Objectives

The primary objective of this tender is to procure and implement the placement of Human Papilloma Virus (HPV) nucleic acid testing analysers for cervical screening across the National Health Laboratory Service (NHLS) nationally. The contract includes the supply, installation, and commissioning of HPV testing analysers, as well as providing comprehensive service and maintenance for a period of three (3) years to ensure continuous, reliable testing capacity.

Scope

The scope encompasses:

• Provision of HPV nucleic acid testing analysers capable of detecting high-risk HPV genotypes.
• Deployment of testing equipment across multiple NHLS laboratories nationwide, including existing and new laboratories in Gauteng, Eastern Cape, Limpopo, and other provinces.
• Integration of analysers with Laboratory Information Systems (LIS) for result interfacing.
• Training of personnel on operation and maintenance of the analysers.
• Provision of preventative maintenance, repairs, spare parts, and software updates over the three-year contract period.
• Supply of reagents, consumables, controls, and calibration materials necessary for HPV testing.
• Ensuring compliance with technical specifications, quality standards, and regulatory requirements.

Technical Requirements

The technical specifications include:

• Assay based on detection of high-risk HPV nucleic acids with the ability to detect all specified targets, either separately or in combination.
• Modular solution supporting high-volume (>300 samples/8-hour shift) and medium-volume testing (100-200 samples/8-hour shift).
• Result interfacing capability with LIS, with data export options (CSV or equivalent).
• Inclusion of specimen collection adequacy controls using housekeeping genes.
• Assay performance with clinical sensitivity of ≥90% for CIN 2 and ≥95% for CIN 3, and specificity of ≥98%.
• Instrument weight not exceeding 500 kg per square meter footprint.
• Automation features including contamination prevention, quality control, and contamination detection methods.
• Assay throughput of at least 300 tests per 12 hours, with robustness and reliability demonstrated through mean runs/tests till failure (target ≥200 hours MTBF).
• Remote monitoring and data management via dashboards, with capabilities for trend analysis and quality assurance.
• Environmental safety compliance (ISO 14001), occupational health and safety standards (OHS), and regulatory approvals (IMDRF or equivalent).
• Support for assay validation, calibration, and ongoing quality assurance processes.

Skills and Skills Requirements

The successful bidder must demonstrate:

• Technical expertise in molecular diagnostics, particularly HPV nucleic acid testing.
• Experience in deploying and supporting automated laboratory analysers in high-throughput settings.
• Capability to provide comprehensive on-site and remote technical support, including telephonic support within 1 hour and on-site support within 24 hours.
• Qualified personnel with relevant certifications and training in laboratory instrumentation, maintenance, and troubleshooting.
• Proven track record in servicing and maintaining similar diagnostic equipment in a healthcare or laboratory environment.
• Ability to provide training, documentation, and ongoing technical support to NHLS staff.
• Compliance with all regulatory, safety, and quality standards applicable to medical laboratory equipment.
• Capacity to deliver and support reagents, consumables, and calibration materials over the contract duration.

In summary, the tender seeks a technically proficient and experienced supplier capable of delivering reliable HPV testing analysers, integrated with existing laboratory systems, supported by comprehensive maintenance and technical support, to enhance cervical cancer screening efforts across South Africa.