Scribd
Upload
67 views2 pages

Sysmex

The document outlines procedures for evaluating the performance of a blood analyzer, including carrying out measurements in triplicate on high and low concentration samples, assessing precision with multiple runs of normal, low, and high samples for three parameters, comparing results from 40 patient samples tested on two analyzers within 2 hours, verifying the analyzer's linearity using a control sample, and comparing the analyzer's reference intervals against 20 local samples.

Uploaded by

iman zainuddin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
67 views2 pages

Sysmex

The document outlines procedures for evaluating the performance of a blood analyzer, including carrying out measurements in triplicate on high and low concentration samples, assessing precision with multiple runs of normal, low, and high samples for three parameters, comparing results from 40 patient samples tested on two analyzers within 2 hours, verifying the analyzer's linearity using a control sample, and comparing the analyzer's reference intervals against 20 local samples.

Uploaded by

iman zainuddin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
You are on page 1/ 2

Procedure

A Carryover
Measure a high concentration blood sample 3 times, followed by measuring a low
concentration sample 3 times

B Precision
Within Run Precision
2 sample for each category:
* Each sample perform 11x continous run
Normal:
HGB
WBC
PLT
LOW:
HGB (< 7g/dL)
WBC (< 2x10^9/L)
PLT (< 50x10^9/L)
HIGH
HGB (>18g/dL)
WBC (> 50x10^9/L)
PLT (> 600x10^9/L)
Between Run Precision

3 levels of XNL Check


*Perform 4x run per day and continous for 5 days

C Correlation study
40 different patient samples are tested (analyze 8 samples per day)
within 2 hours of each analyzer

WBC (x10^9/L)
<2.0
2.0 – 5.0
5.1 – 11.0
11.1 – 50.0
>50.1

RBC ( x10^12/L)
<3.00
3.00 – 4.00
4.01 – 5.00
5.01 – 6.00
>6.01
Hb (g/dL)
<10.0
10.0 – 12.0
12.1 – 16.0
16.1 – 18.0
18.1

PLT (x10^9/L)
<40
40 - 125
126 -300
301 - 500
500 - 600
>601

D Linerity
use Sysmex Range Check X II

E Reference Interval(verify current reference ranges)


Compare with 20 local reference samples

You might also like