The geneLEAD VIII, distributed by Diagenode Diagnostics in Europe, is a new all-in-one automated molecular diagnostics platform for infectious diseases testing and much more… The geneLEAD VIII represents a unique CE-IVD solution to support the clinical microbiology laboratories in their daily challenges.
Comprehensive CE-IVD solution
From patient to result in less than 2 hours
Easy-to-install (3 days training)
This instrument named geneLEAD VIII is manufactured by Precision System Science (PSS), company focused on Life Science and In Vitro Diagnostics automated systems for more than 34 years. This instrument is designed to carrying out small series of tests (1.000 to 4.000 tests/year), from nucleic acid extraction to patient result in 1.5 hour. It provides 8 independent tracks to perform up to 8 different samples/tests in parallel: extraction only, amplification only or extraction and amplification. Its unique robotic arm, movable on a single axis, guarantees a strong reliability and robustness and therefore maximum availability in the laboratory. Six fluorescent channels are available for real-time monitoring (FAM, HEX, Rox, TAMRA, Cy5 and Cy5.5) allowing the development of complex multiplex assays. The geneLEAD VIII also includes a complete contamination prevention and control system (UV, HEPA filter, secure door closure, consumables design...). Its small footprint (77 x 35 x 70 cm) represents a real plus in the laboratory allowing the connection of 6 instruments to one PC in a limited space (48 tests in parallel) and then support the potential increase of test volumes.
Samples, reagents and consumables are placed in the instrument (see figure below, Step 1) and the run starts with automatic checks based on QR code scan (Step 2). Nucleic acids are obtained from the samples using magnetic bead extraction with process happening in the tip instead of a well. This nucleic acid extraction is based on the proprietary Magtration® technology (PSS) to automate the reaction by means of magnetic particles (see diagram below). It is a universal protocol (25 minutes) validated on a large number of sample types including : whole blood, serum, plasma, urine, cerebrospinal fluid, swab, sputum and stool. Upon completion the nucleic acids are transferred to the PCR well, the PCR master mix is added and amplification starts (Step 3). Results are then analyzed in real time, reported directly by the instrument and can be accessed remotely using LIS system already implemented in the laboratory (Step 4). Extracted samples can be recovered and stored for further investigation.
Based on the expertise in the development of molecular diagnostic assays acquired over the last 15 years, Diagenode Diagnostics introduces the first multiplex kits for the geneLEAD VIII, focused on respiratory and gastrointestinal infections, including :
The geneLEAD VIII represents a comprehensive CE-IVD solution resulting from the perfect synergy between the all-in-one instrument and the CE-IVD marked assays.
The geneLEAD VIII also provides an Open Mode for the development of homebrew assays based on real-time PCR and other detection chemistries (FRET, SYBR Green…). The Open Mode is an intrinsic functionality of the instrument, requiring no prior unlocking. The laboratory has access to a large number of parameters during the extraction and the amplification (pre-processing protocol, elution volume, PCR mix volume, extract or control volume, choice of enzyme and PCR profile, reagent concentration, script used, fluorescence channels…) in order to optimize the homebrew tests on the geneLEAD VIII. These homebrew tests can be validated and converted from the Open Mode (Ct values) to the Close Mode (Status, approval and traceability). This functionality facilitates the continuation of the homebrew assays currently used in the clinical microbiology laboratories, especially for pathogens without existing commercial kit yet.
1.5 to 2.5 hour/ run (according to DNA or RNA)
1.000 – 4.000 tests / year
Minimal experience with MDx required
H: 77 cm, D: 70 cm, W: 35 cm
AC100-240V ±10%, 50/60Hz, 300VA
Whole blood, Serum, Plasma, Urine, CSF, Swab (same protocol), Sputum and stool
50, 100 or 200 μL
Independent 8 tracks PCR
40 - 99°C
± 0.3°C (60 – 95°C）
6 (1. FAM, 2. HEX, 3. Rox, 4. TAMRA, 5. Cy5, 6. Cy5.5)
20 - 50 μL / reaction
Real time PCR and melting analysis (SYBR green, Taqman, Hyb-probe…)
For specific information on geneLEAD VIII availability for sale in a particular country, please contact your local Diagenode representative or write an email to firstname.lastname@example.org