There are two principle accreditation agencies, CLIA and AABB, that are most often referred to when determining the regulation of all DNA testing laboratories.
Clinical Laboratory Improvement Amendments (CLIA)
Passed in 1988 by the United States Congress to establish quality standards for laboratories working with human samples and providing medical diagnostic results, CLIA is regulated by the Centers for Medicare & Medicaid Services (CMS). CLIA standards were established “to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.” For a laboratory to earn CLIA accreditation, it must undergo proficiency testing on all of its techniques and daily procedures for testing human samples and reporting results.
American Association of Blood Banks (AABB)
The second accreditation that is often mentioned is from the AABB. The goal of the AABB accreditation program is to “promote the highest standards of medical, technical, and administrative performance, scientific investigation, clinical application, standard setting, accreditation, and education.” As one of its customized assessments, AABB conducts an accreditation program that evaluates and accredits family relationship and parentage testing for DNA testing laboratories, under which category Journey Genetic’s affiliates are listed.
All CLIA and AABB accredited laboratories must pass a rigorous review and inspection of their testing processes and laboratory to insure that tests are being done accurately and thoroughly. Accredited laboratories also participate in proficiency tests and are re-inspected annually.
How accreditation affects paternity/relationship testing
To be an accredited paternity test or accredited family relationship test (sibling, grandparent, or avuncular), the AABB requires that the DNA samples that are being collected to be tested must be:
a) witnessed by a neutral third party with no interest in the outcome of the test;
b) photographic proof of identity is required to be submitted with the test to verify the identity of the persons submitting the samples;
c) each test is run twice for all exclusions to insure accuracy.
Home DNA test accreditation
Many families choose instead to perform a private home DNA test because it is more affordable, or they may want to perform the test without one or more of those whose DNA is being examined knowing about the test. Home DNA testing cannot be AABB accredited.
Any DNA home test, from any testing lab, that does not require proof of identity, does not follows a strict chain-of-custody, the direct collection of a DNA sample from each person being tested, and the use of a neutral witness, is not considered an AABB accredited test.
Legal DNA test accreditation
Our Legal (aka Court Admissible) DNA Test Kits follow all accredited testing standards and come with full instructions on the responsibilities of the witness, as well as and what qualifies as proof of identity.
The only difference between our private home tests and our direct collected legal DNA tests is the manner in which the sample is collected and sent to our lab. The processing of your sample is identical, the finding report issued is the same, and each test follows all CLIA and AABB guidelines once it arrives at the lab.
Although AABB accreditation is strongly recommended, it is not required by any legal Federal or State law or statute for submission of paternity and family relationship DNA test results to a legal entity or government agency. Acceptance of evidence in any legal situation is always at the discretion of the court.