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Also called: Haematology reagents, Diluent, lyse, cleaner, FBC machine reagents

Hematology Analyzer Reagents: What They Do and How to Store Them

Reagents are the largest recurring cost of an FBC machine and a common source of QC problems. Here is how to choose, store and use them.

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What each reagent does

ReagentJobUsed on
DiluentDilutes the sample and carries cells through the counting aperture; also rinses the fluid path3-part and 5-part
LyseBreaks open red cells so white cells can be counted and haemoglobin measured3-part and 5-part (5-part often uses more than one)
CleanerRemoves protein deposits from the aperture and tubing3-part and 5-part
Stain or fluorescent dyeMarks white cells for the optical differential5-part, depending on the model
Control blood and calibratorNot reagents strictly, but recurring consumables for QC and calibration3-part and 5-part

Storage and stability

  • Store at the temperature on the label, out of direct sun and away from heat sources.
  • Note two limits: the expiry date of the unopened pack and the opened (on-board) stability.
  • Write the opening date on every container and use the oldest stock first.
  • Do not top up or combine part-used containers.
  • Control blood is usually kept refrigerated and has a short opened life — follow its insert exactly.
  • Run controls after every reagent lot change and record the lot number.

Closed vs open reagent systems

Closed system

The analyser is designed for the maker’s own reagents, sometimes identified by barcode or tag. Performance is predictable, but you have a single source for pricing and supply.

Open system

Third-party reagents may be used. They can cost less, but must be validated on your analyser, may affect warranty, and must themselves be MDA-registered.

What to ask

Which reagents are validated for the model, whether others void the warranty, and how long reagent prices are fixed.

Planning reagent supply

  • Estimate use from patient samples plus start-up, shutdown, background checks and controls.
  • Match pack sizes to opened stability at your real daily volume.
  • Keep a buffer for dengue-season peaks and agree order lead times with the supplier.
  • Ask whether deliveries can come from a single lot to reduce QC shifts.

Frequently asked questions

Can I use a different brand of diluent on my analyser?
Only if the analyser maker or supplier confirms it is validated for your model. Unvalidated reagents can shift results and may affect warranty and support.
Why did my QC shift after opening a new reagent box?
A new reagent lot can move results slightly. Run controls after every lot change, record the lot number and contact the supplier if the shift persists.
Are haematology reagents regulated in Malaysia?
Yes. Reagents for a haematology analyser are IVD medical devices and need MDA registration, just like the analyser itself.

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