Evaluation on the consistency of blind sample test results of 9 SARS-CoV-2 nucleic acid determination kits in Shanghai，China

doi:10.3969/j.issn.1673-8640.2023.08.013

Abstract

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

CLC Number:

R446.1

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.

Figures/Tables 4

References 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