Fully automated IVDR-certified platform for nucleic acid extraction and real-time PCR
Processes up to eight samples in 120 minutes with only 5 minutes of hands-on time
Full compatibility with lyophilised SMD Lead kits
Network up to six independent benchtop devices for scalability and flexibility.

Compact, user-friendly and fast: the geneLEAD^® VIII streamlines your workflow by delivering results for up to eight samples in just 120 minutes. Its fully automated process ensures ease of use, while networking up to six independent devices offers flexibility and scalability for daily lab needs. GeneLEAD^® VIII is IVDR certified for compliance with the latest regulatory standards¹ and includes HEPA filter and UV light for a robust contamination prevention.

Broad-spectrum pathogen detection

The SMD Lead Pathogen Detection Kits enable the qualitative detection of specific microbial pathogens in eluates from biological specimens:

respiratory (nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, and sputum),
gastrointestinal (stool samples),
dermatological (wound swabs, vesical lesion samples),
urogenital (genital swabs).

They are intended to aid in the diagnosis, screening, and monitoring of infections in both clinical and laboratory settings².

The geneLEAD^® system includes 8 independent, fully automated tracks, each consisting of:

Robust extraction module for separation of the nucleic acid using magnetic beads, from cellular materials, contaminants, and other impurities.
Independent real-time PCR module equipped with 6 fluorescent channels to detect all required SMD Lead Kits’ targets in one reaction mix.

Extraction and real-time PCR can be used either together or separately.
Results are analysed and reported directly using the geneLEAD^® software and can be accessed on the device’s laptop or remotely via the LIS system.”

Kit details:

Product number	Panel	DNA/RNA	Target details (organism, gene, channel)	Validated samples
S01147	C. diff	DNA	C. difficile – tcdA – FAM C. difficile – tcdB – Cy5	Biological specimen eluates
S01084	respiraRNA 3.0	RNA	Influenza A – M gene – FAM Influenza B – NEP gene – Cy5 RSV A/B – G gene – ROX	Nasopharyngeal swabs
S01086	gastroplexVirus	RNA/DNA	Norovirus GI/GII – RDRP gene – FAM Rotavirus – NSP3 – ROX Adenovirus – Hexon – Cy5	Stool samples
S01109	Bordetella	DNA	B. pertussis – IS481 – FAM B. parapertussis – IS1001 – ROX B. holmesii – hIS1001 – Cy5, IS481 – FAM	Nasopharyngeal swabs
S01114	MTC/NTM/MAC	DNA	M. tuberculosis complex – IS6110 – FAM NTM – 16S – Cy5 MAC – ITS – ROX	Respiratory, extrapulmonary samples
S01116	HSV/VZV	DNA	HSV-1 – US4 – FAM HSV-2 – US4 – ROX VZV – ORF6 – Cy5	Vesicle fluid, genital/oral swabs, CSF
S01129	respiraScreen 1	RNA	Influenza A – M gene – FAM Influenza B – NEP gene – FAM RSV A – G gene – ROX RSV B – G gene – ROX SARS-CoV-2 – E and S genes – Cy5	Nasopharyngeal swabs
S01140	MRSA seqc	DNA	SCCmec/orfX junction – FAM mecA and mecC – Cy5	Nasal swabs, wound swabs
S01144 (RUO)³	STI 1	DNA	C. trachomatis – ytfF – FAM M. genitalium – 16S – ROX N. gonorrhoeae – rpoC – Cy5	Genital swabs, urine

1 12 months stability in temperature range 2 - 28 ⁰C

2 These SMD lead kits are for in vitro diagnostic use as according to IVDD (Regulation 98/79/EC (IVDD). These test are for professional use only and is not intended for self-testing or over-the-counter use.

3 SMD lead STI 1 is for Research Use Only.

SMD Lead is manufactured by gerbion GmbH & Co. KG · www.gerbion.com
GeneLEAD^® is manufactured by Precision System Science Co., Ltd. · www.pss.co.jp

Technische Spezifikationen

Dimensions / weights W x H x D [mm / kg]	35 × 70 × 77 cm ( L W H ) 80 kg
Device Type:	Benchtop sample-to-result PCR system
Sample Throughput (Single Device):	Up to 8 samples (batch procedure)
Technology	Real-Time PCR
Detection System:	6 fluorescence channels (FAM, Channel 1; HEX, Channel 2; ROX, Channel 3; Cy5, Channel 4; TAMRA, Channel 5; Cy5.5, Channel 6)
Thermal Control:	An independently controlled thermocycler Temperature range: 40 to 99 °C Heating rate: 3-4 °C/sec Extraction temperature: approx. 65 to 80°C
Volumes	Sample volume: 200 μL Elution volume: 100 μL PCR volume: 25 μL
Laptop & Software	Notebook PC for geneLEAD® VIII including geneLEAD^® VIII Software LIS (Laboratory Information System) connectable included with geneLEAD VIII
Consumables	magDEA Dx SV Nucleic acid extraction cartridge (product no. E1300) geneLEAD VIII Consumable Set (product no. F8900) geneLEAD VIII PCR Reaction Cassette Set (product no. F8840) to be purchased separately
Power Supply:	AC 100-120 V or AC 220-240 V Frequency range: 50 Hz to 60 Hz Power consumption: approx. 400 VA
Contamination control	UV light decontamination HEPA filter

SMD Lead is manufactured by gerbion GmbH & Co. KG · www.gerbion.com
GeneLEAD^® is manufactured by Precision System Science Co., Ltd. · www.pss.co.jp

1 Compliant with In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746

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SMD Lead Kits

Clinical microbiology simplified - with reliable, lyophilised kits.

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