Rapid DNA Analysis
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.
Q: What is Modified Rapid DNA Analysis?
A: 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.
Q: Are there additional quality assurance requirements for the use of Rapid DNA instruments/systems?
A: Based upon recommendations from the Scientific Working Group on DNA Analysis Methods (SWGDAM), the FBI Director approved and issued The Addendum to the Quality Assurance Standards for DNA Databasing Laboratories performing Rapid DNA Analysis and Modified Rapid DNA Analysis Using a Rapid DNA Instrument (or “Rapid QAS Addendum”). The Addendum contains the quality assurance standards specific to the use of a Rapid DNA instrument by an accredited laboratory; it took effect December 1, 2014.
Q: Are DNA profiles generated from a Rapid DNA instrument performing Modified Rapid DNA Analysis eligible for the National DNA Index System (NDIS)?
A: An accredited laboratory participating in NDIS may use CODIS to upload authorized known reference DNA profiles developed with a Rapid DNA instrument performing Modified Rapid DNA Analysis to NDIS if the following requirements are satisfied:
- The NDIS participating laboratory is complying with the FBI’s Quality Assurance Standards for DNA Databasing Laboratories (or “Databasing QAS”) and the Rapid QAS Addendum, including, but not limited to, the use of controls and quarterly recertification/performance checks;
- The NDIS participating laboratory has documentation of the developmental validation for the Rapid DNA instrument in accordance with Databasing QAS 8.2;
- The NDIS participating laboratory has documentation of its internal validation of the Rapid DNA instrument in accordance with Databasing QAS 8.3;
- The Rapid DNA instrument is using an NDIS-approved PCR STR typing test kit (DNA typing kit with corresponding part number or catalogue number) and the NDIS participating laboratory has documentation that the chemistries and concentrations are exactly the same as the NDIS-approved PCR STR typing kit; and
- The NDIS participating laboratory is performing manual interpretation and review of the data by a qualified DNA analyst as required by Databasing QAS 9 and 12.
If using an NDIS-approved PCR STR typing test kit with the same chemistries and concentrations and all of the above criteria have been satisfied by the NDIS participating laboratory, the Rapid DNA instrument does not require NDIS approval to be used to perform Modified Rapid DNA Analysis.
A: Yes, DNA records generated by an NDIS-approved Rapid DNA system performing Rapid DNA analysis in an NDIS participating laboratory are eligible for NDIS. A Rapid DNA system is defined as the combination of a Rapid DNA instrument with the corresponding PCR STR typing kit and Expert System. NDIS participating laboratories seeking approval of a Rapid DNA system should contact the NDIS Custodian early in the validation process to discuss the approval criteria and process. For example, developmental validation shall be conducted on all Rapid DNA systems where either the Rapid DNA instrument, PCR STR typing kit, and/or Expert System was not previously approved for use at NDIS. A Rapid DNA instrument using an NDIS-approved PCR STR typing test kit with the same chemistries and concentrations to perform Modified Rapid DNA Analysis and satisfying the criteria described in the above question does not require NDIS approval.
Once a Rapid DNA system has been approved for use at NDIS, there shall be no changes or modifications to the following: (1) Rapid DNA instrument; (2) the chemistries and/or concentrations of the PCR STR typing kit; or (3) the settings of the Expert System. An NDIS participating laboratory seeking to change any corresponding component of an NDIS-approved Rapid DNA system shall submit such request to the NDIS Custodian for approval before implementation in the NDIS-approved Rapid DNA system.
Additionally, NDIS participating laboratories using an NDIS-approved Rapid DNA system shall maintain documentation of the following for audit and accreditation purposes:
- Compliance with the FBI’s Databasing QAS and the Rapid QAS Addendum, including, but not limited to, the use of controls and quarterly recertification/performance checks;
- Developmental validation for the Rapid DNA system in accordance with Databasing QAS 8.2; and
- Internal validation of the Rapid DNA system in accordance with Databasing QAS 8.3, except that an NDIS participating laboratory using an NDIS-approved Rapid DNA system (as listed in this section) is not required to perform a separate internal validation of the Expert System being used by the NDIS-approved Rapid DNA system.
A: Yes. Effective March 16, 2016, the following Rapid DNA system has been approved for use by an accredited forensic laboratory for performing Rapid DNA Analysis:
- DNAscan Rapid DNA Analysis System with the following components:
|Component||Part/Version Number||GE Part Number|
|DNAscan System Software||1.3.55||Not Applicable|
|DNAscan Expert System Software||1.0.6||Not Applicable|
Q: Can a Rapid DNA instrument/system be used by an accredited forensic laboratory to develop DNA profiles from known reference samples for upload to CODIS and NDIS?
A: An NDIS participating laboratory using either a Rapid DNA instrument to perform Modified Rapid DNA analysis or an NDIS-approved Rapid DNA system to perform Rapid DNA analysis, in accordance with the respective requirements, may upload authorized known reference DNA records to CODIS and NDIS.
Q: Can a Rapid DNA instrument/system be used by an accredited forensic laboratory to develop DNA profiles from crime scene (forensic) samples for upload to CODIS and NDIS?
A: No, the analysis of crime scene (forensic) samples by a Rapid DNA instrument/system 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) and is not covered by the Rapid DNA Addendum. The FBI continues to monitor the development of Rapid DNA technology to address the range of crime scene samples. Forensic DNA records that are not compliant with the FBI’s QAS are not permitted to be searched in or uploaded to CODIS.
Rapid DNA Program
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 facilitate 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 (CJIS) 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 link commercial instruments capable of producing a CODIS-compatible DNA profile within 2 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 is working to integrate this technology into CODIS laboratory operations, then into police booking locations.
Q: Do these goals include the use of Rapid DNA technology on crime scene (forensic) samples?
A: The FBI continues to monitor the development of Rapid DNA technology to address the range of crime scene samples. 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 have been and continue to be tested and evaluated by the FBI Laboratory and 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 SWGDAM meeting to discuss their products 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://www.swgdam.org/faq.html). As of March 2016, at least one accredited laboratory is using a Rapid DNA instrument to perform Modified Rapid DNA analysis on known reference samples. Additionally, one Rapid DNA system has been approved for use at NDIS.
Q: When will law enforcement agencies be able to use Rapid DNA?
A: While the manufacturers are working on validation of Rapid DNA instruments/systems, the FBI has been identifying and working on resolving issues that will need to be addressed to achieve the goal of using Rapid DNA systems 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 systems outside an accredited laboratory to be uploaded to NDIS.
Within one to two years following passage of the necessary federal legislation, the FBI intends to develop and implement the necessary interfaces for booking stations to access CODIS. During this time, the FBI hopes to implement pilot projects within major metropolitan police departments to test and evaluate the use of Rapid DNA systems and the searching of DNA records through CODIS during the booking process. The FBI Laboratory has been working with the CJIS Division and the CJIS Advisory Policy Board (CJIS APB) Rapid DNA Task Force since 2010 to plan the effective integration of Rapid DNA into booking stations following a change in federal law.
The FBI recognizes that NDIS approval/certification of the systems and training of law enforcement personnel using the NDIS-approved systems must also 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 use of Rapid DNA technology in booking environments by law enforcement agencies?
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 system in CODIS and NDIS. The FBI will continue its collaboration with other law enforcement agencies in the testing and evaluation of the available Rapid DNA systems as well as support for legislative changes necessary for implementation of this technology.