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hematologyanalyser.myby AA Alive Sdn Bhd
ENBM

Also called: Method verification, Analyser validation, MS ISO 15189

Verifying a New Haematology Analyser Before Patient Testing

The maker has proved the analyser can perform. Verification proves it performs in your lab, with your staff and your patients. A practical plan for clinics and accredited labs.

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Validation or verification?

Validation — the manufacturer

The maker establishes the analyser’s performance claims — precision, linearity, carryover, flagging — through studies used for regulatory approval.

Verification — your lab

Before reporting patient results, the lab confirms it can achieve those claims in its own setting. MS ISO 15189 requires this for accredited labs, and it is good practice for any clinic.

Plan before you start

  • Write a verification plan listing each study, the number of samples and the acceptance criteria.
  • Take acceptance criteria from the maker’s claims or from recognised performance specifications, and fix them before you see the data.
  • Use the reagent, control and calibrator lots you will use in routine work.
  • Recognised protocols help: CLSI EP15 is commonly used for precision and trueness, and ICSH publishes guidance on evaluating blood cell analysers.

The core studies

StudyWhat you doWhat it shows
RepeatabilityRun the same samples (low, normal and high) many times in one runShort-term precision for each parameter
Within-lab precisionRun controls or samples over several days — EP15 uses 5 replicates on 5 daysDay-to-day variation under routine conditions
Method comparisonRun patient samples across the reportable range on the new analyser and the current method or reference labBias against the results clinicians are used to
CarryoverRun a high sample three times, then a low sample three timesWhether a high result contaminates the next sample
Linearity and reportable rangeRun a dilution series of a high sample, including low platelet and white-cell levelsOver what range results can be reported
FlaggingCompare analyser flags with blood films on abnormal samplesHow often flags miss or over-call abnormal cells

Carryover, step by step

Following the ICSH approach, run a sample with high counts three times (H1, H2, H3) and then a sample with low counts three times (L1, L2, L3). Carryover (%) = (L1 − L3) ÷ (H3 − L3) × 100. Compare the figure for WBC, RBC, HGB and PLT with the maker’s claim. Low carryover matters most where a very high count can be followed by a very low one, such as a leukaemia sample followed by a neutropenic patient.

Reference intervals and sample modes

  • Verify any reference intervals you adopt from the maker or another lab with a small group of healthy local individuals before using them; establish your own if they do not fit.
  • Verify each sample mode you will use — venous whole blood, pre-diluted capillary, body fluid — separately.
  • Pay attention to low platelet counts, which drive dengue management.
  • Check that results, units and flags arrive correctly in the LIS or clinic system.

Read next Validating the LIS link

Records and after go-live

  • Keep the plan, raw data, statistics, conclusion and the sign-off by the person responsible for the lab.
  • Repeat a reduced verification after relocation, a major repair or a software change, as your quality procedures specify.
  • From day one, run internal QC and enrol in EQA so performance is monitored continuously.
  • The supplier’s application specialist can help run the studies, but the lab owns the acceptance decision.

Read next Daily QC after verification

Related guides

Haematology Analyser Quality Control and CalibrationThe routine that keeps every FBC result trustworthy — from the morning control run to external quality assessment and accreditation.Refurbished Hematology Analyzer: What to Check Before Buying UsedA second-hand FBC machine can look cheap on day one. These checks show whether it will still be cheap — and reliable — a year later.Haematology Analysers for Hospital and High-Volume LabsAt hospital volumes, the questions change from “3-part or 5-part?” to throughput, automation, uptime and how results are validated. A planning guide for laboratory managers.

Hematology Analyser supply near you

Delivery, installation and training across Malaysia from Batu Caves, Kota Kinabalu and Kuching.

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Frequently asked questions

Does a GP clinic need to verify its haematology analyser?
It is good practice. A simple version — precision with controls, a comparison of patient samples with an outside lab and a check of low platelet counts — catches most problems before results reach patients.
How many patient samples are needed for a method comparison?
Protocols commonly use about 40 or more samples spread across the reportable range. Your plan should state the number and why.
How is carryover calculated?
Run a high sample three times and a low sample three times. Carryover (%) = (L1 − L3) ÷ (H3 − L3) × 100, compared with the maker’s claim.
Does a refurbished analyser need verification?
Yes — arguably more than a new one, because its performance after refurbishment is not covered by the original validation.

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