Specification builder · Tier C
Fully automatic immunoassay analyser (any test, any sample, any order) using chemiluminescence or electrochemiluminescence detection; benchtop 100 tests/hour as basic, 180 tests/hour as standard, 400+ tests/hour modular as advanced
A fully automatic analyser that measures hormones, vitamins, cardiac markers, tumour markers and hepatitis / HIV antibodies and antigens in serum or plasma, using antibody reactions read by emitted light (chemiluminescence or electrochemiluminescence). It is bought by DHQ and teaching hospital laboratories, cardiac institutes and private laboratory chains in Pakistan, often on reagent-rental contracts. It is an IVD medical device, every system runs only its maker's reagents, and the reagent cost per test decides the real price over the analyser's life.
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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 immunoassay analysers (moving probes, biohazardous samples, user information).
- IEC 61326-2-6 EMC requirements for IVD equipment, so photon-counting detection is 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.
- ISO 17511:2020 Requirements for metrological traceability of values assigned to calibrators and controls, for example to WHO international standards for hormones and tumour markers.
- CLSI EP15-A3 Protocol a lab uses to verify the manufacturer's precision and trueness claims at installation.
- CLSI EP17-A2 Protocol for limit of blank, limit of detection and limit of quantitation, essential for high-sensitivity troponin and low TSH.
- CLSI EP07 Guideline for interference testing, used to declare effects of biotin, haemolysis, lipaemia, bilirubin and other substances on each assay.
- 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: immunoassay systems are closed, so the reagent price per test decides the real cost for years. Evaluate total cost over 5 years using cost per reportable test (including calibrators, controls, reruns and expiry losses) for the lab's real test mix.
- Naming one maker's detection chemistry, incubation time or reagent pack format as a requirement, which excludes all other makers without improving results; ask for measured performance instead.
- Asking for 'troponin' without requiring a true high-sensitivity assay to IFCC criteria, so an older contemporary assay is accepted and early heart attacks are missed or the fast rule-out pathway cannot be used.
- Registering only the analyser with DRAP but not every reagent, calibrator and control, leading to customs holds and stock-outs of single assays after installation.
- Ignoring pack size and on-board stability: 100-test packs of rarely ordered assays (for example AMH or CA 15-3 in a small lab) expire before use, so the real cost per test can double.
- No cold-chain clause: reagents shipped or stored above 8 deg C in summer still give results, but wrong ones, and the lab cannot prove the cause.
- 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.
- Not asking bidders to declare biotin interference and hook-effect limits, so falsely normal thyroid results in patients taking biotin, or falsely low tumour markers at very high levels, go unnoticed.