Objectives

The primary objective of this tender is to procure and implement HPV nucleic acid testing analysers for cervical screening across the National Health Laboratory Service (NHLS) nationally. The contract includes the supply, installation, commissioning, and ongoing service and maintenance of the analysers for a period of three years, aiming to enhance HPV screening capacity, accuracy, and efficiency in line with WHO and national health guidelines.

Scope

The scope encompasses:

• Provision of HPV nucleic acid testing analysers capable of detecting high-risk HPV genotypes.
• Installation and commissioning of equipment at multiple NHLS laboratories across South Africa, including six new laboratories in Gauteng, Eastern Cape, and Limpopo.
• Training of personnel on equipment operation and maintenance.
• Provision of comprehensive service, preventative maintenance, repairs, and spare parts for three years.
• Supply of reagents, consumables, controls, calibration materials, and software updates.
• Adherence to technical specifications, environmental and safety standards, and regulatory approvals.

Technical Requirements

The technical specifications include:

• Assay based on detection of high-risk HPV nucleic acids, capable of detecting all specified targets, either separately or combined.
• Modular design enabling testing of high (>300 samples/8-hour shift) and medium (100-200 samples/8-hour shift) volumes.
• Interface capability with Laboratory Information Systems (LIS) and electronic data access with CSV export.
• Inclusion of specimen adequacy controls, contamination prevention measures, and quality control features.
• Assay performance with clinical sensitivity: CIN2 ≥90%, CIN3 ≥95%; specificity ≥98%.
• Instrument weight not exceeding 500 kg per square meter footprint.
• Robust throughput, uptime, reproducibility, and environmental safety standards (ISO 13485, ISO 14001, OHS).
• Remote monitoring, data management dashboards, and support for software/hardware upgrades.
• Environmental impact considerations, including waste management and storage facilities.

Skills and Skills Requirements

The successful bidder must demonstrate:

• Technical expertise in molecular diagnostics, specifically HPV testing platforms.
• Capability to install, calibrate, validate, and support complex laboratory equipment.
• Provision of on-site user training within two weeks of installation and ongoing ad hoc training.
• Availability of qualified service engineers and application specialists, with telephonic support within 1 hour and on-site support within 24 hours.
• Experience in managing maintenance, calibration, and troubleshooting of high-throughput diagnostic analysers.
• Compliance with regulatory standards (ISO 13485, ISO 14001, OHS) and ability to provide relevant certification.
• Proven track record in supporting laboratory automation, data management, and quality assurance systems.
• Capacity to provide ongoing R&D support, software updates, and upgrades aligned with technological advancements.

In summary, the bidder must possess the technical capability, qualified personnel, and experience to deliver, support, and sustain advanced HPV testing analysers that meet the specified technical and quality standards, ensuring reliable and efficient cervical screening services for the NHLS nationwide.