Laboratory - Technical Specifications

Genex Diagnostics operates in accordance to an established Quality System which is ISO 17025 and AABB accredited. Genex's Quality System surpasses all of the stringent requirements set forth for ISO 17025 and the AABB Parentage Testing Program. All revised techniques and protocols which have been developed in Genex Diagnostics are subjected to rigorous internal testing and are in compliance with the accreditation bodies.

Screening and Extraction

The laboratory follows written and established protocols for all technical procedures.

1. Amplification mix procedures are performed under a dedicated sample handling containment hood.
2. Equipment for DNA extraction, including micro-pipettes, aerosol resistant pipette tips, scalpels, scissors, and extraction reagents are dedicated for use in DNA extraction and properly cleaned or disposed of where appropriate.
3. Disposable gloves and surgical masks are worn during extraction and amplification procedures.
4. Dedicated lab coats are worn for pre-amplification sample handing, and when working in the extraction area.
5. Scissors/scalpels are cleaned with alcohol swabs after cutting each evidence sample.
6. Pipette tips are changed between each sample even when dispensing reagents.
7. To reduce the potential of aerosols, the last bit of sample from a pipette is not "blown out". Each extract will have a reagent blank.
8. All extraction procedures exceed accreditation requirements.

Analytical

The protocols used in DNA purification, amplification, and separation follow the strict requirements of the Genex Quality System.

All PCR reactions are set up in designated sample handling hoods. Designated pipettors are assigned for PCR use only. Plugged aerosol resistant tips are used to set up all reactions.

PCR products are analyzed using ABI Prism Genetic Analyzers.

Allele Designations

Data obtained using the Genescan software are converted to the appropriate genotype using Genotyper Software and far exceed quality assurance requirements. The laboratory implements full testing of 16 loci for all casework. The 16 loci tested contains the full set of 13 core STR loci and more.

Equipment and Instrumentation

Genex is fully equipped with all of the instruments necessary for performing advanced DNA casework. The state-of-the-art DNA Identity Testing laboratory is equipped with multiple GeneAmp thermocyclers, PCR work areas, separation of pre and post amplification work stations, and multiple ABI Prism Genetic Analyzers (all equipped with Genescan and Genotyper software). The laboratory is equipped with locking freezers, refrigerators, and storage units.