A Hematological Control Product for Automated Blood Cell Analyzer

Transcription

A Hematological Control Product for Automated Blood Cell Analyzer
J. Med. Tech. Assoc. Thailand, Vol. 38 No. 1, April 2010
Original Article
A Hematological Control Product for Automated
Blood Cell Analyzer
Mayuree Chuntho, Surapon Tangvarasittichai
and Orathai Tangvarasittichai
Department of Medical Technology, Faculty of Allied Health Sciences, Naresuan University,
Phitsanulok 65000, Thailand
Abstract
In-house hematological control products for automated blood cell analyzer were
prepared from citrate-phosphate-dextrose (CPD) fresh whole blood from healthy donors that
had been already screened infectious marker. These whole bloods were removed plasma then
added with additive solution. After fixed with the mixture of formaldehyde and glutaraldehyde,
they were divided into three different values; normal, high and low value. The control products
were measured 14 hematological parameters by using Sysmex XT 1800i automatic blood cell
counter for 6 weeks for evaluated accuracy, precision and stability of control products by
using percentage of coefficient variation (CV).
The results of preparing 3 level value of hematologic control materials of WBC count,
RBC count, Hb, Hct, MCV, MCH, MCHC, platelet count, RDW, % neutrophil, % lymphocyte,
% monocyte, % eosinophil and % basophil by using fresh whole blood donors illustrated that
the percentages CV of high value control material of hematologic parameters were 8.82, 1.06,
1.22, 4.23, 4.8, 0.76, 4.76, 6.28, 4.89, 5.07, 10.11, 27.1 and 13.91, respectively. The percentages
CV of normal value control material were 4.73, 0.85, 1.29, 4.05, 3.53, 0.84, 3.82, 9.84, 4.37,
5.20, 8.23, 10.3 and 6.33, respectively. Including the percentages CV of low value control
material were 3.0, 1.47, 3.58, 4.33, 3.86, 2.43, 4.62, 7.75, 2.88, 3.11, 5.69, 9.7 and 11.37,
respectively. These results indicated that the percentages CV was less than the accepted value
of Sysmex XT 1800i that WBC count and platelet count were less than 10, RBC count, Hb,
Hct, MCV, MCH, MCHC and RDW were less than 5, while % neutrophil, % lymphocyte,
% eosinophil were less than 15 and % monocyte was less than 40.
This study showed that in-house hematological control products was suitable for internal
quality control material at least for 5 weeks without any significant change from the original
(P > 0.05), except WBC count, Hct, % monocyte in the high value control, Hct, MCV,
MCHC, % monocyte in normal value control and Hct, MCV, MCHC, RDW, % eosinophil
in low value control.
Keywords: hematological control product, automated blood cell analyzer
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‚¥¬°“√µ√÷߇´≈≈å¥â«¬πÈ”¬“º ¡√–À«à“ßøÕ√å¡“≈¥’‰Œ¥å (formaldehyde) ·≈–°≈Ÿµ“√“≈¥’‰Œ¥å (glutaraldehyde) µ—«Õ¬à“ß∂Ÿ°‡µ√’¬¡‡ªìπ “√§«∫§ÿ¡§ÿ≥¿“æ 3 √–¥—∫§◊Õ√–¥—∫ª°µ‘ Ÿß°«à“ª°µ‘·≈–µË”°«à“ª°µ‘
µàÕ®“°π—Èπ®÷ß𔉪µ√«®«—¥æ“√“¡‘‡µÕ√å 14 ™π‘¥§◊Õ WBC count, RBC count, Hb, Hct, MCV,
MCH, MCHC, platelet count, RDW, % neutrophil, % lymphocyte, % monocyte, %
eosinophil ·≈– % basophil ‚¥¬„™â‡§√◊ËÕßπ—∫‡¡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘ Sysmex XT 1800i ‡ªìπ‡«≈“ 6
—ª¥“Àå ‚¥¬»÷°…“§«“¡∂Ÿ°µâÕß ·¡à𬔷≈–§«“¡§ß∑π¢Õß “√§«∫§ÿ¡§ÿ≥¿“殓°°“√„™â‡ªÕ√凴Áπµå
—¡ª√– ‘∑∏‘ϧ«“¡·ª√ª√«π (%CV) æ∫«à“§à“‡ªÕ√凴Áπµå —¡ª√– ‘∑∏‘ϧ«“¡·ª√ª√«π (%CV)
¢Õßµ—«Õ¬à“ߧ«∫§ÿ¡§ÿ≥¿“æ∑’Ë¡’√–¥—∫ Ÿß°«à“ª°µ‘‡∑à“°—∫ 8.82, 1.06, 1.22, 4.23, 4.8, 0.76, 4.76, 6.28,
4.89, 5.07, 10.11, 27.1 ·≈– 13.91 µ“¡≈”¥—∫ % CV ¢Õßµ—«Õ¬à“ߧ«∫§ÿ¡§ÿ≥¿“æ√–¥—∫ª°µ‘‡∑à“°—∫
4.73, 0.85, 1.29, 4.05, 3.53, 0.84, 3.82, 9.84, 4.37, 5.2, 8.23, 10.3 ·≈– 6.33 µ“¡≈”¥—∫
à«π % CV ¢Õßµ—«Õ¬à“ߧ«∫§ÿ¡§ÿ≥¿“æ∑’Ë√–¥—∫µË”°«à“ª°µ‘‡∑à“°—∫ 3.0, 1.47, 3.58, 4.33, 3.86, 2.43,
4.62, 7.75, 2.88, 3.11, 5.69, 9.7 ·≈– 11.37 µ“¡≈”¥—∫ ‚¥¬∑’Ë§à“ % CV ®“°°“√∑¥ Õ∫‡À≈à“π’È¡’
§à“πâÕ¬°«à“§à“ % CV ∑’ˇ§√◊ËÕßπ—∫‡¡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘ Sysmex XT 1800i °”Àπ¥™à«ß§à“∑’ˬա√—∫‰¥â
§◊Õ WBC count ·≈– platelet count πâÕ¬°«à“ 10 %, RBC count, Hb, Hct, MCV, MCH,
MCHC ·≈– RDW πâÕ¬°«à“ 5% à«π % neutrophil, % lymphocyte, % eosinophil ·≈–
% basophil πâÕ¬°«à“ 15 % ·≈– % monocyte πâÕ¬°«à“ 40 % ®“°º≈°“√»÷°…“π’È· ¥ß„Àâ‡ÀÁπ«à“
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π—¬ ”§—≠ (P > 0.05) ¬°‡«âπ§à“ WBC count, Hct ·≈–% monocyte ∑’Ë√–¥—∫ Ÿß°«à“ª°µ‘ §à“ Hct,
MCV, MCHC, % monocyte ∑’Ë√–¥—∫ª°µ‘·≈–§à“ Hct, MCV, MCHC, RDW, % eosinophil
∑’√Ë –¥—∫µË”°«à“ª°µ‘
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Count, CBC) °—πÕ¬à“ß·æ√àÀ≈“¬ ‡π◊ËÕß®“° “¡“√∂
µ√«®«‘‡§√“–Àåµ—«Õ¬à“߉¥â‡ªìπ®”π«π¡“° ¡’∑—Èߧ«“¡
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µâπ∑ÿπ§à“„™â®à“¬„π°“√µ√«®«‘‡§√“–Àå CBC ¡’§à“ Ÿß
‰¥â¡’ºŸâ»÷°…“§«“¡§ß∑π¢Õß “√§«∫§ÿ¡§ÿ≥¿“æ∑’Ë
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º ¡°— π„π — ¥ à « πµà “ ßÊ °— π(2) ´÷Ëß«‘∏’°“√‡µ√’¬¡
¥— ß °≈à “ « “¡“√∂µ√«®«— ¥‰¥â„π‡™‘ßª√‘¡“≥ ·µà‰¡à
“¡“√∂µ√«®«—¥‡™‘ߧÿ≥¿“懙àπ°“√µ√«®π—∫·¬°
™π‘¥‡¡Á¥‡≈◊Õ¥¢“«
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‡≈◊Õ¥§√∫ à«π ¥ (fresh whole blood) ¢Õߧπ
„À≥⠓√§«∫§ÿ¡§ÿ≥¿“æ∑’Ë¡’√“§“∂Ÿ°·≈–¡’¢—ÈπµÕπ
°“√‡µ√’¬¡∑’ˉ¡à¬ÿà߬“° ‡æ◊ËÕ„™â ”À√— ∫ °“√§«∫§ÿ ¡
3069
§ÿ≥¿“æ°“√π—∫‡¡Á¥‡≈◊Õ¥·≈–π—∫·¬°™π‘¥‡¡Á¥‡≈◊Õ¥
¢“«¢Õ߇§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘ Sysmex
XT 1800i
«— ¥ÿ ·≈–«‘∏’°“√
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫
‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘ ‡µ√’¬¡¢÷Èπ‚¥¬°“√
„™â‡≈◊Õ¥ ¥§√∫ à«π (fresh whole blood) ®“°
‡≈◊Õ¥ºŸâ∫√‘®“§‚≈À‘µ∑’Ë¡’§«“¡‡¢â¡¢âπ¢Õ߇≈◊Õ¥Õ¬à“ß
‡æ’¬ßæÕ ∑’˺à“π°“√µ√«®§—¥°√Õß‚√§µ‘¥‡™◊ÈÕ „ à “√
°—π‡≈◊Õ¥·¢Áßµ—«™π‘¥ Citrate-phosphate-dextrose
(CPD)(3) „πÕ—µ√“ à«π√–À«à“߇≈◊Õ¥§√∫ à«πµàÕ CPD
§◊Õ 10 : 1.4 ml π”‡≈◊Õ¥‰ªªíòπÀπ—° 3,000- 4,000
rpm π“π 15 π“∑’ ¥Ÿ¥æ≈“ ¡“∑‘Èß(4) π” à«π¢Õß
‡¡Á¥‡≈◊Õ¥Õ—¥·πàπ¡“‡µ‘¡ Additive solution (AS)(5)
„πÕ—µ√“ à«π√–À«à“߇¡Á¥‡≈◊Õ¥Õ—¥·πàπµàÕ AS §◊Õ
10:3.5 ml √—°…“ ¿“懴≈≈å‚¥¬°“√µ√÷߇´≈≈å¥â«¬
πÈ”¬“º ¡√–À«à“ßøÕ√å¡“≈¥’‰Œ¥å (formaldehyde)
3 -20% ·≈–°≈Ÿµ“√“≈¥’‰Œ¥å (glutaraldehyde) 0.01
-1.0%(6) ∑”°“√‡µ√’¬¡µ—«Õ¬à“ß “√§«∫§ÿ¡§ÿ≥¿“æ
∑—Èß√–¥—∫ª°µ‘ Ÿß°«à“ª°µ‘·≈–µË”°«à“ª°µ‘ ‚¥¬
‡µ√’¬¡µ—«Õ¬à“ß≈– 3.5 ml. „ à„πÀ≈Õ¥∑¥≈Õ߇°Á∫
√—°…“‰«â∑’ËÕÿ≥À¿Ÿ¡‘ 4 - 8 Õß»“‡´≈‡´’¬ ·≈â«π”¡“
»÷°…“·∫∫‡ªî¥„™â´È” (‡≈◊Õ¥„πÀ≈Õ¥π”¡“∑¥ Õ∫´È”)
‚¥¬π”µ—«Õ¬à“ß¡“∑¥ Õ∫∑ÿ°«—π‡ªìπ‡«≈“ 6 —ª¥“Àå
»÷°…“§«“¡§ß∑π¢Õ߇≈◊Õ¥‚¥¬°“√„™â‡§√◊ËÕßπ—∫‡¡Á¥
‡≈◊ Õ ¥Õ— µ‚π¡— µ‘ Sysmex XT 1800i «— ¥ °“√
‡ª≈’ˬπ·ª≈ߢÕߧà“æ“√“¡‘‡µÕ√å 14 ™π‘¥ ‰¥â·°à °“√
π—∫‡¡Á¥‡≈◊Õ¥¢“« (WBC count), °“√π—∫‡¡Á¥‡≈◊Õ¥
·¥ß (RBC count), Œ’‚¡‚°≈∫‘π (Hemoglobin,
Hb), ª√‘¡“µ√‡¡Á¥‡≈◊Õ¥·¥ßÕ—¥·πàπ (Hematocrit,
Hct), ª√‘¡“µ√‡©≈’ˬ¢Õ߇¡Á¥‡≈◊Õ¥·¥ß (MCV),
ª√‘¡“≥‡©≈’¬Ë ¢Õߌ’‚¡‚°≈∫‘π„π‡¡Á¥‡≈◊Õ¥·¥ß (MCH),
§«“¡‡¢â ¡ ¢â 𠇩≈’Ë ¬ ¢Õߌ’ ‚ ¡‚°≈∫‘ π„π‡¡Á ¥ ‡≈◊ Õ ¥·¥ß
(MCHC), platelet count, RDW, %neutrophil,
3070
%lymphocyte, %monocyte, %eosinophil ·≈–
%basophil ∫—π∑÷°º≈§à“¢Õßæ“√“¡‘‡µÕ√å 14 ™π‘¥
∑’‰Ë ¥â®“°‡§√◊ÕË ß π”¡“§”π«≥À“§à“‡©≈’¬Ë (mean), à«π
‡∫’ˬ߇∫π¡“µ√∞“π (standard deviation, SD) ·≈–
—¡ª√– ‘∑∏‘ϧ«“¡·ª√ª√«π (coefficient of variation, CV) π”§à“ %CV ∑’ˉ¥â¡“‡∑’¬∫°—∫§à“ %CV
¢Õß∑’Ë ¬ Õ¡√— ∫‰¥â ¢ Õ߇§√◊Ë Õ ßπ— ∫ ‡¡Á ¥ ‡≈◊ Õ ¥Õ— µ‚π¡— µ‘
Sysmex XT 1800i(7) ·≈–∑¥ Õ∫§«“¡·µ°µà“ß
¢Õß§à “ ∑’Ë «— ¥‰¥â‚¥¬„™â One-way ANOVA ‚¥¬
‡∑’¬∫°—∫§à“™à«ß°“√‡ª≈’ˬπ·ª≈ß (±2SD) ¢Õß
control cell ∑’ˬա√—∫‰¥â®“°¢Õß∫√‘…—∑‡¡¥‘∑Õª ‚¥¬
°“√‡ª√’¬∫‡∑’¬∫º≈°“√∑¥ Õ∫°—∫º≈¢Õß —ª¥“Àå·√°
º≈°“√«‘®¬—
®“°°“√»÷ ° …“ “√§«∫§ÿ ¡ §ÿ ≥ ¿“æ∑“ß
‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
∑’Ë ‡ µ√’ ¬ ¡¢÷È π ®“°°“√„™â‡≈◊Õ¥ ¥§√∫ à«π ∑’Ë¡’°“√
√— ° …“ ¿“懴≈≈å ‚ ¥¬°“√µ√÷ ß ‡´≈≈å ¥â « ¬πÈ” ¬“º ¡
√–À«à“ßøÕ√å¡“≈¥’‰Œ¥å ·≈–°≈Ÿµ“√“≈¥’‰Œ¥å ∑—Èß√–¥—∫
ª°µ‘ Ÿß°«à“ª°µ‘·≈–µË”°«à“ª°µ‘ π”§à“ %CV ∑’ˉ¥â
¡“‡∑’¬∫°—∫§à“ %CV ∑’ˬա√—∫‰¥â¢Õ߇§√◊ËÕßπ—∫‡¡Á¥
‡≈◊Õ¥Õ—µ‚π¡—µ‘ Sysmex XT 1800i æ∫«à“% CV
¡¬ÿ√’ ®—π∑√å ‚∑ ·≈–§≥–
¢ÕßWBC, RBC, Hb, HCT, MCV, MCH,
MCHC, PLT, RDW, %N, %L, %M, %E, %B
¢Õßµ— « Õ¬à “ ߧ«∫§ÿ ¡ §ÿ ≥ ¿“æ∑’Ë √ –¥— ∫ Ÿ ß °«à “ ª°µ‘ ∑’Ë
¬Õ¡√—∫‰¥â‡∑à“°—∫ 8.82, 1.06, 1.22, 4.23, 4.8, 0.76,
4.76, 6.28, 4.89, 5.07, 10.11, 27.1 ·≈– 13.91
(µ“√“ß∑’Ë 1) %CV ¢Õßµ—«Õ¬à“ߧ«∫§ÿ¡§ÿ≥¿“æ
√–¥—∫ª°µ‘∑¬’Ë Õ¡√—∫‰¥â‡∑à“°—∫ 4.73, 0.85, 1.29, 4.05,
3.53, 0.84, 3.82, 9.84, 4.37, 5.20, 8.23, 10.3
·≈– 6.33 (µ“√“ß∑’Ë 2) à«π %CV ¢Õßµ—«Õ¬à“ß
§«∫§ÿ¡§ÿ≥¿“æ∑’√Ë –¥—∫µË”°«à“ª°µ‘∑¬’Ë Õ¡√—∫‰¥â‡∑à“°—∫
3.0, 1.47, 3.58, 4.33, 3.86, 2.43, 4.62, 7.75,
2.88, 3.11, 5.69, 9.7 ·≈– 11.37 (µ“√“ß∑’Ë 3)
æ∫«à“æ“√“¡‘‡µÕ√å à«π„À≠à¢Õß “√§«∫§ÿ¡
§ÿ≥¿“æ∑—Èß 3 √–¥—∫ ¡’·π«‚πâ¡¢Õß§à“ %CV §ß∑’Ë
Õ¬Ÿ„à π™à«ß∑’¬Ë Õ¡√—∫‰¥âµ¥‘ µàÕ°—π‡ªìπ√–¬–‡«≈“ª√–¡“≥
5 —ª¥“Àå ¬°‡«âπ§à“ WBC count (2 —ª¥“Àå), Hct
(3 —ª¥“Àå) % monocyte (1 —ª¥“Àå) ∑’Ë√–¥—∫ Ÿß
°«à“ª°µ‘ §à“ Hct (1 —ª¥“Àå), MCV ·≈– MCHC
(2 —ª¥“Àå) % monocyte (2 —ª¥“Àå) ∑’Ë√–¥—∫ª°µ‘
·≈–§à“ Hct, MCV (2 —ª¥“Àå), MCHC (3 —ª¥“Àå)
·≈– RDW (1 — ª ¥“Àå ) ∑’Ë √ –¥— ∫ µË” °«à “ ª°µ‘
(µ“√“ß∑’Ë 1-3 ·≈–√Ÿª∑’Ë 1 - 3)
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
3071
Table 1 The between run precision value of %CV in high control material tested every
day for 6 weeks
Parameter
Assay
(Day 0)
% CV
Accepted
Range Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
WBC
7.12/cumm
< 10
5.44
8.82
16.64*
23.76*
29.62*
38.57*
RBC
6.52/cumm
<5
0.6
0.72
0.89
0.94
0.95
1.06
Hb
17.5 gm%
<5
0.3
0.5
0.79
0.87
1.1
1.22
HCT
53.3%
<5
1.72
3.41
4.23
5.13*
5.56*
6.11*
MCV
81.7 fl
<5
1.38
2.93
3.5
4.36
4.8
5.28*
MCH
26.8 pg
<5
0.78
0.76
0.74
0.71
0.8
0.76
MCHC
32.8%
<5
1.71
3.3
3.81
4.51
4.76
5.2*
PLT
131/cumm
< 10
5.53
5.58
6.14
6.31
6.02
6.28
RDW-CV
15.6%
<5
2.03
4.42
4.35
4.12
4.29
4.89
N
53.6%
< 15
2.84
3.02
2.7
3.73
3.94
5.07
L
29.5%
< 15
5.54
4.25
4.02
5.4
7.7
10.11
M
7.9%
< 40
27.1
51.96*
61.12*
68.95*
67.48*
71.89*
E
8.3%
< 15
15.8
13.16
11.72
12.33
11.88
13.91
B
0.7 %
< 15
35.95
38.74
51.2
63.88
67.62
79.57
* P-value < 0.05 by one way ANOVA
¡¬ÿ√’ ®—π∑√å ‚∑ ·≈–§≥–
3072
Table 2 The between run precision value of %CV in normal control material tested
every day for 6 weeks
Parameter
Assay
(Day 0)
% CV
Accepted
Range Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
WBC
5.28/cumm
< 10
2.13
2.57
3.23
3.31
4.01
4.73
RBC
4.8/cumm
<5
0.77
0.58
0.68
0.82
0.81
0.85
Hb
13.0 gm%
<5
0.37
0.59
0.71
0.96
1.15
1.29
HCT
37.9%
<5
4.05
5.39*
6.05*
6.73*
6.93*
6.92*
MCV
79.0 fl
<5
3.53
5.11
5.65*
6.15*
6.33*
6.28*
MCH
27.1 pg
< 5
0.55
0.56
0.64
0.68
0.79
0.84
MCHC
34.3%
<5
3.82
5.11
5.69*
6.13*
6.21*
6.15*
PLT
100/cumm
< 10
3.34
6.41
8.09
7.57
9.84
11.45*
RDW-CV
14.2%
<5
5.01
4.57
4.5
4.22
4.37
7.12*
N
58.3%
< 15
5.85
5.25
5.26
5.24
5.27
5.20
L
28.8%
< 15
10.74
10.01
9.57
8.99
8.56
8.23
M
7.4%
< 40
5.2
10.3
43.23*
49.26*
53.48*
65.01*
E
4.7%
< 15
8.0
6.23
6.45
6.55
6.33
B
0.8%
< 15
51.23
61.19
57.27
60.64
54.42
* P-value < 0.05 by one way ANOVA
6.71
53.1
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
3073
Table 3 The between run precision value of %CV in low control material tested every
day for 6 weeks
Parameter
Assay
(Day 0)
%CV
Accepted
Range Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
WBC
2.93/cumm
< 10
3.73
3.26
3.15
3.08
2.93
3
RBC
2.63/cumm
<5
0.96
0.86
0.94
1.08
1.07
1.47
Hb
7.1 gm%
<5
1.53
1.62
1.76
2.16
2.67
3.58
HCT
21.0%
<5
1.67
4.33
6.01*
8.77*
10.37*
12.99*
MCV
79.8 fl
<5
1.14
3.86
5.4*
7.89*
9.54*
11.63*
MCH
27.0 pg
< 5
1.51
1.49
1.45
1.57
2.06
2.43
MCHC
33.8 %
<5
1.26
3.37
4.62
6.55*
7.53*
9.06*
PLT
44/cumm
< 10
8.79
8.05
7.22
7.75
10.11*
14.31*
RDW-CV
13.5 %
<5
2.88
6.23*
8.46*
11.15*
12.09*
12.53*
N
56.3 %
< 15
3.4
3.59
3.34
3.1
3.02
3.11
L
29.4 %
< 15
5.48
5.92
6.04
5.6
5.62
5.69
M
7.8 %
< 40
7.77
8.95
10
10.03
9.71
9.7
E
4.8 %
< 15
11.37
22.01*
37.78*
49.67*
58.73*
67.06*
B
1.7 %
< 15
52.71
61.62
56.37
52.92
50.16
47.84
* P-value < 0.05 by one way ANOVA
3074
¡¬ÿ√’ ®—π∑√å ‚∑ ·≈–§≥–
Fig. 1 Stability testing of high control material during the 6-week period
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
Fig. 2 Stability testing of normal control material during the 6-week period
3075
3076
¡¬ÿ√’ ®—π∑√å ‚∑ ·≈–§≥–
Fig. 3 Stability testing of low control material during the 6-week period
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
√ÿª«‘®“√≥å
“√§«∫§ÿ¡§ÿ≥¿“æ (quality control
material) ∑“ß‚≈À‘µ«‘∑¬“ ‡ªìπ à«π∑’Ë ”§—≠„π°“√
¥”‡π‘πß“π§«∫§ÿ¡§ÿ≥¿“æ ‡æ◊ËÕ„À⇰‘¥§«“¡¡—Ëπ„®«à“
º≈°“√µ√«®«‘‡§√“–Àå complete blood count, CBC
∑’ˉ¥â¡’§à“„°≈⇧’¬ß°—∫§«“¡‡ªìπ®√‘ß¡“°∑’Ë ÿ¥ ªí®®ÿ∫—π
°“√‡µ√’¬¡ “√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“¢÷Èπ„™â
‡Õß∑”‰¥â§àÕπ¢â“߬“° ‡π◊ËÕß®“°µâÕß„™â‡≈◊Õ¥¢Õߧπ
·≈–„™â‡´≈≈凡Á¥‡≈◊Õ¥∑’ˬ—ß¡’™’«‘µ „™â«‘∏’‡µ√’¬¡·∫∫
·¬° à«π§◊Õ‡µ√’¬¡‡¡Á¥‡≈◊Õ¥·¥ß·≈–‡°≈Á¥‡≈◊Õ¥®“°
‡≈◊Õ¥§π ‡µ√’¬¡‡¡Á¥‡≈◊Õ¥¢“«ª≈Õ¡®“°‡≈◊Õ¥‰°à∑’Ë¡’
𑫇§≈’¬ ·≈–¢π“¥‡∑à“°—∫‡¡Á¥‡≈◊Õ¥¢“«¢Õߧπ π”
¡“º ¡°—π„π —¥ à«πµà“ßÊ °—π ´÷Ëß°“√‡µ√’¬¡¥â«¬«‘∏’
¥—ß°≈à“«°Á “¡“√∂µ√«®«—¥‰¥â·µà„π‡™‘ßª√‘¡“≥ ¬—߉¡à
“¡“√∂µ√«®π—∫·¬°™π‘¥‡¡Á¥‡≈◊Õ¥¢“«‰¥â ¥â«¬‡Àµÿ
π’È Àâ Õ ßªØ‘ ∫— µ‘ ° “√ à « π„À≠à ®÷ ß ¬— ß ®”‡ªì π µâ Õ ß´◊È Õ “√
§«∫§ÿ¡§ÿ≥¿“æ∑’πË ”‡¢â“®“°µà“ߪ√–‡∑» ∑’¡Ë √’ “§“·æß
∑”„Àâµâπ∑ÿπ§à“„™â®à“¬„π°“√µ√«®«‘‡§√“–Àå CBC ¡’
§à“ Ÿß
„π°“√»÷ ° …“§«“¡§ß∑π¢Õß “√§«∫§ÿ ¡
§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“∑’‡Ë µ√’¬¡®“°‡≈◊Õ¥ ¥§√∫ à«π
(fresh whole blood ) ¢Õ߇≈◊Õ¥ºŸâ∫√‘®“§‚≈À‘µ∑’Ë
„ à “√°—π‡≈◊Õ¥·¢Áßµ—«™π‘¥ Citrate-phosphatedextrose (CPD) ¥Ÿ¥æ≈“ ¡“∑‘Èß·≈â«∑¥·∑π à«π
¥—ß°≈à“«¥â«¬ Additive solution (AS) ∑’˪√–°Õ∫
¥â«¬ dextrose ·≈– adenine ‡æ◊ËÕ‡ªìπ·À≈àߢÕß
πÈ”µ“≈°≈Ÿ‚§ ·≈–‡ªìπ “√µ—ßÈ µâπ ”À√—∫°“√ —߇§√“–Àå
ATP „Àâ ‡ ´≈≈å ∑”°“√µ√÷ ß ‡´≈≈å ¥â « ¬πÈ” ¬“º ¡
√–À«à“ßøÕ√å¡“≈¥’‰Œ¥å (formaldehyde) ·≈–°≈Ÿµ“√“≈¥’ ‰ Œ¥å (glutaraldehyde) ‡µ√’ ¬ ¡µ— « Õ¬à “ ß
“√§«∫§ÿ¡§ÿ≥¿“æ„À⇪ìπ√–¥—∫ª°µ‘ Ÿß°«à“ª°µ‘
·≈–µË” °«à “ ª°µ‘ æ∫«à “„™â § «“¡‡¢â ¡ ¢â π ¢ÕßπÈ” ¬“
øÕ√å¡“≈¥’‰Œ¥å„π°“√µ√÷߇´≈≈å¢Õß “√§«∫§ÿ¡§ÿ≥¿“æ
∑—Èß 3 √–¥—∫‰¡à‡∑à“°—π √–¥—∫µË”°«à“ª°µ‘®–„™â§«“¡
3077
‡¢â¡¢âπ¢ÕßøÕ√å¡“≈¥’‰Œ¥å Ÿß°«à“√–¥—∫ª°µ‘·≈–√–¥—∫
Ÿß°«à“ª°µ‘ Õ“®‡ªìπº≈®“°°“√∑’πË È”¬“øÕ√å¡“≈¥’‰Œ¥å
∂Ÿ°‡®◊Õ®“ߥ⫬ Additive solution °“√‡°Á∫√—°…“
µ—«Õ¬à“ß “√§«∫§ÿ¡§ÿ≥¿“æ√–À«à“ß°“√∑¥ Õ∫‰«â∑’Ë
Õÿ≥À¿Ÿ¡‘ 4 - 8 Õß»“‡´≈‡´’¬ °Á‡æ◊Ëՙ૬≈¥ glycolytic activity ¢Õ߇´≈≈å ‡π◊ËÕß®“°æ∫«à“Õÿ≥À¿Ÿ¡‘∑’Ë
Ÿß¢÷Èπ®–™à«¬‡√àß°“√‡ª≈’ˬπ·ª≈ߢÕ߇´≈≈å∑”„À⇴≈≈å
‡°‘¥°“√‡ª≈’ˬπ·ª≈߉¥â¡“°(8) ®“°°“√»÷°…“§√—Èßπ’ȇ√“
«‘‡§√“–Àåµ—«Õ¬à“ß·∫∫‡ªî¥„™â´È”‚¥¬π”µ—«Õ¬à“ßÀ≈Õ¥
‡¥‘¡¡“∑¥ Õ∫‡æ◊ËÕµâÕß°“√„Àâ¡’ ¿“«–„°≈⇧’¬ß°—∫
°“√„™âß“π®√‘ß¡“°∑’Ë ÿ¥ ∑”„ÀâµâÕßπ”µ—«Õ¬à“߇¢â“ÕÕ°
µŸâ‡¬Áπ∫àÕ¬Ê Õ“®‡ªìπ‡Àµÿ„À⇴≈≈凰‘¥°“√‡ ◊ËÕ¡ ¿“æ
‰¥â‡√Á«¢÷Èπ ¥—ßπ—ÈπÀ“°¡’°“√‡µ√’¬¡µ—«Õ¬à“ß “√§«∫§ÿ¡
§ÿ≥¿“æ·≈â«·∫àß„ àÀ≈Õ¥ ”À√—∫„™âß“πµàÕ —ª¥“Àå ·≈â«
‡°Á∫∑’ËÕÿ≥À¿Ÿ¡‘ 4 - 8 Õß»“‡´≈‡´’¬ πà“®–∑”„Àâ
‡´≈≈å§ß∑π‰¥âπ“π°«à“ 5 —ª¥“Àå
§à “ æ“√“¡‘ ‡ µÕ√å à « π„À≠à ¢ Õßµ— « Õ¬à “ ß “√
§«∫§ÿ¡§ÿ≥¿“æ∑—Èß 3 √–¥—∫ ¡’ %CV Õ¬Ÿà„π™à«ß∑’Ë
¬Õ¡√—∫‰¥â µ‘¥µàÕ°—π‡ªìπ√–¬–‡«≈“ª√–¡“≥ 5 —ª¥“Àå
¬°‡«âπ§à“ WBC count ∑’Ë√–¥—∫ Ÿß°«à“ª°µ‘¡’ % CV
Õ¬Ÿà„π™à«ß¬Õ¡√—∫‰¥â (P > 0.05) ®π∂÷ß 2 —ª¥“Àå
À≈— ß ®“°π—È π ¡’ · π«‚πâ ¡ ≈¥µË” ≈ß Õ“®‡π◊Ë Õ ß¡“®“°
—¥ à«π¢ÕßπÈ”¬“µ√÷߇´≈≈嬗߉¡à‡À¡“– ¡À√◊Õ‡°‘¥
°“√‡ªî¥Ω“À≈Õ¥µ—«Õ¬à“ß„π°“√µ√«®«‘‡§√“–Àå∫àÕ¬Ê
∑”„À⧫“¡‡¢â¡¢âπ¢Õß “√≈–≈“¬„πÀ≈Õ¥‡ª≈’¬Ë π·ª≈ß
‡´≈≈å®÷߇°‘¥°“√‡ª≈’Ë¬π ¿“æ‰¥â §à“¢Õß Hct ∑—Èß 3
√–¥—∫¡’ % CV Õ¬Ÿ„à π™à«ß¬Õ¡√—∫‰¥â®π∂÷ß 2 - 3 —ª¥“Àå
(P > 0.05) À≈—ß®“°π—Èπ¡’·π«‚π⡇æ‘Ë¡ Ÿß¢÷Èπ °“√
‡ª≈’¬Ë π·ª≈ßπ’‡È °‘¥®“°‡¡◊ÕË ‡«≈“π“π¢÷πÈ ‡´≈≈å®–¡’√–¥—∫
ATP ≈¥≈ß∑”„À⇰‘¥°“√ Ÿ≠‡ ’¬ ¡¥ÿ≈¬å¢Õß Na+
·≈– K+ ¿“¬„π·≈–¿“¬πÕ°‡´≈≈å(9,10) ‚¥¬°“√¢—∫
K+ ÕÕ°·≈–√—∫‡Õ“ Na+ ·≈–πÈ”‡¢â“‡´≈≈å ¡’º≈∑”„Àâ
‡´≈≈凡Á¥‡≈◊Õ¥·¥ß‡°‘¥°“√∫«¡¢÷Èπ §à“ Hct ®÷߇æ‘Ë¡ Ÿß
´÷Ëß¡’º≈∑”„Àâ§à“¢Õß MCV Ÿß¢÷Èπ·≈–§à“ MCHC
3078
≈¥µË”≈ßµ“¡ §à“¢Õß RDW ∑’Ë√–¥—∫µË”°«à“ª°µ‘¡’ %
CVÕ¬Ÿà„π™à«ß∑’ˬա√—∫‰¥â‡æ’¬ß 1 —ª¥“Àå „π¢≥–
√–¥—∫ª°µ‘·≈– Ÿß°«à“ª°µ‘ “¡“√∂¬Õ¡√—∫‰¥â∂÷ß 5
— ª ¥“Àå Õ“®‡π◊Ë Õ ß¡“®“°§«“¡°«â “ ߢÕߧ«“¡
·ª√ª√«π¢Õß§à“ Hct ∑’Ë√–¥—∫µË”°«à“ª°µ‘ (1.6712.99) ¡’§«“¡°«â“ß¡“°°«à“√–¥—∫ª°µ‘ (4.05-6.92)
·≈–√–¥—∫ Ÿß°«à“ª°µ‘ (1.72-6.11) ¥—ßπ—ÈπÀ“°‡√“
“¡“√∂‡æ‘Ë¡æ≈—ßß“π ATP „Àâ·°à‡´≈≈凡Á¥‡≈◊Õ¥·¥ß
‡æ◊Ë Õ„À⇴≈≈å “¡“√∂√—°…“ ¡¥ÿ≈¬å¢Õß√–¥—∫ Na+
·≈– K+ „À⇪ìπª°µ‘°Á®–∑”„À⇴≈≈凡Á¥‡≈◊Õ¥·¥ß
“¡“√∂√—°…“ ¿“æ‰¥â §à“¢Õß Hct MCV, MCHC
·≈– RDW °Á®–§ß∑ππ“π¢÷πÈ §à“¢Õß platelet count
∂÷ß®–¡’ %CV Õ¬Ÿà„π™à«ß¬Õ¡√—∫‰¥â∑—Èß 3 √–¥—∫ ·µà
°Áæ∫«à“¡’°“√·°«àߢÕß§à“ %CV ´÷ËßÕ“®‡°‘¥®“°
∏√√¡™“µ‘¢Õß platelet ∑’ Ë “¡“√∂‡°“–°≈ÿ¡à °—π °“√π”
À≈Õ¥µ—«Õ¬à“ßµ—È߉«â∑’ËÕÿ≥À¿Ÿ¡‘ÀâÕß·≈–º ¡‡≈◊Õ¥„Àâ
¥’°àÕπ°“√µ√«®«‘‡§√“–Àå®–™à«¬≈¥ªí≠À“°“√·°«àß
¢Õß§à“§«“¡·ª√ª√«ππ’ȉ¥â
°“√‡µ√’ ¬ ¡ “√§«∫§ÿ ¡ §ÿ ≥ ¿“æ¥â « ¬«‘ ∏’
¥—ß°≈à“« ¬—ßæ∫«à“ “¡“√∂𔉪„™â‡ªìπµ—«Õ¬à“ß “√
§«∫§ÿ¡§ÿ≥¿“æ¿“¬„π ”À√—∫°“√π—∫·¬°™π‘¥‡¡Á¥
‡≈◊Õ¥¢“«‰¥â ®–‡ÀÁπ‰¥â®“°§à“ %neutrophil, %
lymphocyte ¢Õß∑—Èß 3 √–¥—∫¡’ %CV Õ¬Ÿà„π™à«ß∑’Ë
¬Õ¡√—∫‰¥âµ‘¥µàÕ°—π‡ªìπ√–¬–‡«≈“ª√–¡“≥ 5 —ª¥“Àå
·µà %eosinophil “¡“√∂„™â‰¥â„π√–¥—∫ª°µ‘·≈– Ÿß
√–¥—∫ª°µ‘ ·≈– %monocyte “¡“√∂𔉪„™â‰¥â„π
√–¥—∫µË”°«à“ª°µ‘‡∑à“π—Èπ ∑—Èßπ’ÈÕ“®‡π◊ËÕß¡“®“°‡∑§π‘§
¡¬ÿ√’ ®—π∑√å ‚∑ ·≈–§≥–
°“√‡µ√’¬¡, √–¬–‡«≈“·≈– —¥ à«π¢ÕßπÈ”¬“µ√÷߇´≈≈å
¬—߉¡à‡À¡“– ¡ à«π‡¡Á¥‡≈◊Õ¥¢“«™π‘¥ basophil ∑’Ë
ª°µ‘¡’ª√‘¡“≥‡æ’¬ß‡≈Á°πâÕ¬ ‡¡◊ËÕ¡’°“√‡ª≈’ˬπ·ª≈ß®–
∑”„Àâ¡’§«“¡·ª√ª√«π Ÿß ·≈–§ÿ≥ ¡∫—µ‘∑“ß™’«‡§¡’
¢Õß basophil ∑’Ë “¡“√∂∑πµàÕ¿“«–∑’ˇªìπ°√¥‰¥â¥’
°«à“‡¡Á¥‡≈◊Õ¥¢“«™π‘¥Õ◊Ëπ ∑”„ÀâÕ“®µâÕß√Õ‡«≈“¿“¬
À≈—ß°“√µ√÷߇´≈≈å„À⇴≈≈凪≈’ˬπ·ª≈ß√Ÿª√à“ß®π‡¢â“ Ÿà
¿“æ§ß∑’Ë°àÕπ ´÷Ëß®–π“π°«à“‡¡Á¥‡≈◊Õ¥¢“«™π‘¥Õ◊Ëπ
‡ÀÁπ‰¥â®“° %CV ¢Õß∑—Èß 3 √–¥—∫∑’Ë Ÿß°«à“™à«ß∑’Ë
¬Õ¡√—∫·µà§àÕπ¢â“ߧß∑’˵≈Õ¥‡«≈“ 3 - 6 —ª¥“Àå
®“°°“√»÷°…“„π§√—Èßπ’È √ÿª‰¥â«à“ “√§«∫§ÿ¡
§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ “¡“√∂‡µ√’¬¡‰¥â®“°‡≈◊Õ¥
¥§√∫ à«π¢Õ߇≈◊Õ¥ºŸâ∫√‘®“§‚≈À‘µ∑’Ë„ à “√°—π‡≈◊Õ¥
·¢Áßµ—«™π‘¥ Citrate-phosphate-dextrose (CPD)
∑’Ë ¥Ÿ ¥ æ≈“ ¡“∑‘È ß ·≈â « ∑¥·∑π à « π¥— ß °≈à “ «¥â « ¬
Additive solution (AS) ∑”°“√µ√÷߇´≈≈å¥â«¬
πÈ”¬“º ¡√–À«à“ßøÕ√å¡“≈¥’‰Œ¥å ·≈– °≈Ÿµ“√“≈¥’‰Œ¥å
„π —¥ à«π∑’Ë·µ°µà“ß°—π·≈⫪√—∫„À≥⇪ìπµ—«Õ¬à“ß
“√§«∫§ÿ¡§ÿ≥¿“æ√–¥—∫ª°µ‘ Ÿß°«à“ª°µ‘·≈–µË”
°«à“ª°µ‘ ‚¥¬«‘∏’°“√‡µ√’¬¡¥—ß°≈à“« “¡“√∂∑”‰¥âßà“¬
‡π◊ËÕß®“°«— ¥ÿ·≈–Õÿª°√≥åµà“ßÊ ∑’Ë „ ™â À “‰¥â®“°ß“π
ª√–®”¿“¬„πÀâÕߪؑ∫—µ‘°“√·≈–‚√ß欓∫“≈ ∑”„Àâ
µâπ∑ÿπ„π°“√¥”‡π‘π°“√‰¡à·æß ¢—ÈπµÕπ‰¡à¬ÿà߬“° ®÷ß
“¡“√∂𔉪ª√–¬ÿ°µå„™â°—∫°“√‡µ√’¬¡ “√§«∫§ÿ¡
§ÿ≥¿“æ¿“¬„π ‡æ◊ËÕ„™â„πß“π ”À√—∫°“√µ√«® CBC
‚¥¬‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘ Sysmex XT
1800i
“√§«∫§ÿ¡§ÿ≥¿“æ∑“ß‚≈À‘µ«‘∑¬“ ”À√—∫‡§√◊ËÕß«‘‡§√“–À凡Á¥‡≈◊Õ¥Õ—µ‚π¡—µ‘
°‘µµ‘°√√¡ª√–°“»
¢Õ¢Õ∫§ÿ≥ ”π—°ß“π°Õß∑ÿπ π—∫ πÿπ°“√
«‘®—¬∑ÿπ«‘®—¬¡À“∫—≥±‘µ °«. “¢“«‘∑¬“»“ µ√å·≈–
‡∑§‚π‚≈¬’ ¿“¬„µâ‚§√ß°“√‡™◊ËÕ¡‚¬ß¿“§°“√º≈‘µ°—∫
ß“π«‘®—¬ ∑ÿπ °«. - Õÿµ “À°√√¡ ∑’Ë„Àâ∑ÿπ π—∫ πÿπ
ß∫§à“„™â®“à ¬„π°“√«‘®¬— §√—ßÈ π’È ¢Õ¢Õ∫§ÿ≥ √Õß»“ µ√“®“√¬å ¥√. Õ√∑—¬ µ—ßÈ «√ ‘∑∏‘™¬— ·≈–ºŸ™â «à ¬»“ µ√“®“√¬å
¥√. ÿ√æ≈ µ—Èß«√ ‘∑∏‘™—¬ ¿“§«‘™“‡∑§π‘§°“√·æ∑¬å
§≥– À‡«™»“ µ√å ¡À“«‘∑¬“≈—¬π‡√»«√ ∑’Ë°√ÿ≥“
„Àâ¢âÕ‡ πÕ·π–∑’Ë¡’§ÿ≥§à“ ¢Õ¢Õ∫§ÿ≥ ‡®â“Àπâ“∑’ËÀâÕß
ªØ‘∫—µ‘ ß“π‚≈À‘µ«‘∑¬“ ‚√ß欓∫“≈‡æ™√∫Ÿ√≥å ∑’Ë„Àâ
§«“¡Õπÿ‡§√“–Àå„π°“√»÷°…“§√—Èßπ’È
‡Õ° “√Õâ“ßÕ‘ß
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§«∫§ÿ¡§ÿ≥¿“æ ”À√—∫°“√∑¥ Õ∫‡§√◊ËÕßπ—∫
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