Frequently Asked Questions about Rapid DNA and the RapidHIT System

General Questions

Q. What is the RapidHIT System?

A. The RapidHIT is a complete, fully automated Rapid DNA human identification system designed and developed by integrating IntegenX®’s proprietary and patented technologies with fast in-house microfluidic chip prototyping.

Q. How does it work?

A. Reagents in disposable cartridges are loaded on the system with up to eight buccal (cheek) swab samples. After a sample run is started, processing proceeds with no further user interation. The system extracts DNA from one to eight samples and performs STR amplifications, electrophoretic separations, and software analysis to generate full human identification profiles.

Q. What user skill level is required to operate the RapidHIT System?

A. IntegenX has adopted the US and UK military definition of “menu-driven user.” It is assumed that the user will have little science training and can follow the icon screen instructions. The typical user, such as a police officer or military service member, will not be required to have any special training in molecular biology or forensic laboratory procedures and can learn to operate the system successfully with approximately 30 minutes of training. Once the human identification data has been produced, it can be digitally transferred to a forensic DNA expert for final interpretation.

Performance Specifications

Q. How long does it take to run samples?

A. Run time is less than 90 minutes. Approximately 36 minutes for sample processing and STR amplification, 39 minutes for separations and detection, and four minutes for electrophoretogram analysis and reporting.

Q. How many samples can be processed at once?

A. The RapidHIT System processes from one to eight samples simultaneously in self-contained disposable cartridges.

Q. How many Rapid DNA human identification markers are analyzed?

A. In the US, the RapidHIT system uses the Promega PowerPlex 16HS Fast kit. In Europe, the system uses the either the PowerPlex 16HS Fast or the ESI 16 Fast kit.

Q. What sample types can be analyzed?

A. The RapidHIT System analyzes buccal swab reference samples. IntegenX has tested the RapidHIT system at five offsite locations, including a hotel room, beach, bunker, van, and tent. In these locations, the RapidHIT system has successfully produced full profiles from very diverse samples such as teeth, bottle necks, hat sweatbands, cigarette butts, clothing, and several touch swabs.

In summer 2011, trials with a respected US standards testing organization demonstrated full profile sensitivity from 125 pg to 5 µg. While IntegenX recommends that the system be used with a cotton swab, it has been tested successfully with various paper, polymer, polyester, and foam swabs, including FTA impregnated swabs.

Q. What is the reliability of the RapidHIT System by comparison to multiple-instrument forensic DNA analysis?

A. Testing by IntegenX as well as three outside organizations has found 100% concordance with “regular” DNA analysis. In an initial study completed in August 2010, analysis of 106 samples produced full STR profiles (15 alleles plus sex determination) in 103 samples, and full CODIS human identification profiles (13 alleles plus sex determination) in all 106 samples. Reliability has been shown to be as high as any widely used conventional sequencing system.

Q. What is the DNA base-pair resolution?

A. IntegenX has repeatedly demonstrated better-than single base resolution out to approximately 575 bases. System performance was tested and presented at the ISHI 2010 meeting in San Antonio, Texas, and at the 2010 Biometrics Consortium meeting in Tampa, Florida.

Physical Specifications

Q. What are the dimensions of the RapidHIT System?

A. The RapidHIT System weighs approximately 180 lbs (81.5 kg) and is 28 in (71 cm) depth x 28.5 in (73 cm) width x 19 in (48 cm) height.

Q. Is the RapidHIT System Portable?

A. The RapidHIT System is designed to withstand travel by airplane, truck and helicopter, and to be made ready to process samples within 60 minutes of placement at a site. No special environmental conditions are necessary beyond a stable surface and standard office/residential electrical service, as demonstrated by a recent US Department of Defense field exercise. An optional Pelican™ -type transport case will be available as an accessory, along with a mounting kit for securing a RapidHIT System in a vehicle.

Output

Q. Do you provide software for automatic report writing?

A. IntegenX does not provide custom software for automatic report writing. The RapidHIT System produces “FSA” as well as log files for compatibility with report writing software.

Q. Is the human identification data produced by the system compatible with national databases?

A.Yes.  The RapidHIT System uses the Promega Powerplex 16HS kit for CODIS STR analysis in the United States, and the Promega ESI kit for compatibility with the common European STR analysis format. The system embeds the SoftGenetics GeneMarker HID software program, which provides round-the-world compatibility with national databases. Alternative output file formats are also available for use with other STR analysis or LIMS systems.

Other

Q. Can the RapidHIT System be used for rapid microbial identification?

A. Currently the RapidHIT is focused on Human Identity using specific STRs (short tandem repeats) specified by the forensic community. The alleles used in the forensic community for human identity referred to as STRs, are a subclass of VNTRs (Variable Number Tandem Repeats) or microsatellites that involve repeats of 4 base pairs. There is no reason that the technology cannot be extended to identify microbes using VNTR-based probes that are available or as they become available.