Appraisal of diagnosis capacity of malaria reference laboratories in Henan Province during 2015—2019

doi:10.12140/j.issn.1000-7423.2022.06.009

Abstract

Abstract:

Objective To analyze the rechecking results of the reference laboratory for malaria diagnosis in Henan Province on malaria blood samples submitted by malaria diagnosis institutions at all levels and evaluate the malaria detection capacity of malaria diagnosis institutions in Henan Province. Methods Blood smears and whole blood samples, and the diagnosis institute information, diagnosis results and other information on the malaria cases and suspected malaria cases were collected in Henan Province from 2015 to 2019. The provincial malaria reference laboratory rechecked and tested the blood samples through three methods, including microscopy, rapid diagnostic test (RDT) and PCR, and analyzed the detection results, the misjudgment of worm species, and the positive coincidence and misjudgment of worm species in diagnostic institutions at all levels. The positive coincidence rate and misdiagnosis rate of different diagnostic institutions were analyzed by χ² test. Results From 2015 to 2019, the Malaria Diagnostic Reference Laboratory of Henan Province received a total of 1 194 malaria samples, of which 1 078 samples (90.3%) were confirmed positive, and 116 negative (9.7%) by using the three testing methods. The positive coincidence rate by PCR, RDT and microscopy was 98.7% (1 064/1 078), 96.9% (1 045/1 078) and 89.1% (960/1 078), respectively. A total of 934 samples had the same results between microscopy and PCR, among them, 711 were falciparum malaria, 58 vivax malaria, 32 quartan malaria and 133 ovale malaria. From 2015 to 2019, the rate of species misidentification showed a decreasing trend, which were 12.4% (25/202), 12.2% (28/230), 7.3% (15/206), 11.3% (27/239), and 5.4% (17/317), respectively. The misdiagnosis rates of Plasmodium falciparum, P. vivax, P. ovale, P. malariae, mixed infection and P. knowlesi were 3.7% (30/820), 23.4% (15/64), 39.9% (59/148), 34.3% (12/35), 9/10 and 1/1, respectively. The malaria cases diagnosed by disease prevention and control institutions (CDC), medical institutions and other institutions accounted for 23.7% (283/1 194), 74.5% (890/1 194) and 1.8% (21/1 194) respectively. Among the 283 cases diagnosed by disease control institutions, the positive coincidence rates of provincial, municipal and county (district) level disease control institutions were 9/9, 93.2% (69/674) and 91% (182/200), respectively, with no significant difference (χ² = 0.438, P > 0.05）. The error rate of Plasmodium species was 1/9, 20.3% (14/69) and 11.5% (21/182) respectively, with no significant difference (χ² = 3.271, P < 0.05). Among 890 cases diagnosed by medical institutions, the positive coincidence rates of provincial, municipal, county (district) and township (town) medical institutions were 81.0% (17/21), 91.7% (742/809), 92.2% (47/51) and 6/9 respectively, with a statistically significant difference (χ² = 55.392, P < 0.05); the misdiagnosis rate of Plasmodium species was 7/17, 10.9% (81/742), 10.6% (5/47) and 1/6 respectively, with statistical significance (χ² = 11.978, P < 0.05). Conclusion The local settings for diagnosis units of malaria cases in Henan Province are mainly medical institutions, and the detection capacity of malaria laboratories at all levels is generally high. It is imperative to continuously strengthen. The training for malaria diagnosis professionals in medical institutions to maintain the higher capacity of malaria diagnosis.

Key words: Malaria, Detection capacity, Evaluation, Henan

CLC Number:

R382.31

LI Su-hua, JI Peng-hui, ZHOU Rui-min, HE Zhi-quan, QIAN Dan, YANG Cheng-yun, LIU Ying, LU De-ling, WANG Hao, ZHANG Hong-wei, ZHAO Yu-ling. Appraisal of diagnosis capacity of malaria reference laboratories in Henan Province during 2015—2019[J]. CHINESE JOURNAL OF PARASITOLOGY AND PARASITIC DISEASES, 2022, 40(6): 748-753.

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References 17

[1]	World Health Organization. World malaria report 2022[R]. Geneva: WHO, 2022: 22-23.
[2]	Yang CY, Qian D, Lu DL, et al. Epidemiological analysis of malaria in Henan Province during 2016—2018[J]. Chin J Parasitol Parasit Dis, 2019, 37(5): 619-622. (in Chinese)
	(杨成运, 钱丹, 鲁德领, 等. 2016—2018年河南省疟疾疫情分析[J]. 中国寄生虫学与寄生虫病杂志, 2019, 37(5): 619-622.)
[3]	Tang LH. Diagnosis, treatment and management of imported malaria cases[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2010: 70-73. (in Chinese)
	(汤林华. 输入性疟疾的诊治与管理[M]. 上海: 上海科学技术出版社, 2010: 70-73.)
[4]	Li M, Xia ZG, Tang LH. Overviews on Plasmodium ovale wallikeri and its genetic detection system[J]. Chin J Parasitol Parasit Dis, 2014, 32(1): 64-67. (in Chinese)
	(李美, 夏志贵, 汤林华. 卵形疟原虫wallikeri亚种及其基因检测体系的研究进展[J]. 中国寄生虫学与寄生虫病杂志, 2014, 32(1): 64-67.)
[5]	National Health Commission of the People’s Republic of China. Diagnosis of malaria. Health industry standard of the People’s Republic of China (WS259—2015)[S]. Beijing: China Standards Press, 2015: 1-12. (in Chinese)
	(中华人民共和国国家卫生和计划生育委员会. 疟疾的诊断. 中华人民共和国卫生行业标准(WS259—2015)[S]. 北京: 中国标准出版社, 2015: 1-12.)
[6]	Zhou RM, Li SH, Gao LJ, et al. Diagnosis and analysis of the first imported case of Plasmodium knowlesi infection in Henan Province[J]. J Zhengzhou Univ Med Sci, 2018, 53(5): 610-613. (in Chinese)
	周瑞敏, 李素华, 高丽君, 等. 河南省首例输入性诺氏疟的诊断和分析[J]. 郑州大学学报(医学版), 2018, 53(5): 610-613.)
[7]	Berry A, Fabre R, Benoit-Vical F, et al. Contribution of PCR-based methods to diagnosis and management of imported malaria[J]. Med Trop (Mars), 2005, 65(2): 176-183.
[8]	Wang JZ, Li XS, Yin SQ, et al. Comparison on application of microscopy, RDT and PCR to malaria diagnosis[J]. J Trop Dis Parasitol, 2020, 18(1): 46-48, 58. (in Chinese)
	(王加志, 李希尚, 尹授钦, 等. 镜检、抗原检测和核酸检测方法在疟疾诊断中的应用比较[J]. 热带病与寄生虫学, 2020, 18(1): 46-48, 58.)
[9]	Tanizaki R, Kato Y, Iwagami M, et al. Performance of rapid diagnostic tests for Plasmodium ovale malaria in Japanese travellers[J]. Trop Med Health, 2014, 42(4): 149-153. doi: 10.2149/tmh.2014-07
[10]	Yerlikaya S, Campillo A, Gonzalez IJ. A systematic review: Performance of rapid diagnostic tests for the detection of Plasmodium knowlesi, Plasmodium malariae, and Plasmodium ovale monoinfections in human blood[J]. J Infect Dis, 2018, 218(2): 265-276. doi: 10.1093/infdis/jiy150 pmid: 29554284
[11]	Berzosa P, de Lucio A, Romay-Barja M, et al. Comparison of three diagnostic methods (microscopy, RDT, and PCR) for the detection of malaria parasites in representative samples from Equatorial Guinea[J]. Malar J, 2018, 17(1): 333. doi: 10.1186/s12936-018-2481-4
[12]	Johnston SP, Pieniazek NJ, Xayavong MV, et al. PCR as a confirmatory technique for laboratory diagnosis of malaria[J]. J Clin Microbiol, 2006, 44(3): 1087-1089. doi: 10.1128/JCM.44.3.1087-1089.2006 pmid: 16517900
[13]	Wang JZ, Feng J, Li XS, et al. Analysis of imported malaria in Tengchong City, Yunnan Province during 2016—2019[J]. Chin J Parasitol Parasit Dis, 2020, 38(4): 435-439. (in Chinese)
	(王加志, 丰俊, 李希尚, 等. 2016—2019年云南省腾冲市输入性疟疾疫情分析[J]. 中国寄生虫学与寄生虫病杂志, 2020, 38(4): 435-439.)
[14]	Zhang L, Feng J, Tu H, et al. Challenges in malaria elimination: the epidemiological characteristics of Plasmodium vivax in China from 2011 to 2018[J]. Chin J Parasitol Parasit Dis, 2019, 37(5): 532-538. (in Chinese)
	(张丽, 丰俊, 涂宏, 等. 消除疟疾的挑战: 2011—2018年全国间日疟疫情分析[J]. 中国寄生虫学与寄生虫病杂志, 2019, 37(5): 532-538.)
[15]	Zhu GD, Cao J. Progress and challenges of global malaria elimination[J]. Chin J Schisto Control, 2019, 31(1): 19-22, 52. (in Chinese)
	(朱国鼎, 曹俊. 全球消除疟疾进展及面临的挑战[J]. 中国血吸虫病防治杂志, 2019, 31(1): 19-22, 52.)
[16]	Wu K, Chen F, Xu MX, et al. Epidemic situation of imported malaria and diagnostic capabilities of medical institutions in Wuhan City from 2008 to 2017[J]. Chin J Schisto Control, 2018, 30(3): 289-294. (in Chinese)
	(吴凯, 陈芳, 徐明星, 等. 2008—2017年武汉市境外输入性疟疾疫情及诊断能力分析[J]. 中国血吸虫病防治杂志, 2018, 30(3): 289-294.)
[17]	Yang WZ, Zhou XN. New challenges of malaria elimination in China[J]. Chin J Prev Med, 2016, 50(4): 289-291. (in Chinese) doi: 10.3760/cma.j.issn.0253-9624.2016.04.001 pmid: 27029356
	(杨维中, 周晓农. 中国在疟疾消除阶段面临的新挑战[J]. 中华预防医学杂志, 2016, 50(4): 289-291.)

类型 Character	镜检阳性数（阳性符合率/%） Microscopy(coincidence rate/%)	PCR阳性数（阳性符合率/%） Polymerase chain reaction(coincidence rate/%)	RDT阳性数（阳性符合率/%） Rapid diagnostic test(coincidence rate/%)	最终诊断 Final diagnosis
恶性疟原虫 P. falciparun	721（87.9）	807（98.4）	830（101.2）	820
间日疟原虫 P. vivax	58（90.6）	64（100）		64
三日疟原虫 P. malariae	32（91.4）	35（100）		35
卵形疟原虫 P. ovale	146（98.7）	141（95.3）		148
诺氏疟原虫 P. knowlesi	1（100）	1（100）		1
混合感染 Mixed infection	1（10）	10（100）		10
阳性^a Positive^a	1	6	215
阴性 Negative	202	125	144	116
其他^b Others^b	32	5	5
合计 Total	1 194	1 194	1 194	1 194

镜检 Microscopy	PCR检测PCR detection
	恶性疟原虫 P. falciparun	间日疟原虫 P. vivax	三日疟原虫 P. malariae	卵形疟原虫 P. ovale	诺氏疟原虫 P. knowlesi	混合Mixed		无血样 No samples	阳性 Positive	阴性 Negative	合计 Total
	恶性疟原虫 P. falciparun	间日疟原虫 P. vivax	三日疟原虫 P. malariae	卵形疟原虫 P. ovale	诺氏疟原虫 P. knowlesi	Pf/Po	Pm/Po	无血样 No samples	阳性 Positive	阴性 Negative	合计 Total
恶性疟原虫 P. falciparun	711					2		4		4	721
间日疟原虫P. vivax		58									58
三日疟原虫 P. malariae			32								32
卵形疟原虫P. ovale				133		5	1		6	1	146
混合Mixed（PF/PO）						1					1
诺氏疟原虫 P. knowlesi					1						1
阳性Positive	1										1
无血片No slides	10		1	2						10	23
未镜检No microscopy	5		1	2						1	9
阴性Negative	80	6	1	4		1		1		109	202
合计 Total	807	64	35	141	1	9	1	5	6	125

年份 Year	误判率/% Misjudgment rate/%
年份 Year	恶性疟原虫 P. falciparun	间日疟原虫 P. vivax	三日疟原虫 P. malariae	卵形疟原虫 P. ovale
2015	1.3（2/152）	2/9	6/8	56.0（14/25）
2016	3.5（6/171）	3/12	3/8	48.2（13/27）
2017	1.9（3/155）	3/19	2/4	6/17
2018	2.2（3/134）	2/9	0/5	38.1（16/42）
2019	1.4（3/208）	4/14	1/10	25.0（9/36）
合计Total	2.1（17/820）	23.4 (15/64)	34.3 (12/35)	39.9（59/148）

诊断机构Diagnostic institutions	阳性符合率/% Positive rate/%	虫种误判率/% Misdiagnosis rate/%
疾控机构 CDC
省级疾控机构Provincial-level CDC	9/9	1/9
地市级疾控机构 Prefecture-level CDC	93.2(69/74)	20.1(14/69)
县（区）级疾控机构 County(district)-level CDC	91.0(182/200)	11.5(21/182)
医疗机构 Medical institutions
省级医疗机构 Provincial-level medical institutions	81.0(17/21)	7/17
地市级医疗机构 Prefecture-level medical institutions	91.7(742/809)	10.9(81/742)
县（区）级医疗机构 County(district)-level medical institutions	92.2(47/51)	10.6(5/47)
乡（镇）级医疗机构 Township-level medical institutions	6/9	1/6
其他 Other	28.6(6/21)	1/6