Objectives

The primary objective of this tender is to procure and establish the placement of an Automated Extraction and Real Time PCR Open Platform Instrument, including reagents, consumables, and related services, for a period of five (5) years at the Infection Control Services Laboratory, Charlotte Maxeke Johannesburg Academic Hospital. The goal is to enhance diagnostic capabilities, improve turnaround times, and ensure reliable molecular testing for various pathogens.

Scope

The scope of the tender encompasses:

• Provision of an automated sample lysis, nucleic acid extraction, and real-time PCR setup system.
• Installation, calibration, validation, and commissioning of the instrument at the designated laboratory.
• Supply of reagents, consumables, and necessary accessories for a 5-year period, supporting specified volumes and assays.
• Training of laboratory staff on operation, maintenance, and troubleshooting of the system.
• Ongoing technical support, preventive maintenance, repairs, and spare parts for the duration of the contract.
• Integration with Laboratory Information Systems (LIS) and compliance with relevant standards.

Technical Requirements

The technical specifications include:

• Automated system capable of processing a minimum of 50 samples per 8-hour shift.
• Ability to perform detection of specific targets such as mecA, mecC, and other pathogens.
• Open system compatibility to use lab-developed or external kits, with inclusion of mandatory assays for 5 years.
• Cartridge-based or unitized reagent strip tests with multiplex and singleplex PCR capabilities.
• Temperature range: -40°C to 110°C with ±1°C accuracy.
• Computer interface with color printing, barcode scanning, and LIS connectivity.
• Reagents and consumables included for at least 5 years supporting specified monthly volumes.
• UPS with support batteries and surge protection to ensure uninterrupted operation during testing runs.
• Compliance with ISO 13485 and approval by recognized regulatory authorities.
• Maximum dimensions (excluding PC): specified in detailed technical annexures.
• Cross-contamination prevention measures and internal controls for assay validity.

Skills and Skills Requirements

The tender stipulates the following skills and personnel requirements:

• Qualified technical/engineering/support staff with relevant training and certifications, CVs or proof of competence to be provided.
• Onsite training for at least 6 laboratory staff members, with certification of competency issued.
• Availability of technical support engineers or application specialists on a 24-hour basis, including weekends and public holidays, with a response time of less than 24 hours for instrument breakdowns.
• Preventive maintenance scheduled and performed by qualified personnel, with documented schedules.
• Calibration and validation of instruments post-servicing or major repairs, performed by authorized engineers.
• Provision of ongoing training, technical support, and troubleshooting assistance as part of the service agreement.

Overall, the successful bidder must demonstrate capacity to provide skilled technical support, maintain high standards of operational competency, and ensure continuous system availability and performance throughout the contract period.