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In late November 2017, the Massachusetts Office of Chief Medical Examiner (MAOCME) issued their first official identification of a deceased person based on the accredited use of Rapid DNA in their lab. This represents the successful transition of Rapid DNA to a state agency as well as a successful modification and use of the AABB (formerly American Association of Blood Banks) Standards for accreditation of Rapid DNA for relationship testing.
MAOCME only just recently became accredited for relationship testing using Rapid DNA technology, developed by the Department of Homeland Security Science and Technology Directorate (S&T).
A single Rapid DNA machine replaces all of the typical DNA-based relationship testing equipment needed in the lab, explained Chris Miles, S&T’s Deputy Director of Standards Integration and Applications. MAOCME can also take the Rapid DNA system to emergency sites to identify disaster victims, if necessary. The new technology should significantly reduce the time it takes to help families find the remains of their loved ones.
“(Chris Miles) invested in our agency, which allowed us to achieve this important milestone. We are now able to identify human remains in-house and within a shorter time frame. Your (S&T’s) team of experts guided us through identifying and submitting the variances, obtaining samples and composing the validation documentation, creating procedures, reports and many other vital components to the overall process,” MAOCME Rapid DNA Laboratory Supervisor Kristine Cavicchi said.
MAOCME investigates sudden, violent and unexpected deaths, and identifies human remains. Before accreditation, MAOCME relied on a university laboratory to process DNA samples. The laboratory's results were accurate, but it took about eight months to get results back. MAOCME purchased the ANDE Rapid DNA technology in June 2015, from NetBio, one of S&T’s commercial partners.
AABB, the former American Association of Blood Banks, is the only standards and accrediting body for relationship testing. Miles worked with MAOCME to ensure they met all of relationship testing standards and were prepared for their on-site assessment, which AABB performed August 14, 2017. MAOCME was accredited for kinship testing using direct samples from persons and from bones of deceased individuals that matched the deceased person’s family members.
"You still need a family member or other DNA sample to compare to the collected sample, but once you have that, the results are available much faster than through a traditional lab," explained Dr. Henry Nields, former Massachusetts Chief Medical Examiner.
AABB standards for Rapid DNA technology, categorized by AABB as "closed systems," were written by a volunteer committee of expert ethicists, users, representatives from different areas of relationship testing, the Department of Defense, U.S. Citizenship and Immigration Services, and the State Department. Miles, part of S&T’s Capability Development Support Office of Standards, is on the AABB Relationship Testing Standards Committee.
"It's a real cross-section of people who are using it for immigration purposes," said Anne Chenoweth, Senior Director, Accreditation and Quality at AABB in Bethesda, Maryland.
"As new technology comes on board, like Rapid DNA, we watch how it is being used, and then roll it all into one area where standards can be written. We're always looking for what's coming up, down the road. We've been looking at Rapid DNA for a while," Chenoweth said.
AABB standards are updated every two years. The closed system standards will be included in edition 13 of AABB standards, scheduled for release January 2018.
DHS also needs an accredited laboratory to support Rapid DNA instruments used for anti-trafficking/smuggling efforts and other DNA uses. S&T is working with Customs and Border Protection Laboratories and Scientific Services to achieve that accreditation.
"Rapid DNA needs to show it has repeatable and accurate results that will stand up in court, if challenged," Miles said. "Hundreds of thousands of immigration DNA samples are processed through AABB-accredited labs each year to verify family relationships. Accreditation gives other DHS users confidence in using a new technology."
The Rapid DNA machine being loaded (S&T photo).
S&T Program Manager, Chris Miles, loads the Rapid DNA instrument (S&T photo).