RapidHIT ID Validation and Ongoing Support

Bode’s Comprehensive Rapid DNA Support

Bode's Rapid DNA support program creates a complete solution for our clients from implementation, to database development and through on-going reachback support.  The program consists of:

  • RapidHIT ID Validation and Ongoing Support:  Bode provides validation services and ongoing quality checks of the client's instrument.
  • BodeHITS Access, Database Development and Data Sharing:  Access to program to develop a DNA database.  This program includes the ability to search against other in-state DNA databases.
  • Rapid DNA Reachback Support:  On-demand support from qualified forensic DNA analysts to review flagged Rapid DNA samples.

RapidHIT ID Validation and Ongoing Support

Bode provides support in the validation of a RapidHIT ID™ instrument that tests for accuracy, reproducibility and precision in compliance with recommendations from the FBI’s Quality Assurance Standards.  The validation will be performed to the same level of quality that would be required for an accredited crime laboratory to use. 
 

Phase I: Validation Plan and Preparation of Samples

Bode will deliver a validation plan to the client that outlines testing and documentation required for the validation of the RapidHIT ID for testing of single-source reference and crime scene samples.

Bode then will prepare and deliver most samples to be run as a part of the validation of the instrument to the client. Client will also provide 5 reference samples to be run as a part of the validation.  Bode recommends running approximately 20 samples per sample cartridge type.   

Phase II: Running Samples and Data Analysis

Client will run the samples in the RapidHIT ID instrument according to their established protocols.  The resultant data will be provided to Bode to review.  Bode will advise if additional testing is required upon analyzing the data.

Client is responsible for labor and materials associated with running samples.

Phase III: Validation Report

Bode will provide a written report detailing the results of the validation. The report can be used to document the successful performance of the instrument.

Ongoing Maintenance

Bode recommends performing a performance check (2 samples) each time a new primary cartridge is utilized by the Client to verify the performance of the instrument.  Bode recommends performing a quality control test (2 samples) each time a new sample cartridge lot number is utilized by the Client to verify the performance of the instrument.  Bode will provide the Clients with ongoing support to review performance checks and quality control testing.

Client shall run designated samples within the Rapid Instrument at that time, and a Bode forensic analyst will review the results and issue a written notice confirming the results of that test and recommending whether or not the new cartridge can be utilized for forensic samples.

Typical Performance Check Project Timeline

Below is the outline of a typical effort.  Timelines are subject to change due to factors including but not limited to status of instrument installation, timeline to run samples.

RapidHIT ID is a trademark of Thermo Fisher Scientific