Performance evaluation of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation

doi:10.3969/j.issn.1673-8640.2015.09.014

Abstract

Abstract: Objective

To investigate the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation.

Methods

According to the instrument performance verification standards in the Clinical and Laboratory Standards Institute (CLSI) and the Health Industry Standard of the People's Republic of China, WS/T 406-2012: the Quality Standard of Routine Tests in Clinical Hematology, the performance of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation were evaluated. Platelet aggregation rate in healthy subjects was compared for correlation, which was detected by PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram.

Results

The within-run and inter-day precisions of PL-11 platelet analyzer were<1/3 of total error (7%), and the carry-over rate was 0.32%. In (4.12-1 380.4)×10⁹/L linear range, the regression equation slope was 1.03 (R²=0.993). The coincidence rate for platelet count by PL-11 platelet analyzer with reference method was 84%. There was no statistical significance of platelet aggregation rate among PL-11 platelet analyzer, LBY-NJ4 platelet tester and TEG-5000 thromboelastogram in 79 patients with type 2 diabetes mellitus (P>0.05). However, there was statistical significance in platelet aggregation rates before and after taking clopidogrel hydrogen(P<0.01).

Conclusions

PL-11 platelet analyzer can provide accurate and reliable results for platelet count and aggregation.

Key words: Platelet aggregation, Platelet analyzer, Continuous platelet count, Performance evaluation

CLC Number:

R446.62

CAI Yuchan, ZHAO Xuhong, HAN Ping, CHEN Changming, LI Zhi. Performance evaluation of PL-11 platelet analyzer in the detection of platelet count and platelet aggregation[J]. Laboratory Medicine, 2015, 30(9): 926-930.

Figures/Tables 5

项目	血小板浓度	$x ?$ (×10⁹/L)	最大值(×10⁹/L)	最小值(×10⁹/L)	s(×10⁹/L)	CV(%)
批内精密度	高值	1 175.35	1 276	1 091	56.61	4.82
	中值	139.75	151	130	5.78	4.14
	低值	24.30	30	22	1.69	6.95
日间精密度	高值	409	428	383	12.86	3.14
	中值	199	217	177	8.74	4.40
	低值	21	25	18	1.43	6.83

项目	血小板浓度	$x ?$ (×10⁹/L)	最大值(×10⁹/L)	最小值(×10⁹/L)	s(×10⁹/L)	CV(%)
批内精密度	高值	1 175.35	1 276	1 091	56.61	4.82
	中值	139.75	151	130	5.78	4.14
	低值	24.30	30	22	1.69	6.95
日间精密度	高值	409	428	383	12.86	3.14
	中值	199	217	177	8.74	4.40
	低值	21	25	18	1.43	6.83

项目	1	2	3
高值(×10⁹/L)	1 372	1 358	1 267
低值(×10⁹/L)	29	30	25

PL-11血小板分析仪(×10⁹/L)	参考方法 (×10⁹/L)	相对偏差 (%)
302	308	1.95
678	623	8.83
498	460	8.26
366	376	2.66
439	460	4.57
378	365	3.56
125	141	11.35
110	136	19.12
244	211	15.64
138	160	13.75
199	203	1.97
223	248	10.08
145	147	1.36
58	49	18.37
35	24	45.83^*
45	34	32.35^*
58	69	15.94
79	96	17.71
98	87	12.64
63	51	23.53^*
1 210	1 245	2.81
1 087	1 103	1.45
813	834	2.52
89	82	8.54
14	9	55.56^*

仪器	服药前	服药后	P值	t值
PL-11血小板分析仪	71.8±14.4	36.3±12.9^*	<0.01	8.957
LBY-NJ4血小板聚集仪	73.2±15.5	43.9±13.5^*	<0.01	7.754
TEG-5000血栓弹力图仪	73.9±9.5	41.9±17.4^*	<0.01	5.676

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