GeneXpert® IV: Automated in vitro diagnostic system for clinical laboratories
The GeneXpert® IV is a molecular diagnostic instrument designed to automate and integrate the critical steps of real-time PCR testing: sample preparation, nucleic acid amplification and target sequence detection. This system is intended for use in a laboratory or near-patient testing environment by trained professionals or under technical supervision.
The GeneXpert IV model includes up to four modules, each capable of processing a sample independently. This allows multiple tests to be performed simultaneously, even with different test definitions. Each module accepts Cepheid's Xpert® cartridges, which contain the reagents necessary for lysis, extraction and amplification of genetic targets.
Modular design and intuitive touchscreen interface
The system consists of a GeneXpert IV instrument and an integrated touchscreen unit. The user interface is simple and intuitive, with an integrated LED barcode scanner to facilitate sample and cartridge identification. The rear panel of the system includes Ethernet ports for instrument connection, USB, HDMI and DisplayPort ports, as well as a restart button and a main power switch.
Cepheid OS software version 2.1 enables test, user, results and security settings management. It supports up to 16 modules and offers features such as results export, ADF file management, network configuration, disk encryption and connectivity with LIS/POCT systems.
Performance, safety and regulatory compliance
The GeneXpert IV is CE, UKCA and IVD certified and complies with IEC/EN 61326 standards for electromagnetic emissions and immunity. It is designed for indoor use, with operating conditions between 15 and 30°C and relative humidity of 10 to 90% without condensation. The system is equipped with cleanable and replaceable fan filters and complies with environmental guidelines such as RoHS and REACH.
In terms of safety, the system incorporates protections against biological, chemical and electrical hazards. Used cartridges must be disposed of in accordance with medical waste management protocols. The barcode scanner is classified as "risk group exempt" according to IEC 62471:2006.
The GeneXpert IV is also compatible with Cepheid C360 software for viewing aggregated and anonymised medical data, and can be connected to a network via Ethernet or Wi-Fi.
