Genetic Analysis S8-044 A1 Genomic DNA Extraction System Installation Guide
- June 17, 2024
- Genetic Analysis
Table of Contents
Genetic Analysis S8-044 A1 Genomic DNA Extraction System Installation Guide
OVERVIEW
This guide provides the information required to prepare a laboratory for performing the GA-map® Dysbiosis Test Lx v2 assay. Requirements for instruments, materials, and reagents are described.
INSTALLATION CHECK LIST
The following installation checklist summarizes the elements that must be completed during the installation phase. Mark each item as it is completed. Once these prerequisites have been met, please contact Genetic Analysis AS to schedule the training.
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Instruments and consumable items for Step 1 Genomic DNA extraction (see tables on page 4-6) must
be acquired -
Instruments and consumable items for Step 2 Amplification of the bacterial 16S rRNA gene – Step 6 Hybridization and Signal Detection (see tables on page 6-9) must be acquired
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All instruments, including the Luminex detection system, must be installed and ready for use
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Operators must have been trained in use and maintenance of the Luminex detection system
RECOMMENDED SAFETY EQUIPMENT
Fecal samples should be treated as potentially infectious material until inactivation and require the use of BSL-2 grade laboratory equipment and precautions. This involves the use of appropriate PPE, biological safety cabinet, proper waste disposal and risk-minimizing routines for sample handling. Make sure to follow laboratory and local guidelines for EHS.
COMPUTER REQUIREMENTS
The GA-map® Analyzer is a cloud-based software compatible with most web browsers. See the GA-map® Analyzer Manual for details.
LABORATORY REQUIREMENTS
The GA-map® Dysbiosis Test Lx v2 requires a typical molecular laboratory set-
up. It is recommended that the laboratory contains, at a minimum, dedicated
pre-PCR, template-free, and PCR/post-PCR zones. The zones should be separated
to prevent contamination.
The table below contains an overview of the different laboratory procedures
that are performed in the individual zones, in addition to instruments and
equipment needed in the different workstations. Please refer to the
Equipment, materials, and reagents required section for equipment
specifications. To equip the lab with appropriate pipettes, please refer to
the IFU for volumes to be pipetted.
EQUIPMENT, MATERIALS, AND REAGENTS REQUIRED
The lists below describe the required equipment, materials, and reagents for the GA-map® Dysbiosis Test Lx v2.
All items are required, unless otherwise specified. Genetic Analysis must be informed of any deviations from these requirements and a separate validation might be necessary.
The quantity for all equipment is based on the set-up described in the
Laboratory Requirements section above.
It should be noted that different laboratory set-ups (e.g. with additional
zones) might affect the quantity.
FOR STEP 1 – GENOMIC DNA EXTRACTION
List of equipment when extracting DNA according to STEP 1 of the IFU – need of
equipment may vary with choice of extraction kit and instruments.
List of materials
List of reagents
FOR STEP 2 – AMPLIFICATION OF THE BACTERIAL 16S RRNA GENE TO STEP 6 – HYBRIDIZATION AND SIGNAL DETECTION
List of equipment
*Additional items for use and maintenance are required: kits for calibration and performance verification, sheath fluid or drive fluid, and an ultrasonic bath (40-60 kHz)
List of materials
List of reagents
TRAINING PLAN
Training will be scheduled following system set-up. Genetic Analysis will train users in performing the process of GA-map® Dysbiosis Test Lx v2 from fecal gDNA extraction (or from PCR, if the extraction method differs from that described in the IFU) to generation of the reports. Other sampling devices, extraction instruments and chemistry can be validated upon request using our standardized validation method. Basic instrument operation and use of the software will be included in the training. Those being trained will be required to have a basic knowledge of Microsoft Windows and use of general laboratory equipment and tools.
Operators must have been trained in use and maintenance of the Luminex system prior to the tech transfer.
CONTACT INFO
We are happy to help you with your inquiries.
Technical Support: [email protected]
Genetic Analysis AS | Ulvenveien 80 | 0581 OSLO | Norway
www.genetic-analysis.com | Phone: +47 48 32
16 10 | E-mail: [email protected]
Registered names, trademarks, etc. used in this document, even when not
specifically marked as such, are not to be
considered unprotected by law. All trademarks and registered trademarks
mentioned herein are the property of their respective owners.
© 2021-2023 Genetic Analysis, all rights reserved.
S8-044 A1 v9 Appendix 6