Rapid DNA

General Information

Rapid DNA, or Rapid DNA analysis, is a term used to describe the fully automated (hands free) process of developing a DNA profile from a reference sample buccal (cheek) swab without human intervention. The goal of the FBI’s Rapid DNA initiative is to link FBI approved commercial instruments capable of producing a CODIS core loci DNA profile within two hours to the existing CODIS infrastructure in order to search unsolved crimes of special concern while a qualifying arrestee is in police custody during the booking process.

The FBI Laboratory Division has been working with the FBI Criminal Justice Information Services (CJIS) Division and the CJIS Advisory Policy Board (CJIS APB) Rapid DNA Task Force to plan the effective integration of Rapid DNA into the booking station process. To use Rapid DNA analysis effectively during the booking process, the Bureau is developing the necessary interfaces for such booking stations to communicate with CODIS. As part of these development efforts, the FBI will begin testing and evaluation of the Rapid DNA booking communications infrastructure and within select federal, state and local law enforcement for the uploading and searching of DNA records through CODIS during the booking process.

The use of the term “reference sample buccal (cheek) swab” is intentional. The FBI’s current development and validation efforts have been focused on the DNA samples obtained from known individuals, eg., persons under arrest. Because known reference samples are taken directly from the individual, they contain sufficient amounts of DNA, and there are no mixed DNA profiles that would require a scientist to interpret them. For purposes of uploading or searching CODIS, Rapid DNA systems are not authorized for use on crime scene samples. All crime scene samples must be processed by an accredited forensic DNA Laboratory that follows the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories to be eligible for upload and/or search in CODIS.

The Rapid DNA Act of 2017 (Public Law 115-50) was signed by the President on August 18, 2017. The Act authorizes the FBI Director to “issue standards and procedures for the use of Rapid DNA instruments and resulting DNA analyses.” Now that the law is in place, the Bureau will be working toward the testing and implementation of this new technology and is poised to deliver the capability to process a Rapid DNA upload and search in the CODIS software within the first half of 2018. The FBI anticipates testing of components to begin in 2019. Integration into the booking process of states that are authorized to collect DNA samples at arrest, as well as the federal system, will follow.

The FBI is currently working with the Scientific Working Group for DNA Analysis Methods (SWGDAM) and other stakeholders to develop standards and procedures for the FBI approval and operation of the Rapid DNA systems. The Bureau recognizes that National DNA Index System (NDIS) approval of the Rapid DNA systems and training of law enforcement personnel using the approved systems are integral to ensuring that Rapid DNA is used in a manner that maintains the quality and integrity of CODIS and NDIS.

Background on FBI Rapid DNA Efforts

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 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 booking environment.

Several instruments have been developed 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 Defense Forensic Science Center (formerly the Army Crime Laboratory). In January 2013, the manufacturers of the instruments attended a 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, established a dialog with the manufacturers to assist them in their validation efforts (see SWGDAM FAQs.) While a Rapid DNA system was previously approved for use at NDIS with the 13 Original CODIS Core Loci, that system is no longer approved for use at NDIS due to the implementation of the 20 CODIS Core Loci effective January 1, 2017 (see NDIS Operational Procedures). Any Rapid DNA systems approved for use at NDIS will be posted on this website.

Prerequisites for Rapid DNA in the Booking Environment

IT enhancements, including Live Scan and criminal history information integration, are necessary for a booking station to input DNA profiles from Rapid DNA instruments into CODIS. In 2018, the FBI intends to deliver new CODIS software and other necessary CODIS interfaces for booking stations to communicate with CODIS. As part of these development efforts, the FBI will begin testing and evaluation of the Rapid DNA booking communications infrastructure and within select federal, state and local law enforcement for the uploading and searching of DNA records through CODIS during the booking process.

Below is a list of prerequisites for federal, state, and local booking agencies to participate in Rapid DNA:

  • The state must have implemented an Arrestee DNA collection law that authorizes DNA analysis at the time of arrest. Federal booking agencies already meet this prerequisite.
  • Electronic Fingerprint (Live Scan) integration during the booking process for obtaining State Identification Numbers (SID) (UCN for federal booking agencies) from the State Identification Bureau (FBI for federal) in near real time.
  • The booking agency must have network connectivity with the State Identification Bureau (SIB)/CJIS Systems Agency (CSA)

It will be critical for booking agencies to work with their State CODIS Administrator to ensure all requirements are met for participation in Rapid DNA (see Rapid DNA Requirements).

Crime Scene (Forensic) Samples Analyzed using Rapid DNA Systems are not Authorized for CODIS

For purposes of uploading and/or searching CODIS, Rapid DNA systems are not authorized for use on crime scene samples. The analysis of forensic samples by a Rapid DNA system is not compliant with the FBI Director’s Quality Assurance Standards (QAS) for Forensic DNA Testing Laboratories and therefore is not permitted to be uploaded and/or searched in CODIS. Cheek swabs are ideal for Rapid DNA machines, as they contain large amounts of fresh DNA from one individual. Forensic samples vary widely, from the age, exposure and nature of the sample to the amount and quality of DNA it may contain. Most critically, forensic samples often contain mixtures of DNA from more than one individual that requires interpretation by a trained scientist. For these reasons, all crime scene samples must be processed by an accredited forensic DNA Laboratory that follows the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories to be uploaded and/or searched in the CODIS system.

There are many challenges that must be overcome before the FBI can consider the use of Rapid DNA systems for crime scene sample analysis. The Bureau continues to assess how these challenges can be addressed to include monitoring enhancements to Rapid DNA technology. Among the major challenges is the requirement to determine the amount of DNA present in a sample (necessary to maximize the resulting quality of the DNA profile, assess for contamination, etc.) and the development of Expert Systems for crime scene sample analysis.

Implementation Status

Rapid DNA instrumentation will be implemented in two settings: (1) law enforcement booking station; and (2) accredited forensic DNA laboratory for reference sample analysis. Much of the preparation for using Rapid DNA in a laboratory setting has been completed and the FBI’s efforts are now focused on the standards and procedures for use of this technology in a law enforcement booking environment.

Booking Station and Laboratory Implementation Status

 

Law Enforcement Booking Station

Accredited Forensic DNA Laboratory

Type of Sample Eligible for Upload and Searching

Known reference buccal DNA sample

Known reference buccal DNA sample

Equipment

NDIS-approved Rapid DNA system

Validated Rapid DNA instrument or NDIS-approved Rapid DNA system

Personnel

Trained law enforcement personnel

Qualified analyst or trained laboratory personnel

Standards

In progress

FBI Director’s Quality Assurance Standards for DNA Databasing Laboratories Rapid DNA Addendum

Procedures

In progress

NDIS Operational Procedures

CODIS Communication Specifications

Rapid AEF and Rapid CMF

CODIS CMF


A Rapid DNA system is the combination of a Rapid DNA instrument with the NDIS-approved PCR STR typing kit (having the same chemistries and concentration) and onboard Expert system. A Rapid DNA system validation study must be submitted to the FBI by an NDIS participating laboratory for NDIS approval in order to upload DNA profiles generated from the Rapid DNA system to NDIS.

Currently there are no NDIS Approved Rapid DNA systems.

Please check this site for frequent updates on the status of the standards and procedures for Rapid DNA systems for use by law enforcement booking stations.

Accredited DNA Laboratory Use

DNA profiles generated by an NDIS-approved Rapid DNA system performing Rapid DNA analysis in an NDIS participating laboratory are eligible for upload and/or search in NDIS. Currently there are no Rapid DNA systems approved for accredited laboratory use. 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 must 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. Once NDIS-approved, the Rapid DNA system cannot have 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 must submit such request to the NDIS Custodian for approval before implementation in the NDIS- approved Rapid DNA system.

Accredited DNA laboratories have the ability to use approved Rapid DNA systems as well as Rapid DNA instruments that require DNA analyst interpretation. Rapid DNA analysis using a Rapid DNA system consists of automated extraction, amplification, separation, detection and allele calling without human intervention. The term “Modified Rapid DNA analysis” is used to describe when the Rapid DNA instrument is used and there is human interpretation and technical review of the resulting DNA analyses. An accredited forensic DNA laboratory has used a Rapid DNA instrument to perform Modified Rapid DNA analysis on known reference samples in accordance with the quality assurance requirements and the resulting DNA analyses have been uploaded to NDIS.

Additionally, an NDIS participating laboratory may upload authorized known or reference DNA profiles developed with a Rapid DNA instrument performing Modified Rapid DNA Analysis to NDIS if the QAS requirements described in the Table below are satisfied. If using an NDIS-approved PCR STR typing test kit with the same chemistries and concentrations and all of the requirements in Table below 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.

NDIS participating laboratories using a Rapid DNA instrument or system must be in compliance with the following quality assurance requirements: the FBI Director’s Quality Assurance Standards for DNA Databasing Laboratories and 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.

Currently there are no NDIS Approved Rapid DNA systems for accredited laboratory use. As systems are approved, notices will appear on this page.

Rapid and Modified Rapid DNA Analysis in an Accredited DNA Laboratory

 

Rapid DNA analysis

Modified Rapid DNA analysis

What it is

Automated extraction, amplification, separation, detection and interpretation with no human interpretation

Automated extraction, amplification, separation, detection with human interpretation and technical review of the resulting DNA analyses

Equipment

Rapid DNA system

Rapid DNA instrument

Approval by

FBI (referred to as NDIS-approved)

Formal approval not required if validated in accordance with the FBI Director’s Quality Assurance Standards

DNA Profiles Eligible for NDIS

Yes, for accredited forensic DNA laboratories using an NDIS-approved Rapid DNA system and documentation is maintained of the following: (No Rapid DNA system is currently approved for CODIS/NDIS

Yes, for accredited forensic DNA laboratories using Rapid DNA instruments as long as in compliance with the following:

 

✓ Compliance with the FBI’s QAS, including but not limited to, the use of controls and quarterly recertification/performance checks;

✓ Compliance with the FBI’s QAS, including but not limited to, the use of controls and quarterly recertification/performance checks;

 

 

Developmental and internal validation for the Rapid DNA system in accordance with the FBI’s QAS, except that an NDIS participating laboratory using an NDIS-approved Rapid DNA system is not required to perform a separate internal validation of the Expert System being used by the NDIS- approved Rapid DNA system.

✓ Documentation of the developmental and internal validations for the Rapid DNA instrument in accordance with FBI QAS;

✓ 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 there is documentation that the chemistries and concentrations are exactly the same as the NDIS-approved PCR STR typing kit; and

 

Yes, for booking stations in accordance with standards and procedures of the FBI Director (pending development).

✓ Performance of manual interpretation and review by a qualified DNA analyst as required by FBI QAS.