How we measure SNPs

Collection of DNA samples

Our laboratories have been isolating DNA isolation with various platforms for more than a dozen years. We have tested and compared various methods of DNA sample collection and found that the buccal swab outperforms others — such as saliva collection — in terms of the amounts of DNA obtained and the reliability and reproducibility of the DNA sample. We quality control each DNA sample to ensure that sufficient volume and concentration of DNA has been achieved for genotype analysis.

Sample Genotyping

deCODE uses the Illumina’s Infinium® II whole-genome genotyping method to for measuring individuals’ genotypes for the test specific markers (single nucleotide polymorphism: SNP´s). The Illumina’s Infinium® II whole-genome genotyping method has been analytically validated at deCODE for sensitivity, specificity, accuracy, precision and robustness. Each SNP is also clinically and analytically validated independently, prior to use.

Proficiency testing

deCODE runs a Proficiecny Testing Program on quarterly basis for verification of laboratory testing performance. Proficiency testing samples are processed as if real customer samples and blinded to personnel. All instances of failures/non-conformance are investigated and handled according to a standard operational procedure for incident investigation.

Accreditations

deCODE participates in the College of American Pathologists (CAP) Laboratory Accreditation Program and has a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Accreditation. deCODE also holds current licensure or permits required by the following states: California, Maryland, Pennsylvania and Rhode Island.

Licensure / Accreditation Certificate	ID Number	Certification Mark
CAP	7202211
CLIA	99D1064986	–
ISO 13485:2003	MD 570389	–
California	COS00800221	–
Maryland	1568	–
Pennsylvania	031241	–
Rhode Island	LCO00597	–

This content was last reviewed on May 16, 2012.