The Importance of Having Your Genetic Variant Testing Carried Out by an ISO 17025:2017 Accredited Laboratory

Dr Koh Chong Lek, PhD (London), DIC, FASc

Chief Scientific Officer, Gene Express Sdn Bhd

The Gene Express Laboratory was accredited ISO/IEC 17025:2017 by the Department of Standards Malaysia on 17 September 2020 for the Illumina Infinium HTS Assay using DNA extracted from saliva or other biological sources (SAMM 980).

Why must you have your genetic or DNA variant testing carried out by an ISO/IEC 17025:2017 accredited laboratory?

The human haploid nuclear genome comprises approximately 3.2 billion pairs of deoxyribonucleotides (or popularly referred to as nucleotides or bases) of DNA, divided into 24 linear chromosomes. The four nucleotides of DNA are adenine, cytosine, guanine, and thymine (A, C, G, and T, respectively). The sequence or order of these four nucleotides within a DNA strand makes up the genetic code of a gene. Different genes (i.e., nucleotide or base sequences) encode the sequences of different RNA and polypeptide (protein) molecules.

In the simplest form, genetic variants (also known as mutations or variations) are nucleotide or base changes in DNA (e.g., A to C, G, or T change). If more than 1% of a population does not carry the same nucleotide at a specific position in a DNA sequence among individuals, then this variation is classified as a single nucleotide polymorphism (SNP). SNPs are the most common type of genetic variation among people. There are about 4 million to 5 million SNPs in a person’s genome. More than 335 million SNPs have been found across humans from multiple populations.

Genetic or DNA variant testing means determining the nucleotide or base changes in DNA. Different methods are used to accurately determine genetic variants in human genomes. In recent years, a number of high-throughput SNP genotyping methods have been developed to determine SNPs in DNA. One of the commonly used methods is the Illumina Infinium High-Throughput Screening (HTS) Assay which is capable of genotyping thousands of SNPs in a multi-sample BeadChip microarray.

The Illumina Infinium HTS Assay involves many precise steps: 1. Pre-amp: extract DNA, quantify DNA, amplify DNA; and 2. Post-amp: incubate DNA overnight (amplification), fragment DNA, precipitate DNA, resuspend DNA, hybridise fragmented DNA to BeadChip overnight, wash BeadChip, extend and stain BeadChip, and image BeadChip (scanning). It also involves a large number of precision instruments: for example, refrigerators, freezers, micropipettes, large centrifuges, microcentrifuges, ultrapure water system, spectrofluorometer, hybridization oven, incubators, hybridization chambers, BeadChips, water circulator with programmable temperature controls, chamber rack with temperature probe, staining racks, and iScan system.

Hence, it is important to have your genetic variant testing accurately carried by an ISO/IEC 17025:2017 accredited laboratory to determine the precise SNPs in your genome.

The laboratory must also have an excellent laboratory information management system (LIMS) to effectively manage samples, laboratory processes, test results, and associated data.

The internationally recognized ISO/IEC 17025:2017 accreditation ensures and confirms that a laboratory meets both the technical competence requirements for all the laboratory procedures and management system requirements necessary for it to consistently and competently deliver technically valid and reliable test results and calibrations. The test results generated from an ISO/IEC 17025:2017 accredited laboratory are confidently accepted globally without the need for further testing.

Every client of the ISO/IEC 17025:2017 accredited Gene Express Laboratory is assured of their valid and reliable genetic or DNA variant test results, which are accepted internationally.

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Disclaimer. TELEME blog posts contains general information about health conditions and treatments. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. The information is not advice and should not be treated as such. 

If you think you may be suffering from any medical condition, you should seek immediate medical attention from your doctor or other professional healthcare providers. You should never delay seeking medical advice, disregard medical advice, or discontinue medical treatment because of information on this website.

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