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 providing service and maintenance for a period of three (3) years. The goal is to support the NHLS's program for early detection of HIV in infants, enabling timely initiation of treatment and reducing pediatric morbidity and mortality.

Scope

The scope encompasses:

• Supply and placement of the HIV Nucleic Acid Qualitative Detection assay across designated laboratories.
• Provision of comprehensive service and maintenance for three years.
• Implementation at specified laboratories, including East London (Frere) and Tshepong, with potential for other sites as per project requirements.
• Support for sample collection, processing, and reporting, including dried blood spot (DBS) collection kits.
• Training, technical support, and quality assurance measures to ensure optimal assay performance.

Technical Requirements

The assay and associated systems must meet the following technical specifications:

• Fully automated, closed platform/system detection within specified limits.
• Interface capability with Laboratory Information Systems (LIS) for seamless data management.
• Support for EDTA anticoagulated whole blood sample protocols.
• Compliance with environmental safety standards (ISO 14001) and Occupational Health and Safety (OHS) requirements.
• Approval by recognized regulatory authorities (e.g., IMDRF).
• Instrument weight, size, and storage conditions suitable for laboratory environments.
• Assay performance with a sensitivity of above 95%, specificity of 95-97.9%, and a low error rate.
• Throughput capacity of at least 5,000 specimens per month per laboratory.
• Availability of control materials, calibration, and maintenance support.
• Support for polyvalent platform capable of supporting other priority assays (e.g., HIV viral load, TB).
• Reliable power supply with UPS backup and surge protection.

Skills and Skills-Related Requirements

The successful bidder must demonstrate:

• Expertise in molecular diagnostic assay implementation, maintenance, and troubleshooting.
• Provision of comprehensive training for laboratory personnel, including initial and refresher courses.
• Availability of technical support staff with experience in HIV nucleic acid testing.
• Capability to provide remote monitoring, dashboard access, and performance reporting tools.
• Support for sample collection, processing, and data management, including barcode tracking and LIS integration.
• Provision of support for assay validation, quality control, and ongoing performance evaluation.
• Ability to supply and support DBS collection kits and reagents, with detailed documentation and compliance with safety standards.
• Experience in managing large throughput laboratories and supporting multiple sites with timely maintenance and repairs.

In summary, the bidder must possess strong technical expertise, proven experience in molecular diagnostics, robust support infrastructure, and the capacity to deliver a reliable, compliant, and high-performance diagnostic solution aligned with NHLS requirements.