Specification builder · Tier C
Automated haematology analyser with 5-part white cell differential (CBC + 5-part DIFF); mid-throughput standard, high-throughput with slide maker/stainer as advanced
An automated blood-cell counter that gives the full blood count (CBC) and splits white cells into five types (neutrophils, lymphocytes, monocytes, eosinophils, basophils) within about a minute per sample. It is bought by hospital laboratories and private clinical laboratory chains in Pakistan, and is used for routine CBC, anaemia and thalassaemia work-up, infection and dengue monitoring, and screening of samples that need a blood film. It is an IVD medical device, so the analyser and its reagents must be registered with DRAP.
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Standards this specification draws on
- ISO 15189:2022 Medical laboratory accreditation standard; requires verification of analyser performance, internal QC and EQA participation before patient use.
- CLSI H26-A2 Defines how to validate, verify and quality-assure automated haematology analysers (precision, carryover, linearity, comparison).
- ICSH guidelines for evaluation of blood cell analysers (2014) International protocol for evaluating counts, differentials and reticulocytes; use it for installation acceptance.
- CLSI H20-A2 Reference manual differential method against which the automated 5-part differential is compared.
- CLSI H44-A2 Methods for reticulocyte counting, relevant when the reticulocyte option is ordered.
- CLSI C24 Statistical QC principles (Levey-Jennings, multi-rules) for daily control of the analyser.
- CLSI LIS1/LIS2 (ASTM E1381/E1394) and HL7 v2.x Standard communication protocols for connecting the analyser to an LIS.
- ISO 13485:2016 Quality management system standard for the manufacturer of the analyser and reagents.
- IEC 61010-1 / IEC 61010-2-101 and IEC 61326-2-6 Electrical safety and EMC requirements for IVD laboratory equipment.
- EU IVDR (EU) 2017/746 European IVD regulation; CE-IVD marking under it is common evidence of regulatory approval.
- DRAP Medical Devices Rules 2017 Pakistan law requiring registration / enlistment of IVD analysers and reagents before import and sale.
Common mistakes in tenders for this equipment
- Ignoring reagent cost: tenders that compare only the analyser price let a bidder win with a cheap machine and then charge high prices for closed, maker-only reagents. Always evaluate the total 5-year cost including cost per reportable test.
- Copying one maker's trademarked parameter names or channel names (for example a specific reticulocyte haemoglobin, fluorescent platelet or volume-conductivity-scatter term) into the specification, which excludes every other maker. Describe the clinical measurement instead.
- Asking for an exact parameter count (e.g. 'minimum 32 parameters') that can only be reached by counting research-use-only parameters, which cannot be reported to patients.
- Accepting throughput quoted in CBC-only mode; the real speed with differential, reticulocytes or body fluids can be half or less.
- Fixing an exact aspiration volume, analyser dimensions or number of reagents, which serves only to match one model without improving results.
- Registering only the analyser with DRAP but not its reagents and controls, leading to customs holds and reagent stock-outs after installation.
- 'Free analyser' reagent-rental placements without a written minimum service level, uptime guarantee and reagent price cap, leaving the lab locked in.
- Requiring an integrated slide maker or digital morphology in the same lot as a small analyser, which shrinks competition to one or two makers when it is not needed.