The geneLEAD^® VIII [1] is a fully automated molecular diagnostics platform that integrates nucleic acid extraction and real-time PCR in one streamlined system or as independent modules. Together with lyophilised SMD lead kits [2], it ensures reliable high-quality results, minimal hands-on time, and reduced costs.

Designed for diagnostic laboratories, geneLEAD^® VIII bridges the gap between point-of-care solutions and high-throughput systems with a large footprint – offering both flexibility and dependable performance in a compact format across a wide range of applications.

Why labs choose geneLEAD® VIII and SMD lead kits?

Proven performance

Rapid results: 120 min turnaround, < 5 min hands-on time
1–8 samples per run with LIS integration
6-channel multiplex PCR
Reproducible, validated results
HEPA filter + UV light for contamination control
Lyophilised reagents – room-temperature storage

Integrated internal controls

Internal sample control (ISC): ensures sample collection and sample integrity
Internal process control (IPC): detects PCR inhibition within each reaction

EQA [3]-validated accuracy

100% concordance as verified by QCMD & INSTAND tests

Modular system architecture

Nucleic acid extraction & PCR together or independent
Eluates compatible with NGS & downstream applications

Independent and scalable

Fits existing lab workflows
Up to 6 systems networked for higher throughput

geneLEAD VIII workflow

SMD lead kits menu

The growing portfolio of SMD lead kits provides ready-to-use, room-temperature-stable PCR assays covering a wide range of infectious diseases:

Respiratory panels

SMD lead respiraRNA 3.0: Multiplex RNA assay for rapid seasonal respiratory diagnosis
SMD lead respiraScreen 1: One test for flu, RSV, and COVID-19 in differential diagnosis
SMD lead Bordetella: Differentiates Bordetella species for accurate cough diagnosis
SMD lead MTC/NTM/MAC: Differentiates TB, NTM, and MAC in one test

Neurological and skin panels

SMD lead HSV/VZV: Differentiates herpesvirus infections in neurological and dermatological cases

Gastrointestinal pathogens

SMD lead C. diff: Rapid detection of toxigenic C. difficile
SMD lead gastroplexVirus: Multiplex detection of leading viral gastroenteritis pathogens

Hospital-acquired infections

SMD lead MRSA seqc: Direct detection of MRSA and resistance markers

Sexually Transmitted Infections

SMD lead STI1: Multiplex detection of bacterial STI pathogens
SMD lead STI2: Multiplex detection of parasitic and mycoplasmal STIs

Read the geneLEAD® VIII brochure

Download the brochure to explore the key benefits of geneLEAD® VIII

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Explore our molecular microbiology solutions

geneLEAD VIII

geneLEAD^® see the precision in action

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SMD Lead Kits

Clinical microbiology simplified - with reliable, lyophilised kits.

Details

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

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

[3] EQA – External Quality Assessment, QCMD & INSTAND – non-profit international EQA providers: QCMD (Quality Control for Molecular Diagnostics) – www.qcmd.org, INSTAND e.V. – www.instand-ev.de