NHLS seeks a supplier to place a HPLC-based haemoglobinopathy analyser at Groote Schuur Laboratory, Cape Town, including five-year service and maintenance. Bidders must meet strict technical requirements, including ISO 13485 manufacturer certification, IMDRF regulatory approval, and an 80% functionality threshold.
The National Health Laboratory Service (NHLS), a public health laboratory service with facilities across South Africa, has issued Tender RFB225/25/26 for the placement of a haemoglobinopathy analyser at its Groote Schuur Laboratory in Cape Town, together with a comprehensive five-year service and maintenance contract. The analyser is required for the diagnosis and management of haemoglobin disorders, including structural variants such as HbS, HbC, HbD and HbE, and quantitative conditions such as thalassaemia. The required method is ion-exchange High-Performance Liquid Chromatography (HPLC), which is the accepted standard for separating and quantifying haemoglobin fractions (HbA, HbA2 and HbF).
The technical specification is detailed and mandatory. Key requirements include an analyser footprint of no more than 550 mm x 550 mm x 550 mm, sample stability of at least four days in EDTA, on-board reagent tracking with a minimum 30-day open-vial stability, and a data storage capacity of at least 2,500 patients. The instrument must generate PDF output containing specified raw data fields, be interfaced with the NHLS Laboratory Information System with barcode reading, and support paediatric and adult sample preparation. Performance requirements include CV below 2% for HbA2 and below 5% for HbF, sample run times under 15 minutes for the highest score, and daily maintenance below 30 minutes. Successful bidders must also demonstrate sustained satisfactory performance in an internationally recognised external quality assurance programme, such as UK NEQAS or RCPA, across four consecutive cycles per year over 24 months. Local South African validation data is scored, and the analyser must be approved by at least one IMDRF-listed regulatory authority.
Contract conditions require a guaranteed UPS with at least 30 minutes' backup, on-site and super-user training, application specialist support for the contract duration, a telephone response within two hours, and on-site engineer support within eight hours. All prices must be firm, fixed and VAT inclusive, covering delivery, installation, site preparation and five years of service. Evaluation follows the 80/20 PPPFA preference point system, with 80 points for price and 20 for B-BBEE specific goals, after a minimum functionality threshold of 80% is met. Compulsory briefing attendance is required, and mandatory documents include a valid tax clearance, CSD registration, audited financial statements not older than two years, and an ISO 13485 certificate. The bid closes on 20 November 2026 at 11:00, with bids valid for 180 days.
Suitable for manufacturers, authorised distributors, and accredited suppliers of HPLC-based haemoglobin analysers or clinical diagnostic laboratory equipment, particularly those holding ISO 13485 certification and IMDRF-recognised regulatory approval. Bidders must have the capacity to provide long-term technical service, LIS integration, EQA participation evidence, and local engineering support in the Western Cape. Medical device distributors with proven South African service networks and B-BBEE-compliant businesses are strongly positioned to compete. Small and black-owned enterprises may claim specific goals points, but only if they can meet the stringent technical and regulatory requirements.
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