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Rapid DNA Analysis

Rapid DNA or Rapid DNA Analysis

Q: What is Rapid DNA or Rapid DNA Analysis?

A: Rapid DNA, or Rapid DNA Analysis, describes the fully automated (hands free) process of developing a CODIS Core STR profile from a reference sample buccal swab. The “swab in – profile out” process consists of automated extraction, amplification, separation, detection and allele calling without human intervention.

As of June 2014, no Rapid DNA instruments have been approved by the FBI that meet this definition.

Q: What is the Rapid DNA Index System (RDIS)?

A: Rapid DNA Index System (RDIS) is the proposed fourth tier of NDIS; a fully integrated system capable of performing reference sample buccal swab STR analysis in 1-2 hours and initiating DNA enrollment and searches from a police booking station.

Q: How is the FBI involved in the development of Rapid DNA technology?

A: The FBI established a Rapid DNA Program Office in 2010 to direct the development and integration of Rapid DNA technology for use by law enforcement. The Program Office works with the Department of Defense, the Department of Homeland Security, the National Institute of Standards and Technology, the National Institute of Justice, and other federal agencies to ensure the coordinated development of this new technology among federal agencies. The Program Office also works with state and local law enforcement agencies and state bureaus of identification through the FBI’s Criminal Justice Information Services Division Advisory Policy Board to facilitate the effective and efficient integration of Rapid DNA in the police booking environment.

Q: What is the goal of the FBI’s initiative on Rapid DNA development?

A: The goal of the FBI’s Rapid DNA initiative is to develop commercial instruments capable of producing a CODIS-compatible DNA profile within two hours and to integrate those instruments effectively within the existing CODIS structure to search unsolved crimes while an arrestee is in police custody during the booking process. The FBI has been working on how to integrate this technology first into CODIS laboratory operations and then into police booking locations.

Q: Do these goals include the use of Rapid DNA technology on crime scene (forensic) samples?

A: At this time, these goals do not include the use of Rapid DNA technology on crime scene (forensic) samples because of the differences between forensic and known reference (offender/arrestee) samples. These differences may include the nature or type of sample, typical sample quantity and potential for reanalysis. A forensic sample may not be amenable to fully automated processing due to limitations in its quality and quantity.

Q: Is the Rapid DNA technology currently operational?

A: Several manufacturers have developed instruments for Rapid DNA analysis. These instruments are now being tested and evaluated by the FBI Laboratory and several other Federal agencies, such as the National Institute of Standards and Technology (NIST) and the Army Crime Laboratory. In January 2013, the manufacturers of the instruments attended a Scientific Working Group on DNA Analysis Methods (SWGDAM) meeting to discuss their instruments and obtain feedback on validation. Because developmental validation is a crucial first step in the commercial use of these instruments, SWGDAM, through its Rapid DNA Committee, has established a dialog with the manufacturers to assist them in their validation effort (see SWGDAM FAQs at http://swgdam.org/faq.html ). The FBI does not consider these Rapid DNA instruments for Rapid DNA Analysis operational until all applicable QAS validation standards are met and all necessary NDIS approvals are in place.

Q: Can a Rapid DNA instrument be used by an accredited forensic laboratory to develop DNA profiles from known reference samples?

A: If the following assumptions are met and a laboratory is in compliance with the FBI Director’s Quality Assurance Standards (QAS) enumerated below, a Rapid DNA instrument may be used to develop DNA profiles from known reference samples. As of March 2014, use of a Rapid DNA instrument by an accredited laboratory would be limited to Modified Rapid DNA Analysis defined below.

Assumptions:

1. A Rapid DNA instrument must be operated by an accredited forensic laboratory as required by the DNA Identification Act of 1994;

2. An accredited forensic laboratory must develop a DNA profile from a known reference sample; and

3. The Rapid DNA instrument must be used to conduct Modified Rapid DNA Analysis. Modified Rapid DNA Analysis describes the automated (hands free) process of developing a CODIS Core STR profile from a known reference sample. This process consists of integrated extraction, amplification, separation, and detection without human intervention, but requires human interpretation and technical review.

Use of a Rapid DNA instrument to conduct Modified Rapid DNA Analysis on known reference samples by an accredited laboratory requires compliance with the following:

  • Documentation of the developmental validation for the Rapid DNA instrument in accordance with the FBI Director’s QAS for DNA Databasing Laboratories (Standard 8.2);
  • Documentation of internal validation of the Rapid DNA instrument by the accredited laboratory in accordance with QAS standard 8.3;
  • Use of an NDIS approved DNA STR typing test kit (DNA typing kit with corresponding part number or catalogue number). A Modified Rapid DNA analysis incorporating an NDIS approved DNA typing kit is permitted as long as there is documentation that the chemistries and concentrations are exactly the same as the NDIS approved DNA STR typing kit (see the CODIS and NDIS Fact sheet for list of NDIS approved DNA STR typing kits)
  • Manual interpretation and review of the data by a qualified DNA analyst (as required by QAS Standards 9 and 12); or use of an NDIS approved Expert System in accordance with the NDIS Operational Procedures and QAS; and
  • Compliance with all QAS, including but not limited to, the use of controls.

If all of the above conditions are met, an NDIS participating laboratory is permitted to upload authorized known reference DNA records developed using a Modified Rapid DNA Analysis to CODIS.

In order for an accredited laboratory to perform Rapid DNA Analysis (unmodified) of known reference samples for upload to CODIS, both the DNA STR typing test kit and Expert System must be approved by NDIS in accordance with the NDIS Operational Procedures and QAS.

Q: Can a Rapid DNA instrument be used by an accredited forensic laboratory to develop DNA profiles from crime scene (forensic) samples?

A: No, the analysis of crime scene (forensic) samples by an Rapid DNA instrument would not be compliant with the FBI Director’s Quality Assurance Standards for Forensic DNA Testing Laboratories (Forensic QAS Standards 9.4 and 12.2). The FBI and SWGDAM are not currently considering or discussing the application of the QAS to the analysis of crime scene (forensic) samples by a Rapid DNA instrument. Forensic DNA records that are not compliant with the FBI’s QAS are not permitted to be searched in or uploaded to CODIS.

Q: When will law enforcement agencies be able to use Rapid DNA?

A: While the manufacturers are working on validation of these instruments, the FBI has been identifying and working on resolving issues that will need to be addressed to achieve the goal of using these Rapid DNA instruments in the booking environment. For example, the DNA Identification Act of 1994 (42 U.S.C. §14132) requires that the DNA records be generated by accredited laboratories in compliance with the FBI Director’s Quality Assurance Standards (QAS). Thus, legislation will be needed in order for DNA records that are generated by Rapid DNA instruments outside an accredited laboratory to be uploaded to the National DNA Index System (NDIS). Additionally, issues relating to the validation and certification of the Rapid DNA analysis instruments must be resolved before implementing this new technology as part of the booking process. The FBI recognizes that issues relating to NDIS approval/certification of the instruments and training of law enforcement personnel using the approved instruments must be resolved so that this new technology is used in a manner that maintains the quality and integrity of CODIS and NDIS.

Q: Is there an expected implementation date for the Rapid DNA technology?

A: As a consequence of these outstanding issues and the need for legislative changes, it is difficult to estimate when law enforcement agencies will be able to search profiles developed by a Rapid DNA instrument in CODIS. SWGDAM will continue its priority efforts for developing recommendations for revisions to the FBI Director’s QAS. The FBI will continue its collaboration with other Federal agencies in the testing and evaluation of the available Rapid DNA instruments as well as support for legislative changes necessary for implementation of this technology.

You may wish to check these FAQs periodically for progress updates on Rapid DNA as the FBI works to establish the proper foundation for the use of this technology through validation, guidelines, training, etc.