About our test for lactose intolerance
With our lactose intolerance test a patient with symptoms can quickly receive answers about stomach problems which may or may not be due to primary lactase deficiency.
We offer different cooperative opportunities in which we tailor solutions for each customer. Our concept covers the entire chain from sampling kits and method of analysis to performing analysis and distribution of analytical results. Today, we sell our lactose intolerance test through pharmacies and they are also used by medical centres.
Simple sampling and secure results
Our lactose intolerance test is simple to perform. The CE-marked sampling kit contains sampling material, instructions and return packaging. A cheek scrape sample is taken by the patient at home and is then sent to our accredited (ISO/IEC 17025) and quality-assured laboratory for DNA analysis. The result of analysis, which is 99.5% certain, is obtained via our website with a personal code 5 days after the sample is received at our laboratory.
Background of our test
Lactose is a disaccharide which must be broken down into the simple sugars glucose and galactose before it can be absorbed in the body. The breakdown of lactose takes place in the small intestine by the enzyme Lactase phlorizin hydrolase (LPH), also called lactase.
For adults (primary) lactase deficiency is the lack of the enzyme lactase in an inherited genetic variation. Evolutionarily speaking, it has been advantageous to be able to break down lactose in populations where milk products were included in the diet and therefore mutations have arisen resulting in lactose tolerance. However there are still a number of individuals in these population groups who have the genetic variant associated with lactose intolerance. Two parents who are lactose intolerant can have children who are lactose intolerant.
The map below shows the percentage of individuals who do not have a shortage of the enzyme lactase and can therefore break down lactose in different parts of the world.
Figure: Interpolated map of the frequency of individuals who can break down lactose (lactose persistent, LP) in different parts of the world. The points on the map show where data is collected. The colour scale shows the calculated frequency of LP individuals (Itan et al. BMC Evol Biol. August 2010, 9 10:36
There are several mutations (single nucleotide polymorphism, SNP) described, which means the lactase gene is down-regulated. Inter alia studies in Finland identified an SNP at position 13910 (C>T) upstream of the lactase gene, which has been found to have a full association with lactose intolerance. This SNP is common in the European population but other population groups such as those in Africa and the Middle East with a significant proportion of lactose intolerance have not shown the same correlation between the genotype in position 13910 and lactose tolerance/intolerance. In these populations other mutations are reported which are associated with lactose intolerance.
However during the first years of childhood the genotype –13,910 C/C commonly exists without lactose intolerance. The age at which a lack of lactase enzyme occurs varies by individual but the problem of primary lactose intolerance usually comes first in adolescence.
If the patient has symptoms and the test indicates a genotype (C/C) which is associated with reduced production of lactase and therefore an intolerance to dairy products that contain lactose, patients can, if necessary and in consultation with a nutritionist, adjust their diet and get rid of their problems. The ability to break down lactose varies in individuals with lactose intolerance, some can tolerate small amounts of lactose while others do not tolerate any at all. If the test indicates a genotype (C/T or TT) which is associated with normal production of lactase and therefore a tolerance of dairy products that contain lactose, lactose intolerance is excluded and the patient can seek further investigation via medical care to receive diagnosis and treatment .
Unique and safe method of analysis
The Dynamic Code test for lactose intolerance is based on the method published by Ridefelt et al (2005), which utilizes the position -13910 (C>T) to analyse lactose intolerance. The genotype CC is associated with lactase deficiency, while genotype CT and TT are associated with a normal ability to break down lactose. Dynamic Code uses PCR to detect the SNP positions C and/or T. For validation see below under Quality and Security. The study by Ridefeldt et al. measures the genotype of 51 people who also carried a lactose load with measurement of blood glucose. The results showed a strong correlation between the DNA method and lactose load in 94% of subjects. Other studies with 58 and 166 patients respectively, compare genetic testing of position 13910 with lactose load from breath tests showing that the specificity of the DNA test is between 91 and 95% and sensitivity is between 86 and 100% compared to the load test (Krawzcyk et al. 2008, Büning et al. 2005).
Information and price quotes
For more information about our lactose intolerance test and for potential collaboration, contact us.
Phone: +46(0)13 465 53 20
Quality and security
- A comparison of Dynamic Code method and Sanger sequencing (47 samples) showed 100% agreement in the results.
- Analyses are performed at the Dynamic Code laboratory, accredited under ISO/IEC 17025 and reviewed by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).
- For external ongoing quality control Dynamic Code participates in external quality research in laboratory medicine in Sweden’s (EQUALIS) quality program DNA analysis, DNA Lactase gene.
- Sampling kits are CE marked according to IVD Directive 98/79/EC as well as the MDD directive 93/42/EEC and in addition to future legislative changes.
- Studies have shown that the method used is secure and instructions for the lactose intolerance test are clear and safe when it comes to taking the sample correctly, sending the sample and obtaining the results. Overall, this creates certainty of 99.5%.
- The Lactose intolerance test is registered with the Swedish Food and Drug Administration.
Almon R, Engfeldt P, Tysk C, Sjöström M, Nilsson TK. Prevalence and trends in adult-type hypolactasia in different age cohorts in Central Sweden diagnosed by genotyping for the adult-type hypolactasia-linked LCT -13910C > T mutation. Scand J Gastroenterol. 2007 Feb;42(2):165-70.
Büning C, Genschel J, Jurga J, Fiedler T, Voderholzer W, Fiedler EM, Worm M, Weltrich R, Lochs H, Schmidt H, Ockenga J. Introducing genetic testing for adult-type hypolactasia. Digestion. 2005;71(4):245-50.
Enattah NS, Sahi T, Savilahti E, Terwilliger JD, Peltonen L, Järvelä I. Identification of a variant associated with adult-type hypolactasia. Nat Genet. 2002 Feb;30(2):233-7.
Itan Y, Jones BL, Ingram CJ, Swallow DM, Thomas MG. A worldwide correlation of lactase persistence phenotype and genotypes. BMC Evol Biol. 2010 Feb 9;10:36.
Krawczyk M, Wolska M, Schwartz S, Gruenhage F, Terjung B, Portincasa P, Sauerbruch T, Lammert F. Concordance of genetic and breath tests for lactose intolerance in a tertiary referral centre. J Gastrointestin Liver Dis. 2008 Jun;17(2):135-9.
Kuokkanen M, Enattah NS, Oksanen A, Savilahti E, Orpana A, Järvelä I. Transcriptional regulation of the lactase-phlorizin hydrolase gene by polymorphisms associated with adult-type hypolactasia. Gut. 2003 May;52(5):647-52.
Mulcare CA, Weale ME, Jones AL, Connell B, Zeitlyn D, Tarekegn A, Swallow DM, Bradman N, Thomas MG. The T allele of a single-nucleotide polymorphism 13.9 kb upstream of the lactase gene (LCT) (C-13.9kbT) does not predict or cause the lactase-persistence phenotype in Africans. Am J Hum Genet. 2004 Jun;74(6):1102-10
Nagy D, Bogácsi-Szabó E, Várkonyi A, Csányi B, Czibula A, Bede O, Tari B, Raskó I. Prevalence of adult-type hypolactasia as diagnosed with genetic and lactose hydrogen breath tests in Hungarians. Eur J Clin Nutr. 2009 Jul;63(7):909-12.
Ridefelt P, Håkansson LD. Lactose intolerance: lactose tolerance test versus genotyping. Scand J Gastroenterol. 2005 Jul;40(7):822-6.