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RH-with-Helix-on-GUIThe RapidHIT System is the first fully automated sample-to-profile system for STR-based human identification. Samples can be processed using our GlobalFiler® Express cartridges and uploaded to the Combined DNA Index System (CODIS).

RapidHIT human identification system produces standardized DNA profiles from buccal swabs and other crime scene samples in ~90 minutes. The RapidHIT System uses gold standard sample extraction, Polymerase Chain Reaction (PCR) and Capillary Electrophoresis (CE) technologies. Requiring only three minutes of hands-on time to generate one through seven DNA profiles, the easy to use system fits into any forensic workflow. The output from the system is compatible with local, state and national human identification databases.

  • Only Rapid DNA analysis system with NDIS approved chemistry
  • >93% full concordant profiles for 13 CODIS loci1
  • 100% concordance with NIST SRM 2391c standard1
  • Easy to use interface and software analysis
  • Room temperature storage of sample cartridges
  • Process any swab type or crime scene samples directly in the cartridge
  • Requires only ~3 minutes of hands-on time, less than 2 hours time to results

Grant Support for RapidHIT Systems

At IntegenX, we can provide key insights into grant proposals that will help laboratories receive the funding needed for forensic DNA systems. To assist forensic laboratories in meeting their technology needs, we have developed materials to help build a budget and cost justify projects. We understand the workflow with DNA and the costs associated with processing, analyzing and storing data.

Now use NIJ Funding for RapidHIT Systems

Effective December 1, 2014, the FBI approved Quality Assurance Standards for the use of a modified rapid DNA analysis system, such as the RapidHIT System, in forensics laboratories. After internal validation an accredited laboratory can now upload reference samples processed to the CODIS system.

With the establishment of the QAS, inquiries with the NIJ has confirmed that use of NIJ grant funds to acquire and operate the RapidHIT for reference samples is now possible. Check with your Program Manager to see if you can reallocate existing funding.

The goals of NIJ’s DNA Backlog Reduction Program is to assist eligible states and units of local government to:

  • Process, record, screen and analyze forensic DNA and/or DNA database samples.
  • Increase the capacity of public forensic DNA and DNA database laboratories to process more DNA samples, thereby helping to reduce the number of forensic DNA and DNA database samples awaiting analysis.

Source NIJ DNA Capacity Enhancement and Backlog Reduction Program

Why does RapidHIT Meet NIJ Goals

RapidHIT enables DNA sample processing and generation of a CODIS uploadable profile for reference samples as per QAS. This enables increased processing of samples and reallocation of resources thereby increasing capacity and efficiencies within the laboratory and reducing the overall backlog.

The RapidHIT platform requires less than 5 minutes of hands on time during set-up and offers walk away processing of DNA samples. The instrument generates 7 profiles within 2 hours and can be run using NDIS approved GlobalFiler Express chemistry with expert review prior to upload to CODIS. The instrument also incorporates the NDIS approved GeneMarker® HID analysis software from Softgenetics which enables direct upload to CODIS without the need for expert review following the definition of a Rapid DNA process. This allows for ‘Sample to Upload’ processing without the need for expert review thus enabling resources to be allocated to other sample processing. Use of RapidHIT would enable 28 CODIS profiles to be generated in a working day with less than 20 minutes of operator time. This would increase current and future laboratory capacity without taking time away from current resources and processes.

FAQ

Is there any other provider of Rapid DNA systems that meet QAS requirements?

NO – IntegenX is the only provider to meet the FBI requirements. RapidHIT can be run in either a modified Rapid DNA or Rapid DNA process mode. FBI Fact Sheet on Rapid DNA

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);

IntegenX has published development validation peer review paper which can be requested from IntegenX:

Developmental Validation of the GlobalFiler® Express Kit, a 24-marker STR Assay, on the RapidHIT® System
Lori K Hennessy, Neelima Mehendale, Kaiwan Chear, Stevan Jovanovich, Stephen Williams, Charles Park, Stefanie Gangano. Forensic Science International: Genetics, 13:247–258

This was performed per SWGDAM guidelines and can be used to support internal validation of the RapidHIT platform within your laboratory.

  • 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)

The RapidHIT cartridge contains unmodified NDIS approved GlobalFiler Express chemistry. There has been no change to the formulation as confirmed by Life Technologies (now part of ThermoFisher Scientific). A copy of this documentation is available upon request.

  • 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.

The instrument also uses NDIS approved GeneMarker® HID software from Softgenetics which enables direct upload to CODIS without the need for expert review following the definition of a Rapid DNA process.

Will use of RapidHIT affect my accreditation?

NO; QAS has released an audit document pertaining to Rapid DNA. This can be request from IntegenX or found here

FY 2014 NIJ Grant Guidelines stipulated in Budget Information section b) Expenses that are not permitted: Purchase of equipment for technologies that have not been approved for use by the National DNA Index System (NDIS), including personnel and supply costs that would be needed to validate equipment not approved for use by NDIS

Does this mean that RapidHIT is not eligible for funding?

RapidHIT is eligible for funding as confirmed by NIJ and FY2014 NIJ funding can be reallocated to fund RApidHIT instrument following submission of request and approval. This change is due to the QAS addendum released December 2014.

FY2015 NIJ Funding Application is now open, can I request funding to support purchase of RapidHIT

YES; FY’15 grants will support the purchase of the instrument, validation of RapidHIT equipment and cost of consumables to support reduction of backlog. The FY’15 funding guidelines categorize a sample that has not been processed / uploaded within 30 days of receipt as a backlog sample. Please contact IntegenX for support on grant submission.

 

GlobalFiler® Express KitINT_IMAGE_CARTRIDGES-APPROVED-SEAL

NDIS Approved GlobalFiler Express Chemistry for CODIS Upload

  • >90% full profile and CODIS success rate
  • Run 1 sample, 7 samples, or anything in between
  • Process any swab type or crime scene samples directly in the cartridge
  • Requires only ~3 minutes of hands-on time, less than 2 hours time to results

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RapidHIT® Helps Richland County Sheriff’s Department Make Arrest

Richland County Sheriff Leon Lott spoke about the investigation of a murder case solved in part with RapidHIT® System.
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Rapid DNA Device Yields First Evidence For Prosecution Of A Criminal Case

According to a press release on Feb 25, 2014, the Palm Bay Police Department, working closely with the State Attorney’s Office for the 18th Judicial Circuit, is ready to use DNA profiles obtained from the RapidHIT  in a criminal prosecution.
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First State-Wide deployment of the RapidHIT® System with SmallPond™ at Arizona Department of Public Safety

Arizona Department of Public Safety (AZ-DPS) Crime Lab Superintendent Vince Figarelli presents first state-wide deployment of the RapidHIT System for real-time matching using a SmallPond database of DNA profiles.
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The Arizona DPS Rapid DNA Program

In this presentation, Kathy Press, DNA Technical Leader of Arizona DPS, discussed the implementation of RapidHIT at the Arizona DPS.

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90 Minute DNA Profiles on a Fully Validated, Automated System

This presentation was presented on Nov 7, 2013, at the 7th International DNA Users’ Conference for Investigative Officers at Lyon, France (the INTERPOL Headquarters) by Dr. Joseph DiZinno, former Director of the FBI Laboratory.

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Effective December 1, 2014, the FBI has updated current DNA databasing standards for laboratories performing Rapid DNA analysis and Modified Rapid DNA Analysis Using a Rapid DNA Instrument.

The Addendum describes requirements that accredited labs must achieve in order for their results to be considered for inclusion in the Combined DNA Index System (CODIS).  The FBI has provided Auditing documents and Lab Checklists to ensure that these labs comply with the new Quality Assurance Standards.

Rapid DNA analysis generates DNA profiles in less than two hours.   This technology can be used by local and regional law enforcement, enabling them to eliminate irrelevant leads quickly – and bring the correct suspects to justice, before they can re-offend.  Delivering faster DNA profiles can aid in the reduction of violent crime by allowing law enforcement to focus their efforts on the right suspects more quickly.

IntegenX is the market leader in Rapid Human DNA identification with the RapidHIT System.