Objectives

The primary objective of this tender is to procure the placement of an Early Infant Diagnosis (EID) Screening Assay for HIV Nucleic Acid Qualitative Detection, including service and maintenance, for a period of three years. The aim is to support the NHLS's HIV diagnosis program by providing reliable, efficient, and scalable testing solutions to facilitate early detection of HIV in infants, thereby enabling timely treatment and reducing pediatric morbidity and mortality.

Scope

The scope encompasses:

• Provision and placement of the HIV Nucleic Acid Qualitative Detection assay across designated laboratories, including East London (Frere) and Tshepong.
• Supply of all necessary hardware, reagents, consumables, and collection kits (e.g., dried blood spot kits).
• Implementation of the assay platform supporting high throughput and integration with Laboratory Information Systems (LIS).
• Provision of comprehensive service, maintenance, and technical support for three years.
• Training of laboratory personnel and ongoing quality assurance measures.
• Adherence to specified technical and functional requirements, including assay performance, safety, and environmental standards.

Technical Requirements

The bid must demonstrate compliance with the following technical specifications:

• Assay platform must be fully automated, closed, and interfaceable with LIS.
• Capability to process at least 5,000 specimens per month per laboratory, with multiple systems if needed.
• Reagents and consumables must be stable, with shelf life >12 months, stored at +2°C, and compatible with barcode tracking.
• Assay performance must include:
• LOD for HIV-1: 20-50 copies per input volume.
• Clinical sensitivity ≥95% at the LOD.
• Specificity ≥95%.
• High assay accuracy with intra- and inter-assay CV below acceptable thresholds.
• Assay platform should support multiple HIV subtypes/recombinants.
• Assay turnaround time: within 4 hours for urgent specimens.
• Environmental safety and occupational health standards must be met (ISO 14001, OHS).
• Availability of maintenance support, spare parts, and technical training.
• System must include error tracking, troubleshooting codes, and quality control monitoring tools.
• Assay platform should be polyvalent, supporting other priority assays (e.g., HIV viral load, TB).

Skills Requirements

The successful bidder must demonstrate:

• Expertise in molecular diagnostics, particularly HIV nucleic acid testing.
• Proven experience with high-throughput laboratory automation platforms.
• Capability to provide comprehensive technical support, including remote monitoring, troubleshooting, and on-site maintenance.
• Qualified personnel trained in assay operation, maintenance, and quality assurance procedures.
• Ability to deliver ongoing training and capacity building for laboratory staff.
• Strong project management skills to ensure timely deployment, integration, and support across multiple sites.
• Compliance with all relevant regulatory standards and environmental safety requirements.

In summary, the bidder must provide a technically compliant, scalable, and sustainable solution with demonstrated expertise and capacity to support the NHLS's early infant HIV diagnosis program over the three-year contract period.