CELL-DYN Sapphire 血液分析仪的CD61免疫学法、光学法、电阻抗法在低值血小板计数中的比较与应用

doi:10.3969/j.issn.1673-8640.2015.03.018

摘要/Abstract

摘要： 目的

评价和比较CELL-DYN Sapphire血液分析仪的3种检测方法在低值血小板(PLT)检测方面的优劣性。

方法

选择基础血液病或肿瘤化疗后引起的PLT低于50×10⁹/L 100例,分别使用电阻抗法、光学法和CD61免疫学法3种方法进行PLT计数,并与显微镜手工法(MPLT)作比较。运用SPSS 19.0和MedCalc V12.7.2.0分析软件对数据进行方差分析、Passing-Bablok回归分析和Bland-Altman偏倚分析。

结果

ANOVA分析显示,电阻抗法、光学法PLT计数与MPLT比较,差异有统计学意义(分别为P=0.00,P=0.002),CD61免疫学法与MPLT差异无统计学意义(P=0.915);OPLT和CD61免疫学法与MPLT的相关性较好(分别为slope 1.0,95%CI为0.95~1.06,r=0.946和slope 1.0,95%CI为0.99~1.01,r=0.998),电阻抗法与MPLT的相关性较差(slope 1.27,95%CI为1.10~1.44,r=0.845)。通过偏差分析,电阻抗法、光学法PLT计数比MPLT检测的数值更高(差异均值分别为6.3、1.3),CD61免疫学法与MPLT检测的数值差异无统计学意义(差异均值=-0.02)。

结论

在低值PLT的检测中,电阻抗法与MPLT存在明显的统计学差异,相关性差,且结果有明显偏差(偏高);光学法与MPLT存在统计学差异,结果仍存在少量偏差(偏高),但相关性较好;而CD61免疫学法与MPLT均值无明显差异,相关性好,结果无明显偏差。所以,当临床出现低值病例时,推荐使用CD61免疫学法PLT进行计数。

关键词: 低值PLT, CD61免疫学法, 光学法, 电阻抗法, CD-SAPPHIRE, 预防性血小板输注

Abstract: Objective

To evaluate and compare the advantages and disadvantages of 3 detection methods of CELL-DYN Sapphire hematology analyzer in the aspect of low platelet (PLT) detection.

Methods

A total of 100 patients whose platelet <50×10⁹/L caused by basis hematonosis or after chemotherapy were enrolled. PLT counts were determined by electrical impedance method (IPLT), optical method (OPLP) and CD61 immunological method (CD61-PLT). The results were analyzed comparatively with those of manual microscopy. Variance analysis, Passing-Bablok regression analysis and Bland-Altman bias analysis were performed by SPSS 19.0 and MedCalc V12.7.2.0 softwares statistically.

Results

ANOVA analysis showed that there was statistical significance for IPLT and OPLT with manual method (MPLT). (P=0.00, P=0.002). CD61-PLT and MPLT had no statistical significance (P=0.915). OPLT and CD61-PLT had good correlation with MPLT without statistical significance[slope 1.0, 95% confidence interval (CI):0.95-1.06, r=0.946 and slope 1.0, 95%CI: 0.99-1.01, r=0.998]. IPLT had poor correlation with MPLT with statistical significantce (slope 1.27, 95%CI: 1.10-1.44, r=0.845). According to variance analysis, the values of IPLT and OPLT were higher than those of MPLT (mean deviations were 6.3 and 1.3). CD61-PLT and MPLT had no significant difference(mean deviation was -0.02).

Conclusions

IPLT has significantly statistical difference with MPLT for low PLT determination, with poor correlation, and the result has a significant upward deviation. The means of OPLT and MPLT have statistical significance with good correlation, but the result has a still small upward deviation. The CD61-PLT and MPLT have no obvious difference with a good correlation, and the results are not significantly different. Therefore, it is recommended that we can use CD61-PLT as a new reference method and OPLT and IPLT as alternative methods.

Key words: Low platelet, CD61 immunological method, Optical method, Electrical impedance method, CD-SAPPHIRE, Prophylactic platelet transfusion

中图分类号:

R446.11

张驰, 张洪波. CELL-DYN Sapphire 血液分析仪的CD61免疫学法、光学法、电阻抗法在低值血小板计数中的比较与应用[J]. 检验医学, 2015, 30(3): 274-279.

ZHANG Chi, ZHANG Hongbo. Comparison and application of low platelet counts by CD61 immunological, optical, electrical impedance methods of CELL-DYN Sapphire hematology analyzer[J]. Laboratory Medicine, 2015, 30(3): 274-279.

图/表 8

表1 电阻抗法、光学法和CD61免疫学法PLT精密度测定结果(×109/L)

项目	低值			中值			高值
项目	电阻抗法	光学法	CD61免疫学法	电阻抗法	光学法	CD61免疫学法	电阻抗法	光学法	CD61免疫学法
$x -$	31.10	25.40	24.4	256.10	254.00	255.50	639.8	633.10	636.10
s	0.99	0.97	0.84	4.56	3.59	2.07	6.01	5.45	2.47
CV(%)	3.20	3.80	3.46	1.78	1.41	0.81	0.94	0.86	0.39

表1 电阻抗法、光学法和CD61免疫学法PLT精密度测定结果(×109/L)

项目	低值			中值			高值
项目	电阻抗法	光学法	CD61免疫学法	电阻抗法	光学法	CD61免疫学法	电阻抗法	光学法	CD61免疫学法
$x -$	31.10	25.40	24.4	256.10	254.00	255.50	639.8	633.10	636.10
s	0.99	0.97	0.84	4.56	3.59	2.07	6.01	5.45	2.47
CV(%)	3.20	3.80	3.46	1.78	1.41	0.81	0.94	0.86	0.39

表2 CD-Sapphire电阻抗法、光学法和免疫法与手工显微镜法计数PLT的比较

项目	电阻抗法	光学法	CD61免疫学法PLT
N	82	100	100
均值	35.11	26.45	25.12
s	13.68	13.06	12.72
MPLT均值	28.84	25.14	25.14
P值	0.706	0.755	0.801
P值*	0.00	0.002	0.915
差异均值	6.3	1.3	-0.02
差异均值s	7.2	4.1	0.71
差异均值95%CI	5.17~8.18	0.47~2.13	-0.12~0.16
r值	0.845	0.946	0.998
截距	-1.07	0.65	-0.15
截距95%CI	-4.98~3.30	-0.40~1.66	-0.38~0.15
斜率	1.27	1.00	1.00
斜率95%CI	1.10~1.44	0.95~1.06	0.99~1.01
回归方程	Y=-1.066 7+1.266 7X	Y=0.650 0+1.000 0X	Y=-0.150 0+1.000 0X

图1 电阻抗法与MPLT的回归分析和差异分布注:(a)Passing-Bablok回归分析,实线表示回归线,虚线表示95%CI,对角虚线表示参考线;(b)Bland-Altman偏倚分析,X轴表示2组数据点的均值,Y轴表示2组数据点的差值(电阻抗法-MPLT),实线表示差值的均值,虚线表示±1.96s,虚线表示差值的均值的95%CI

图2 光学法与MPLT的回归分析和差异分布注:(a)Passing-Bablok回归分析,回归图中实线表示回归线,虚线表示95% CI,对角中间的虚线为参考线;(b)Bland-Altman偏倚分析,X轴表示2组数据点的均值,Y轴表示2组数据点的差值(光学法-MPLT),实线表示差值的均值,虚线表示±1.96 s,虚线表示差值的均值的95%CI

图3 CD61免疫法与MPLT的回归分析和差异分布注:(a)Passing-Bablok回归分析,实线表示回归线,虚线表示95%CI,对角虚线为参考线;(b)Bland-Altman偏倚分析,X轴表示2组数据点的均值,Y轴表示2组数据点的差值(CD61免疫学法PLT-MPLT),实线表示差值的均值,虚线表示±1.96 s,虚线表示差值的均值的95%CI

表3 82例样本CD-Sapphire 电阻抗法与MPLT PLT计数相比存在的不合理PLT输注情况

PLT阈值 (×10⁹/L)	例数	输注不足 [例(%)]	PLT正确输注(例)	输注过度 [例(%)]
5	2	2(100%)	0	0(0)
10	3	3(100)	0	0(0)
20	24	19(79.2)	5	0(0)
50	80	8(10.0)^*	63	9(11.3)

表4 100例样本CD-Sapphire 光学法与MPLT PLT计数相比存在的不合理PLT输注情况

PLT阈值 (×10⁹/L)	例数	输注不足 [例(%)]	PLT正确输注(例)	输注过度 [例(%)]
5	7	2(28.6)	5	0(0)
10	16	4(25.0)	12	0(0)
20	42	10(23.8)	30	2(4.8)
50	98	1(1.0)^*	91	6(6.1)

表5 100例样本CD-Sapphire CD61免疫学法与MPLT PLT计数相比存在的不合理PLT输注情况

PLT阈值 (×10⁹/L)	例数	输注不足 [例(%)]	PLT正确输注(例)
5	7	0(0)	7
10	16	0(0)	16
20	42	2(4.8)	40
50	98	0(0)	98

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