Specification builder · Tier C
Fully automatic random-access clinical chemistry analyser with photometric and optional integrated ISE (Na, K, Cl) measurement; benchtop 200 tests/hour as basic, 400 tests/hour as standard, 800+ tests/hour modular as advanced
A fully automatic analyser that measures routine biochemistry (glucose, kidney and liver tests, lipids, enzymes, proteins) by photometry and, with an ISE module, sodium, potassium and chloride, running many tests on many samples in any order. It is bought by DHQ / THQ and teaching hospital laboratories and by private laboratory chains in Pakistan. It is an IVD medical device, so the analyser and its reagents must be registered with DRAP, and the reagent contract usually costs more than the analyser.
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Standards this specification draws on
- IEC 61010-1 Basic electrical, mechanical and fire safety for laboratory equipment, including IVD analysers.
- IEC 61010-2-101 Particular safety requirements for IVD medical equipment such as automatic chemistry analysers (sample probes, biohazard, user information).
- IEC 61326-2-6 EMC requirements for IVD equipment, so results are not disturbed by mains noise and nearby equipment.
- ISO 13485:2016 Quality management system standard for the manufacturer of the analyser and its reagents.
- ISO 15189:2022 Medical laboratory accreditation standard; requires verification of performance, internal QC, EQA and metrological traceability before patient use.
- CLSI EP15-A3 Protocol a lab uses to verify the manufacturer's precision and trueness claims at installation.
- CLSI EP06 Protocol for checking linearity and the reportable range of each assay.
- CLSI EP09c Protocol for comparing the new analyser with the existing method or a reference laboratory.
- CLSI C24 Statistical QC principles (Levey-Jennings, multi-rules) for daily control of the analyser.
- CLSI GP40-A4-AMD Defines clinical laboratory reagent water (CLRW) quality needed by chemistry analysers for washing and dilution.
- CLSI LIS1/LIS2 (ASTM E1381/E1394) and HL7 v2.x Standard communication protocols for connecting the analyser to an LIS.
- DRAP Medical Devices Rules 2017 Pakistan law requiring registration or enlistment of IVD analysers and their reagents before import and sale.
Common mistakes in tenders for this equipment
- Comparing only the analyser price: a cheap closed-system analyser can cost far more over 5 years. Evaluate total cost of ownership using cost per reportable test (including calibrators, controls, reruns, dead volume and on-board wastage) for the lab's real test mix.
- Accepting a throughput figure that includes ISE tests as if it were the photometric speed; '400 tests/hour with ISE' is often only 200 photometric tests per hour.
- Copying one maker's exact wavelength list, number of cuvettes, reagent pack format, sample-volume range or dimensions into the specification, which excludes every other maker without improving results.
- Registering only the analyser with DRAP but not its reagents, calibrators, controls and ISE solutions, leading to customs holds and reagent stock-outs after installation.
- Leaving out water purification, UPS and air-conditioning: analysers fail or give drifting results in hot rooms with poor water and unstable power.
- Reagent-rental 'free analyser' deals without a price cap per test, uptime guarantee, backup arrangement and no-minimum-purchase clause, leaving the lab locked in for years.
- Ignoring pack size and on-board stability: large packs of rarely used tests (for example lipase or magnesium in a small lab) expire on board, so the real cost per test can be double the quoted price.
- Demanding an integrated immunoassay module or track connection in the same lot as a routine chemistry analyser when it is not needed, which shrinks competition to two to four makers.