Objectives

The primary objective of this tender is to procure and place a fully automated flow cytometer analyser at TAD, Nelson Mandela Academic Laboratory, and Port Elizabeth. The solution must include comprehensive quality control, consumables, service, and maintenance over a period of five (5) years, ensuring enhanced diagnostic capabilities, particularly for immunophenotyping and haematological malignancies, with improved turnaround times and service delivery.

Scope

The scope encompasses:

• Supply, installation, and commissioning of the flow cytometer analyser at specified locations.
• Provision of all necessary consumables, reagents, controls, and calibration materials.
• Implementation of quality control measures and data management systems.
• Training of laboratory personnel on operation, maintenance, and troubleshooting.
• Ongoing service, maintenance, and technical support for five (5) years.
• Integration with existing Laboratory Information Systems (LIS) and compliance with technical specifications.

Technical Requirements

The technical specifications and requirements include:

• Flow cytometer with a minimum of 10-color fluorescence detection capability.
• Throughput capacity of at least 25,000 events per second.
• Ability to handle a minimum of 1 million events for minimal residual disease (MRD) analysis.
• Automated colour compensation software for spectral overlap correction.
• On-board QC data management with Levy-Jennings plots, CVs, and SDs.
• Electronic reagent and consumable stock monitoring systems.
• Compatibility with existing LIS (e.g., TrakCare) for result transmission and data management.
• Provision of reagents, controls, and calibration materials at vendor’s cost.
• UPS with a minimum of 60-minute backup, surge protection, and training package.
• Operational software supporting multi-parameter analysis, including immunophenotyping, CD34 enumeration, PNH detection, and MRD.
• Interface capability with laboratory systems and remote analysis features.
• Availability of after-sales support, including trained engineers and application specialists within 12 hours.
• Compliance with ISO 13485 standards and approval by relevant regulatory authorities.
• Provision of detailed technical brochures, validation data, and evidence of compliance for all specifications.

Minimum scoring of 80% on the technical functionality evaluation is required to proceed to the next evaluation stage.

Summary

This tender aims to acquire a state-of-the-art flow cytometry analyser that meets specified technical standards, supports advanced diagnostic applications, and ensures reliable, ongoing support over five years, thereby enhancing laboratory diagnostic capacity and service delivery.