false positives” for closely related fungi. In addition to cross-reactivity tests, bioinformatics in silico along with primer and probe sequences were compared to public databases. These comparisons also showed that the respective primer and probe designs were specific to the designated species. The specificity studies demonstrated a methodological certainty of >99.5%.

Dynamic Code utilizes a self-developed proprietary method for detecting coeliac disease. The technique is partly based on PCR DNA technology and partly based on a method for investigating protein known as ELISA. A validation study has been carried out to ensure the quality and accuracy of the methodology. The DNA method showed a specificity of 87% with a sensitivity of 100%. The ELISA method was validated on a total of 191 samples and showed a combined specificity of 95% and a sensitivity of 95%. Dynamic Code’s testing procedures are all in accordance with the international guidelines set out by ESPGHAN (European Society for Paediatric Gastroenterology Hepatology and Nutrition).

Anne Kihlgren, CEO
Dynamic Code AB