2019年全国疟疾血涂片制作质量评估

doi:10.12140/j.issn.1000-7423.2022.06.010

摘要/Abstract

摘要：

了解和评估全国各省疟疾病例血涂片的制作质量，为指导疟疾消除后镜检质控等工作提供数据支持，探索血涂片质量评估的标准模式。抽取2019年各省（直辖市、自治区）每月第1例疟疾病例的血涂片1张（合计总数5例及以上），无疟疾病例则提供疟疾筛查时的阴性血涂片。组织10位持世界卫生组织疟疾镜检能力外部评估一级或二级证书的专家组成2个质量评估小组，集体讨论审定15项评估标准（①~）。将血涂片以省为单位分为2组，分发给2组专家进行双盲阅片评估。计算不同省份平均单张血涂片得分和血涂片制作合格率（每张血涂片满分15分，13分为合格）。对各省血涂片制作水平进行等级划分（合格率≥ 90%、80%~90%、 70%~80%、< 70%分别为A、B、C、D级）。将各省血涂片制作机构分为省级实验室和非省级实验室，比较不同实验室间单张血涂片平均得分和制作等级的差异。计算并比较所有血涂片在各评估标准项上的平均得分率。不同实验室间血涂片平均得分比较采用t检验，血涂片制作水平等级比较应用Person卡方检验或Fisher精确概率法。共收集28个省（直辖市、自治区）285张血涂片。全国单张血涂片平均得分为（13.3 ± 1.5）分，最高省份为14.8分，最低为8.9分，中位数为13.6分。血涂片总合格率为72.6%（207/285)，各省（直辖市、自治区）中血涂片合格率最高为100%，最低为20%。血涂片制作水平为A、B、C和D级的省（直辖市、自治区）分别为11、3、2和12个。省级实验室血涂片平均得分为（14.2 ± 0.2）分，高于非省级实验室[（13.0 ± 0.4）分]（t = 2.3，P < 0.05）。血涂片由非省级实验室制作的15个省（直辖市、自治区）中，A、B和D级制作水平的分别为4、2、9个；血涂片由省级实验室制作的9个省（直辖市、自治区）中，A、B、C和D级制作水平分别为6、1、1和1个。省级实验室血涂片的制作水平高于非省级实验室（Fisher精确概率法，P < 0.05）。不同省（直辖市、自治区）间单张血涂片平均得分的变异系数为11.2%，合格率的变异系数为37.5%。全国的血涂片在评估标准第②、③、⑧、⑨、和项的得分率较低（74.8%~85.3%），主要为厚血膜不合格；制作水平为C级的省级实验室主要扣分项为第和项，主要表现为染色后血膜中杂质较多，染色效果较差；制作水平为D级的省级实验室主要扣分项为第⑩、和项，主要为薄血膜中未观察到红细胞，原虫形态发生了变异。提示各省血涂片制作水平差异较大，省级实验室制作水平较高，基层单位血涂片制作应重点加强规范化。

关键词: 疟疾, 血涂片合格率, 血涂片, 质量控制

Abstract:

To understand and evaluate the quality of malaria blood smears in all provinces of China, provide data support for guiding the quality control of malaria microscopic examination during post-malaria elimination, and explore the standard model of evaluating the capability of preparing malaria blood smears. One blood smear of the first malaria case in a month in each province(direct-administered municipalities and autonomous regions) was collected, with a total of 5 cases or more in 2019. Provinces without malaria cases were provided with negative blood smears during malaria screening. Ten experts with WHO external assessment level 1 or level 2 certificates of malaria microscopy capability were organized to form two quality assessment teams. Fifteen assessment criteria (①-) were determined. All blood smears were divided into two groups for each province and sent to two teams of experts for double-blind reading evaluation. The single blood smear score and the qualified rate of blood smear in different provinces (15 points for each blood smear, 13 points for qualified) were calculated. The level of blood smear preparation in each province was graded (the qualification rate ≥ 90%, 80%-90%, 70%-80%, < 70% were A, B, C and D, respectively). The institutes that prepared the blood smears at different provinces were divided into provincial laboratories and non-provincial laboratories, and the differences of average single blood smear scores and preparation grades among different laboratories were compared. The average score rates of all blood smears were calculated and compared according to each evaluation standard. The average scores of blood smears between different laboratories were compared by t-test, and the levels of blood smears were compared by Person chi-square test or Fisher exact probability method. A total of 285 blood smears were collected from 28 provinces. The national average single blood smear score is (13.3 ± 1.5) with the highest score being 14.8 points, the lowest being 8.9 points, and the median being 13.6 points. The total rate of satisfied blood smears was 72.6% (207/285). The highest satisfaction rate in all provinces was 100%, and the lowest was 20%. The number of provinces categorized into A, B, C and D levels were 11, 3, 2 and 12, respectively. The average score in provincial laboratories was (14.2 ± 0.2), higher than that in non-provincial laboratories [(13.0 ± 0.4)] (t = 2.3, P < 0.05). Among the 15 provinces in which blood smears were prepared by non-provincial laboratories, 4 were marked as level A, 2 were marked as level B and 9 were marked as level D. Among the 9 provinces in which blood smears were prepared by provincial laboratories 6 were marked as level A, 1 was marked as level B, 1 was marked as level C, and 1 marked as level D. The level of preparing blood smears in the provincial laboratories was higher than that in the non-provincial laboratories (Fisher exact probability method, P < 0.05). The coefficient of variation of the average single blood smear score among different provinces (municipalities, autonomous regions) was 11.2%, and the coefficient of variation of the qualification rate was 37.5%. Nationally, the scoring rate of blood smear in items ②, ③, ⑧, ⑨, and of the evaluation criteria is low (74.8%-85.3%), which was mainly due to the unsatisfied thick blood smears. The main deducted points in provincial laboratories marked as level C are and, which mainly show that there are many contaminants in the blood smears after staining, and the staining is poor. The deducted points in the provincial laboratory marked as level D were ⑩, and. The main reason is that no red blood cells are observed in the thin films, and the protozoal morphology has changed. The levels of preparing blood smears varied in different provinces. The levels of preparing blood smears in provincial laboratories were higher than those in non-provincial laboratories. Normalized operation in preparing blood smears in basic units should be strengthened.

Key words: Malaria, Rate of qualified blood smear, Blood smear, Quality control

中图分类号:

R531.3

李美, 周何军, 夏志贵, 张丽, 涂宏, 尹建海. 2019年全国疟疾血涂片制作质量评估[J]. 中国寄生虫学与寄生虫病杂志, 2022, 40(6): 754-759.

LI Mei, ZHOU He-jun, XIA Zhi-gui, ZHANG Li, TU Hong, YIN Jian-hai. Quality evaluation on the preparation of the malaria blood smears at the national level in 2019[J]. Chinese Journal of Parasitology and Parasitic Diseases, 2022, 40(6): 754-759.

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血涂片制作实验室	实验室数量	血涂片数量	血涂片得分/分
血涂片制作实验室	实验室数量	血涂片数量	最高分	最低分	中位数	平均分
省级实验室	9	80	14.8	13.1	13.5	14.2 ± 0.6
非省级实验室
临床实验室	5	44	14.3	8.9	12.3	12.2 ± 0.1
县级CDC实验室	4	48	14.7	12.3	13.5	13.5 ± 1.0
其他实验室	6	65	14.8	11.7	13.2	13.3 ± 1.0
小计	15	157	14.8	8.9	13.2	13.0 ± 0.4

血涂片制作实验室	不同制作水平的实验室数量/个				合计
血涂片制作实验室	A级	B级	C级	D级	合计
省级实验室	6	1	1	1	9
非省级实验室
临床实验室	1	1	0	3	5
县级CDC实验室	1	1	0	2	4
其他实验室	2	0	0	4	6
小计	4	2	0	9	15

血涂片制作水平	省份数	最高分	最低分	中位数	平均分
A级	11	14.8	13.9	14.6	14.5 ± 0.3
B级	3	14.0	13.6	13.9	13.8 ± 0.2
C级	2	13.5	13.5	13.5	13.5 ± 0.0
D级	12	13.2	8.9	12.3	12.0 ± 1.4

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