上海地区9种新型冠状病毒核酸检测试剂盲样检测结果一致性分析

doi:10.3969/j.issn.1673-8640.2023.08.013

摘要/Abstract

摘要：

目的了解上海地区临床实验室新型冠状病毒（SARS-CoV-2）核酸检测结果的一致性，为医疗机构检验结果互认提供参考。方法收集上海市临床检验中心组织的2022年SARS-CoV-2核酸检测室间质量评价活动中参评实验室4次盲样检测结果和阳性结果循环阈值（Ct）数据，并进行分析。结果 249家参评实验室4次盲样检测9种检测试剂2个阴性盲样检测结果正确率和3个阳性盲样靶基因检出率均为100%。9种检测试剂3个阳性盲样ORF1ab基因和N基因Ct值x的差异范围分别为2.58~2.66和2.88~3.06；极差（R）范围分别为7.98~8.15和7.71~7.73。9种试剂中，有5种试剂组内ORF1ab基因和N基因Ct值变异系数（CV）均<5%。仅1种试剂检测结果组内和组间CV较大。结论上海地区临床实验室SARS-CoV-2核酸检测能力均能达到要求，但不同检测试剂Ct值差异较大，依据Ct值判读结果可能会产生假阴性或假阳性结果，应引起临床实验室和相关管理部门的重视。

关键词: 新型冠状病毒, 核酸检测, 盲样, 循环阈值, 室间质量评价

Abstract:

Objective To know the consistency of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） nucleic acid determination results of clinical laboratories in Shanghai，China. Methods The results of 4 SARS-CoV-2 nucleic acid blind sample tests and the cycle threshold（Ct）value of positive results in clinical laboratories were analyzed. Results Totally，249 clinical laboratories participating in the 4 blind sample tests used 9 kinds of determination kits to determine 2 negative blind samples and 3 positive blind samples. The correct rate of negative samples and the determination rate of positive samples were all 100%. The difference ranges of Ct values' x of ORF1ab gene and N gene in 3 positive samples of 9 determination kits were 2.58-2.66 and 2.88-3.06. The difference ranges of range（R） were 7.98-8.15 and 7.71-7.73，respectively. The coefficient of variation（CV） of Ct values of ORF1ab gene and N gene in 5 kit groups were all <5%. Only one kit results showed large variation within and between groups. Conclusions The determination capabilities of SARS-CoV-2 nucleic acid determination among clinical laboratories in Shanghai could all meet the requirements，but the Ct values of different determination kits are different. When interpreting the results based on the Ct value，false negative or positive results might occur，which should be paid attention by clinical laboratories and relevant management institutes.

Key words: Severe acute respiratory syndrome coronavirus 2, Nucleic acid determination, Blind sample, Cycle threshold, External quality assessment

中图分类号:

R446.1

杨雪, 朱俊, 蒋玲丽, 王青, 胡晓波. 上海地区9种新型冠状病毒核酸检测试剂盲样检测结果一致性分析[J]. 检验医学, 2023, 38(8): 776-780.

YANG Xue, ZHU Jun, JIANG Lingli, WANG Qing, HU Xiaobo. Evaluation on the consistency of blind sample test results of 9 SARS-CoV-2 nucleic acid determination kits in Shanghai，China[J]. Laboratory Medicine, 2023, 38(8): 776-780.

图/表 4

参考文献 12

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试剂编号	靶基因	最低检出限/（拷贝/mL）	循环数	界限值
A	ORF1ab、N	500	45	40
B	ORF1ab、N	350	45	37
C	ORF1ab、N、E	200	45	43
D	ORF1ab、N	500	32	30
E	ORF1ab、N	500	45	40
F	ORF1ab、N	200	41	39.5
G	ORF1ab、N、E	300	40	36
H	ORF1ab、N	200	45	40
I	ORF1ab、N	500	40	38

试剂编号	靶基因	最低检出限/（拷贝/mL）	循环数	界限值
A	ORF1ab、N	500	45	40
B	ORF1ab、N	350	45	37
C	ORF1ab、N、E	200	45	43
D	ORF1ab、N	500	32	30
E	ORF1ab、N	500	45	40
F	ORF1ab、N	200	41	39.5
G	ORF1ab、N、E	300	40	36
H	ORF1ab、N	200	45	40
I	ORF1ab、N	500	40	38

试剂编号	检测次数/次	浓度1				浓度2				浓度3
试剂编号	检测次数/次	x	M	CV/%	R	x	M	CV/%	R	x	M	CV/%	R
A	230	31.23	31.25	3.36	6.17	30.19	30.18	3.31	6.56	29.65	29.63	3.27	6.02
B	188	32.37	32.22	2.84	5.56	31.40	31.24	2.74	5.38	30.84	30.70	2.76	5.28
C	149	32.14	32.29	3.11	6.24	31.20	31.31	3.17	5.38	30.67	30.84	3.59	7.33
D	97	33.81	34.09	5.09	7.94	32.85	33.15	5.45	7.74	32.25	32.56	4.96	7.68
E	51	33.10	33.16	3.84	5.72	31.95	31.95	3.69	5.12	31.52	31.48	4.00	5.08
F	68	32.77	32.70	3.78	5.69	31.68	31.55	3.60	5.33	31.25	31.29	3.81	5.71
G	48	32.69	32.37	4.80	5.69	31.82	31.63	5.03	6.23	31.28	30.99	5.05	6.04
H	48	31.30	31.08	3.39	4.37	30.45	30.34	3.25	4.77	29.79	29.56	3.16	4.37
I	48	32.12	32.21	3.11	4.75	31.12	31.16	3.05	4.96	30.61	30.64	3.07	4.94

试剂编号	检测次数/次	浓度1				浓度2				浓度3
试剂编号	检测次数/次	x	M	CV/%	R	x	M	CV/%	R	x	M	CV/%	R
A	230	31.23	31.25	3.36	6.17	30.19	30.18	3.31	6.56	29.65	29.63	3.27	6.02
B	188	32.37	32.22	2.84	5.56	31.40	31.24	2.74	5.38	30.84	30.70	2.76	5.28
C	149	32.14	32.29	3.11	6.24	31.20	31.31	3.17	5.38	30.67	30.84	3.59	7.33
D	97	33.81	34.09	5.09	7.94	32.85	33.15	5.45	7.74	32.25	32.56	4.96	7.68
E	51	33.10	33.16	3.84	5.72	31.95	31.95	3.69	5.12	31.52	31.48	4.00	5.08
F	68	32.77	32.70	3.78	5.69	31.68	31.55	3.60	5.33	31.25	31.29	3.81	5.71
G	48	32.69	32.37	4.80	5.69	31.82	31.63	5.03	6.23	31.28	30.99	5.05	6.04
H	48	31.30	31.08	3.39	4.37	30.45	30.34	3.25	4.77	29.79	29.56	3.16	4.37
I	48	32.12	32.21	3.11	4.75	31.12	31.16	3.05	4.96	30.61	30.64	3.07	4.94

试剂编号	检测次数/次	浓度1				浓度2				浓度3
试剂编号	检测次数/次	x	M	CV/%	R	x	M	CV/%	R	x	M	CV/%	R
A	230	30.17	30.18	2.92	5.74	29.32	29.26	2.97	5.70	28.82	28.75	3.16	6.86
B	188	30.35	30.26	3.20	6.58	29.45	29.33	3.36	6.42	28.90	28.72	3.46	6.55
C	149	30.16	30.01	3.42	6.12	29.21	29.10	3.70	6.86	28.66	28.63	3.63	5.91
D	97	31.61	32.05	3.89	5.35	30.76	31.10	4.19	5.21	30.15	30.37	4.41	5.72
E	51	30.16	29.73	4.54	6.14	29.11	28.74	4.77	5.62	28.53	28.10	4.59	5.23
F	68	29.07	28.88	4.61	5.68	28.14	28.10	4.62	6.09	27.62	27.56	4.42	6.10
G	48	28.73	28.30	5.19	6.96	27.74	27.44	4.40	5.33	27.09	26.97	4.36	5.94
H	48	28.91	28.63	4.77	7.21	27.94	27.78	4.29	5.65	27.29	27.21	4.10	5.69
I	48	29.46	29.51	3.77	6.27	28.47	28.55	3.44	4.79	27.98	27.96	3.54	4.11