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Sysmex XW-100: What It Is and Whether It Fits a Malaysian Clinic

A compact 3-part analyser built for US physician offices without laboratory staff. What it measures, what it is not for, and what to check before assuming you can buy one here.

Also called Sysmex XW-100, XW 100 hematology analyzer, CLIA-waived CBC analyzer

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What the XW-100 is

The XW-100 from Sysmex America is a compact automated haematology analyser. It counts and sizes cells by impedance (direct current with hydrodynamic focusing) and measures haemoglobin photometrically with a cyanide-free method. The US Food and Drug Administration first cleared it in 2015 for point-of-care use and, on 6 November 2017, granted clearance and a CLIA waiver for a version that staff without laboratory training can run in US physicians’ offices and clinics. Sysmex describes it as the first FDA-cleared, CLIA-waived CBC analyser. This page is a neutral guide and does not mean we stock it.

Key facts

XW-100 for CLIA-waived use
Differential3-part: lymphocytes, neutrophils and “other WBC”
Reported parameters12: WBC, RBC, HGB, HCT, MCV, PLT, and LYM, NEUT and Other WBC as % and absolute counts
SampleVenous whole blood in K2 or K3 EDTA; about 15 µL aspirated from a tube holding about 1 mL
SpeedAbout 3 minutes to a result; up to 20 samples an hour
ReagentsTwo: a lyse (XW Pack L) and a diluent (XW Pack D)
CalibrationFactory-calibrated; the operator never calibrates it
Quality controlControl material run every 8 hours, judged by the software rather than the operator
SizeAbout 19 cm wide, 46 cm deep and 35 cm high; about 17 kg

Built for operators who do not interpret results

Printout, not screen

Results are not shown on the analyser’s screen. It prints the patient ID, date of birth, results and flags for the doctor, which cuts the chance of reading out the wrong patient’s result.

Automatic repeat

When a result falls outside the reference range, the analyser asks for a repeat run. If the repeat agrees, the result prints with a High or Low flag; if not, the value is suppressed as “****” with an alert.

Further testing

When it detects a sample abnormality, the printout reads “RECOMMEND FURTHER TESTING” — the sample should go to a laboratory.

QC failures

In the US set-up, two failed QC runs in a row mean calling Sysmex support, and a replacement analyser is sent while the original goes back for service.

What it is not for

Its FDA intended use rules out several groups a Malaysian clinic sees every week, and its short parameter list leaves out some indices local practice relies on.

  • Diagnosing or monitoring patients with primary or secondary chronic blood disorders.
  • Oncology patients and critically ill patients.
  • Children under 2 years old.
  • Capillary (finger-prick) samples — it is cleared for venous EDTA blood only.
  • A 5-part differential: eosinophils, monocytes and basophils are not reported separately.
  • Thalassaemia screening: MCH is not among the 12 reported parameters, yet an MCH below 27 pg is the screening cut-off used in Malaysia.

Read next Thalassaemia screening on the FBC3-part vs 5-part analysers

Can you buy an XW-100 in Malaysia?

As of October 2026 every source we found on the XW-100 came from Sysmex America and the US market, and we could not confirm an MDA registration for it; Sysmex’s US page itself notes that not all products are registered or sold in every market. The CLIA waiver is a US status with no standing here: in Malaysia every analyser must be registered with the MDA, whoever operates it.

  • If you are offered an XW-100, ask for the MDA registration numbers of the analyser, both reagents and its control material, and check them before you pay.
  • Ask who supplies its reagents and controls in Malaysia and who services it. A unit bought for the US market may have neither here.
  • Compare it on cost per reportable test with compact 3-part analysers that are registered and supported locally.

Read next Checking MDA registrationOther Sysmex analysers

Related guides

Sysmex Hematology Analyzer: XN, XP and What to CheckA neutral look at Sysmex’s haematology families — from compact clinic analysers to laboratory systems — and how to compare them fairly.3-Part Haematology Analyser for Clinics: Reagents and Daily RoutineWhat it is like to own a compact 3-part analyser — the reagents it uses, the daily routine and the habits that keep results and costs under control.Point of Care Blood Analyser Options vs a Full FBC AnalyserSmall finger-prick analysers answer one question quickly; a haematology analyser answers many. Here is how to tell which your clinic needs.

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Frequently asked questions

Is the Sysmex XW-100 a 5-part analyser?
No. It reports a 3-part differential — lymphocytes, neutrophils and “other WBC” — as percentages and absolute counts, out of 12 parameters in total.
What does CLIA-waived mean?
It is a US regulatory category for tests simple enough, and with a low enough risk of error, to be run at sites without full laboratory certification. It has no legal effect in Malaysia, where every analyser needs MDA registration.
Can the XW-100 run finger-prick samples?
No. Its FDA clearance covers venous whole blood collected in K2 or K3 EDTA tubes, with about 15 µL aspirated per test.
Is the XW-100 sold in Malaysia?
We could not confirm that it is marketed or registered here as of October 2026. Ask any seller for its MDA registration number and check it, and note that this guide does not mean we stock it.

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