Q. What is the RapidHIT ?
A. The RapidHIT™ Human DNA Identification System is a fully automated, sample-to-answer instrument for producing STR DNA profiles from a variety of different sample types.
Q. How does the RapidHIT work?
A. The RapidHIT utilizes IntegenX®’s proprietary and patented MOVe valve technology with microfluidic chip technology to integrate DNA extraction, DNA purification, PCR amplification, and capillary electrophoresis into one instrument. To start a run, users load four disposable cartridges onto the instrument before inserting and naming samples. After 2 hours, users can retrieve analyzed data from the processed samples.
Q. What user skill level is required to operate the RapidHIT?
A. The RapidHIT’s icon-based user interface was designed to be operated by non-technical users such as police officers, military personnel, and evidence technicians. Before the RapidHIT was introduced, both sample processing and data analysis typically were performed by highly trained forensic DNA analysts. Now, after the RapidHIT’s introduction, the sample processing steps and basic data analysis can be performed by non-technical staff with minimal training in molecular biology or forensic laboratory procedures. The data can then be electronically transferred to forensic DNA experts to perform more advanced data interpretation, if required.
Q. What security and audit trail measures are in place on the RapidHIT System?
A. All user activities including login/out are recorded in a log file. Access is through password entry or a fingerprint scan. The designated “Administrator” will set up user accounts, privileges, and access levels on the RapidHIT during which passwords and fingerprints are established.
Q. How long does it take to run samples?
A. A run is completed in less than two hours including sample processing, amplification, separation and detection, STR data analysis and electropherogram results.
Q. How many samples can be processed at once?
A. RapidHIT users have the flexibility to process from one to seven samples simultaneously in self-contained disposable cartridges.
Q. Are accredited laboratories required to process a positive and negative control in each set of samples run on the RapidHIT?
A. While any RapidHIT user maintains the ability to run positive and/or negative controls on each run, neither is required on each run. Effective December 1, 2014, the United States FBI’s Addendum to the Quality Assurance Standards for DNA Databasing Laboratories performing Rapid DNA Analysis and Modified Rapid DNA Analysis Using a Rapid DNA Instrument states that “Standards 9.5.1 [quantitation standards], 9.5.2 [positive controls], and 9.5.3 [negative controls] shall not be required for a Rapid DNA instrument.” However, please check with your local regulatory body for current information.
Q. How many markers are analyzed on the RapidHIT?
A. RapidHIT users have the option between the NDIS-approved GlobalFiler® Express chemistry, which has 24 markers, and the NGM SElect™ Express chemistry, which has 17 markers.
Q. What sample types can be analyzed on the RapidHIT?
A. The RapidHIT can be used reliably to generate complete STR DNA profiles from reference samples as well as crime scene samples.
Sample types that have generated complete profiles on the RapidHIT:
• Bone marrow
Q. Is there a published developmental validation for the RapidHIT?
A. Yes. IntegenX has performed and published three developmental validations for the RapidHIT:
1. Developmental Validation of the GlobalFiler Express Kit, a 24-Marker STR Assay, on the RapidHIT System
2. Developmental Validation of a fully integrated sample-to-profile rapid human identification system for processing single-source reference buccal samples
3. Developmental Validation Studies on the RapidHIT™ Human DNA Identification System
Q. Does the RapidHIT comply with FBI Quality Assurance Standards (QAS) for rapid DNA systems approved for process and upload of samples into the Combined DNA Index System (CODIS)?
A. Yes, the RapidHIT does comply with the FBI standards for rapid DNA.
Q. Can the RapidHIT achieve single base-pair resolution?
A. Yes. IntegenX has repeatedly demonstrated better than single base resolution out to approximately 575 bases.
Q. What are the dimensions of the RapidHIT System?
A. The RapidHIT 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 data produced by the RapidHIT compatible with CODIS and other national DNA databases?
A. Yes. Files in CMF 3.2 format, the standard format for uploading data to CODIS, is one of many files generated on the RapidHIT. Alternatively, RapidHIT users can export other formats from the GeneMarker® HID software that ships with the instrument.
Q. Can data from the RapidHIT be uploaded to CODIS or other national DNA databases?
A. Yes. Reference DNA profiles generated on the RapidHIT can be uploaded to CODIS (when using the GlobalFiler® Express kit) and other national DNA databases.
In fact, the Arizona Department of Public Safety (AZ DPS) regularly uploads RapidHIT data from arrestees to CODIS in an attempt to link to previous crimes while in custody:
“Arizona Department of Public Safety is First NDIS Lab to Upload DNA Profiles to National Database Utilizing Rapid DNA” (May, 2015)
Similarly, Key Forensics Services (KFS) has successfully solved cases by uploading reference DNA profiles generated on the RapidHIT to the UK’s National DNA Database® (NDNAD):
“RapidHIT DNA Profile Uploaded to UK National DNA Database Identifies Dangerous Sex Offender While Suspect in Custody”(August, 2015)
Q. Who do I contact for sales, support, or training for the RapidHIT?
A. IntegenX Customer Service can be contacted by emailing firstname.lastname@example.org or by calling (888) 371-4749 or +1 (925) 701-3400.