Objectives

The primary objective of this tender is to procure placement of Human Papilloma Virus (HPV) nucleic acid testing analysers for cervical screening across the National Health Laboratory Service (NHLS) network. The solution must include the supply, installation, service, and maintenance of automated HPV testing analysers for a period of three years, supporting the national cervical cancer screening program by enabling high-volume, accurate detection of high-risk HPV genotypes.

Scope

The scope encompasses:

• Provision of HPV nucleic acid qualitative detection analysers suitable for high-volume testing (>300 samples per 8-hour shift).
• Placement of testing analysers in existing and new laboratories across various provinces, including Gauteng, Eastern Cape, Limpopo, and others, to meet forecasted testing volumes over three years.
• Supply of all necessary reagents, consumables, calibration, and quality control materials.
• Implementation of result interfacing with Laboratory Information Systems (LIS).
• Provision of comprehensive service, maintenance, and support for three years.
• Training of laboratory personnel on the operation and maintenance of the analysers.
• Adherence to technical, environmental, and safety standards as specified in the tender documentation.

Technical Requirements

The technical specifications include, but are not limited to:

• Assay must detect high-risk HPV genotypes, including HPV 16, 18, 45, and others, with results reported separately or combined as specified.
• Assay performance must demonstrate a clinical sensitivity of ≥90% for CIN 2 and ≥95% for CIN 3, and a clinical specificity of ≥98%.
• The system must be modular, enabling testing of both high and medium sample volumes.
• Result data must interface seamlessly with LIS and support electronic data retrieval in CSV or equivalent formats.
• Assay must include specimen adequacy controls utilizing housekeeping genes and incorporate contamination prevention measures.
• Instrument weight should not exceed 500 kg per square meter footprint.
• Throughput should support at least 300 samples per 12 hours, with minimal hands-on time.
• Assay performance must be validated through external evaluations, with reproducibility and linearity data available.
• Support remote monitoring, software updates, and ongoing R&D commitments.
• Environmental impact considerations, including liquid waste management and hazardous materials handling.

Skills and Skills Requirements

The successful bidder must demonstrate:

• Expertise in molecular HPV testing technology and automation systems.
• Proven experience in deploying high-volume HPV testing analysers in a laboratory setting.
• Capability to provide comprehensive training to laboratory staff, including on-site user training within two weeks of installation and ongoing ad hoc training.
• Ability to provide prompt technical support, including telephonic support within one hour and on-site support within 24 hours.
• Strong project management skills to coordinate installation, validation, and commissioning across multiple sites.
• Experience in quality assurance, validation, and interfacing with LIS systems.
• Commitment to R&D, software development, and continuous improvement of the assay platform.
• Environmental and safety compliance expertise, including waste management and contamination control.

Summary

This tender aims to establish a reliable, high-capacity HPV testing infrastructure nationwide, supporting early detection and prevention of cervical cancer through advanced molecular diagnostics. The technical and skills requirements ensure the deployment of validated, efficient, and compliant testing solutions with robust support and training capabilities.