Evaluation of the homogeneity and stability of HBV DNA and HCV RNA samples used for proficiency testing

doi:10.3877/cma.j.issn.2095-5820.2015.01.006

Abstract

Abstract:

Objective

To evaluate the homogeneity and stability of the HBV DNA and HCV RNA samples used for proficiency testing prepared by Shanghai Center for clinical laboratory (SCCL).

Methods

The experiment was designed according to the Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing (CNAS-GL03) using samples from 2013 and 2014 proficiency testing. The homogeneity was evaluated by detecting 10 aliquots selected randomly from each positive sample. For stability, 6 aliquots of the randomly chosen 2 positive samples from each batch of proficiency test were analyzed one week after 2-8℃ preservation. Furthermore, synchronous stability was assessed by testing 6 aliquots of the above-mentioned 2 positive samples from the residue after distribution of proficiency testing. One way analysis of variance (ANOVA) and t test were used to analyze homogeneity and stability data, respectively.

Results

The F values of the 8 batches of HBV DNA samples were 0.6278,0.9861, 2.0286, 1.0507, 0.5305, 0.8244, 1.3941, 1.9126；P>0.05 respectively. The F values of the 7 batches of HCV RNA samples were 1.9664, 1.7057, 0.5418, 2.3076, 1.6260, 0.9965, 1.2252; respectively P>0.05. The t values of the 4 batches of HBV DNA samples were 1.96, 1.56, 0.92, 0.67 and were 1.17, 2.07,1.13, 0.52 in synchronous stability tests respectively . The t values of the 4 batches of HCV RNA samples were 2.05, 1.72, 1.63, 0.53 and were 0.66, 1.30, 0.66, 2.20 in synchronous stability tests respectively (P>0.05).

Conclusion

The HBV DNA and HCV RNA samples prepared by SCCL are both homogeneous and stable,which are suitable for proficiency testing.

Key words: Hepatitis B virus, Hepatitis C virus, Proficiency testing, Homogeneity, Stability

Lingli Jiang, Xueliang Wang, Yun Bao, Yanqun Xiao, Hualiang Wang. Evaluation of the homogeneity and stability of HBV DNA and HCV RNA samples used for proficiency testing[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2015, 03(01): 17-22.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhlcsysgldzzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.2095-5820.2015.01.006

https://zhlcsysgldzzz.cma-cmc.com.cn/EN/Y2015/V03/I01/17

Figures/Tables 6

计算值	2013年				2014年
计算值	1331	1332	1334	1335	1422	1423	1424	1425
$\bar{x}$	4.390 0	5.340 0	2.750 0	6.230 0	4.140 0	4.110 0	5.120 0	6.180 0
MS ₁	0.014 9	0.044 3	0.054 0	0.060 6	0.009 9	0.012 6	0.010 5	0.018 8
MS ₂	0.023 8	0.044 9	0.026 6	0.057 6	0.018 6	0.015 3	0.007 5	0.009 8
F值	0.627 8	0.986 1	2.028 6	1.050 7	0.530 5	0.824 4	1.394 1	1.912 6
P值	0.751 9	0.503 7	0.142 8	0.465 8	0.822 8	0.609 2	0.305 0	0.163 3

计算值	2013年				2014年
计算值	1331	1332	1334	1335	1422	1423	1424	1425
$\bar{x}$	4.390 0	5.340 0	2.750 0	6.230 0	4.140 0	4.110 0	5.120 0	6.180 0
MS ₁	0.014 9	0.044 3	0.054 0	0.060 6	0.009 9	0.012 6	0.010 5	0.018 8
MS ₂	0.023 8	0.044 9	0.026 6	0.057 6	0.018 6	0.015 3	0.007 5	0.009 8
F值	0.627 8	0.986 1	2.028 6	1.050 7	0.530 5	0.824 4	1.394 1	1.912 6
P值	0.751 9	0.503 7	0.142 8	0.465 8	0.822 8	0.609 2	0.305 0	0.163 3

计算值	2013年				2014年
计算值	1331	1333	1334	1335	1421	1423	1425
$\bar{x}$	5.210 0	3.920 0	4.480 0	5.250 0	4.420 0	3.630 0	5.240 0
MS ₁	0.019 2	0.058 0	0.078 6	0.026 5	0.015 7	0.020 9	0.022 0
MS ₂	0.009 8	0.034 0	0.145 1	0.011 5	0.009 6	0.021 0	0.018 0
F值	1.966 4	1.705 7	0.541 8	2.307 6	1.626 0	0.996 5	1.225 2
P值	0.153 4	0.208 7	0.814 8	0.104 4	0.229 7	0.497 5	0.375 9

计算值	2013年				2014年
计算值	1331	1333	1334	1335	1421	1423	1425
$\bar{x}$	5.210 0	3.920 0	4.480 0	5.250 0	4.420 0	3.630 0	5.240 0
MS ₁	0.019 2	0.058 0	0.078 6	0.026 5	0.015 7	0.020 9	0.022 0
MS ₂	0.009 8	0.034 0	0.145 1	0.011 5	0.009 6	0.021 0	0.018 0
F值	1.966 4	1.705 7	0.541 8	2.307 6	1.626 0	0.996 5	1.225 2
P值	0.153 4	0.208 7	0.814 8	0.104 4	0.229 7	0.497 5	0.375 9

检测次数	1331		1332		1423		1424
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	4.43	4.63	5.29	5.25	4.17	4.01	5.13	4.98
2	4.41	4.37	5.17	5.61	4.20	3.96	5.32	4.95
3	4.25	4.43	5.70	5.34	4.05	4.12	5.29	5.03
4	4.51	4.62	4.83	5.71	4.06	4.24	5.03	5.45
5	4.16	4.31	5.41	5.56	3.92	4.33	5.07	5.18
6	4.28	4.59	5.33	5.54	4.11	4.24	5.09	4.96
$\bar{x}$ ±s	4.34±0.13	4.49±0.14	5.29±0.29	5.50±0.17	4.08±0.10	4.15±0.15	5.16±0.12	5.09±0.20
t值		1.96		1.56		0.92		0.67
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1332		1423		1424
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	4.43	4.63	5.29	5.25	4.17	4.01	5.13	4.98
2	4.41	4.37	5.17	5.61	4.20	3.96	5.32	4.95
3	4.25	4.43	5.70	5.34	4.05	4.12	5.29	5.03
4	4.51	4.62	4.83	5.71	4.06	4.24	5.03	5.45
5	4.16	4.31	5.41	5.56	3.92	4.33	5.07	5.18
6	4.28	4.59	5.33	5.54	4.11	4.24	5.09	4.96
$\bar{x}$ ±s	4.34±0.13	4.49±0.14	5.29±0.29	5.50±0.17	4.08±0.10	4.15±0.15	5.16±0.12	5.09±0.20
t值		1.96		1.56		0.92		0.67
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1333		1421		1425
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	5.20	5.24	3.78	4.29	4.52	4.48	5.26	5.01
2	5.16	5.16	4.06	4.21	4.46	4.72	5.02	5.15
3	5.40	5.52	4.05	4.51	4.56	4.61	5.02	5.03
4	5.20	5.58	3.92	3.98	4.37	4.59	5.16	5.33
5	5.27	5.87	4.21	4.06	4.10	4.39	5.31	5.01
6	5.06	5.35	3.82	3.93	4.49	4.52	5.21	5.22
$\bar{x}$ ±s	5.21±0.11	5.45±0.26	3.97±0.16	4.16±0.22	4.42±0.17	4.55±0.11	5.16±0.12	5.13±0.13
t值		2.05		1.72		1.63		0.53
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1333		1421		1425
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	5.20	5.24	3.78	4.29	4.52	4.48	5.26	5.01
2	5.16	5.16	4.06	4.21	4.46	4.72	5.02	5.15
3	5.40	5.52	4.05	4.51	4.56	4.61	5.02	5.03
4	5.20	5.58	3.92	3.98	4.37	4.59	5.16	5.33
5	5.27	5.87	4.21	4.06	4.10	4.39	5.31	5.01
6	5.06	5.35	3.82	3.93	4.49	4.52	5.21	5.22
$\bar{x}$ ±s	5.21±0.11	5.45±0.26	3.97±0.16	4.16±0.22	4.42±0.17	4.55±0.11	5.16±0.12	5.13±0.13
t值		2.05		1.72		1.63		0.53
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1332		1423		1424
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	4.50	4.28	5.47	5.13	4.17	4.13	5.08	4.96
2	4.28	4.35	5.36	5.69	4.20	4.36	5.08	5.14
3	4.33	4.53	5.31	5.63	4.05	4.03	5.17	5.01
4	4.44	4.59	5.13	5.76	4.06	4.12	4.98	5.30
5	4.50	4.70	5.45	5.74	3.92	4.15	5.20	5.28
6	4.46	4.59	5.53	5.70	4.11	4.11	5.09	5.10
$\bar{x}$ ±s	4.42±0.09	4.51±0.16	5.37±0.14	5.61±0,24	4.08±0.10	4.15±0.11	5.10±0.08	5.13±0.14
t值		1.17		2.07		1.13		0.52
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1332		1423		1424
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	4.50	4.28	5.47	5.13	4.17	4.13	5.08	4.96
2	4.28	4.35	5.36	5.69	4.20	4.36	5.08	5.14
3	4.33	4.53	5.31	5.63	4.05	4.03	5.17	5.01
4	4.44	4.59	5.13	5.76	4.06	4.12	4.98	5.30
5	4.50	4.70	5.45	5.74	3.92	4.15	5.20	5.28
6	4.46	4.59	5.53	5.70	4.11	4.11	5.09	5.10
$\bar{x}$ ±s	4.42±0.09	4.51±0.16	5.37±0.14	5.61±0,24	4.08±0.10	4.15±0.11	5.10±0.08	5.13±0.14
t值		1.17		2.07		1.13		0.52
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1333		1421		1425
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	5.20	5.16	3.78	3.99	4.52	4.58	5.26	5.15
2	5.16	5.37	4.06	4.21	4.46	4.17	5.02	5.24
3	5.40	5.43	4.05	4.20	4.56	4.55	5.02	5.29
4	5.20	5.05	3.92	3.98	4.37	4.28	5.16	5.29
5	5.27	5.29	4.21	4.01	4.10	4.63	5.31	5.49
6	5.06	5.29	3.82	4.06	4.49	4.75	5.21	5.33
$\bar{x}$ ±s	5.21±0.11	5.26±0.14	3.97±0.16	4.08±0.10	4.42±0.17	4.49±0.22	5.16±0.12	5.30±0.11
t值		0.66		1.30		0.66		2.20
P值		>0.05		>0.05		>0.05		>0.05

检测次数	1331		1333		1421		1425
检测次数	第1天	1周	第1天	1周	第1天	1周	第1天	1周
1	5.20	5.16	3.78	3.99	4.52	4.58	5.26	5.15
2	5.16	5.37	4.06	4.21	4.46	4.17	5.02	5.24
3	5.40	5.43	4.05	4.20	4.56	4.55	5.02	5.29
4	5.20	5.05	3.92	3.98	4.37	4.28	5.16	5.29
5	5.27	5.29	4.21	4.01	4.10	4.63	5.31	5.49
6	5.06	5.29	3.82	4.06	4.49	4.75	5.21	5.33
$\bar{x}$ ±s	5.21±0.11	5.26±0.14	3.97±0.16	4.08±0.10	4.42±0.17	4.49±0.22	5.16±0.12	5.30±0.11
t值		0.66		1.30		0.66		2.20
P值		>0.05		>0.05		>0.05		>0.05

1	中国合格评定国家认可委员会. CNAS-GL03能力验证样品均匀性和稳定性评价指南[S]. 中国合格评定国家认可委员会，2006.
2	余男，甘明，詹希美，等. 乙型肝炎病毒核酸定量检测中不确定度的研究. 热带医学杂志，2007,7(4):310-314.
3	李金明, 主编. 实时荧光PCR技术[M]. 北京: 人民军医出版社，2011:135.
4	杨振华，王治国, 主编. 临床实验室质量管理[M]. 北京：人民卫生出版社，2003:89.
5	中国合格评定国家认可委员会. CNAS-CL03能力验证提供者认可准则ISO/IEC17043:2010. 2010.
6	金献忠，郑曙昭，丘寅. 能力验证样品均匀性和稳定性检验的统计方法[J]. 现代测量与实验室管理，2003,4(1):35-37.
7	吕文，陈晓健. 能力验证试样选择的探讨[J]. 现代测量与实验室管理, 2009, 1(1):36-39.

[1]	Yanbo Guo, Liang Ma, Gang Li, Wei Yan, Di Luo, Liang Yue, Weishan Wu. Progress on tibiofemoral dislocation after total knee arthroplasty [J]. Chinese Journal of Joint Surgery(Electronic Edition), 2024, 18(05): 658-671.
[2]	Xiaokang Gao, Jingyu Zhang, Jinwei Liu, Dongmu Tian, Yongcheng Hu, Weiguo Xu. Evolution and trend of motion and loading modes in hinge knee prosthesis [J]. Chinese Journal of Joint Surgery(Electronic Edition), 2024, 18(04): 505-516.
[3]	Zhiman Xiao, Xiqi Zhuang, Yu Gong. Early efficacy of Lasso-loop Gould procedure under arthroscope for treatment of lateral ankle instability [J]. Chinese Journal of Joint Surgery(Electronic Edition), 2024, 18(02): 280-284.
[4]	Minsi Liu, Rong Li, Mei Li. Diagnostic value of GGT-Plt ratio-based model for HBV-related hepatocellular carcinoma [J]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2024, 13(06): 831-835.
[5]	Haiqing Zhao, Wei Zhang, Qin Li. Clinical efficacy of inosine combined with immune checkpoint inhibitor in patients with metastatic colorectal cancer [J]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2024, 13(01): 54-62.
[6]	Tianxin Chen, Shengping Yang, Yuqi Zhu, Yun Gao, Shuai Zhang. Network Meta-analysis of surgical approaches for the treatment of anterior shoulder instability with glenoid bone loss [J]. Chinese Journal of Shoulder and Elbow(Electronic Edition), 2024, 12(04): 344-352.
[7]	Xiaokun Chen, Feng Zhu, Xinkun He, Chengzhou Bao, Jian Ruan. Clinical efficacy of allogeneic tendon double bundle reconstruction of the lateral ligament of the elbow joint in the treatment of chronic posterolateral rotational instability of the elbow joint [J]. Chinese Journal of Shoulder and Elbow(Electronic Edition), 2024, 12(02): 140-146.
[8]	Danmei Li, Jian Xu. Study on the correlation between the width and height of normal glenoid and its morphology in Chinese population by application of three-dimensional computed tomography [J]. Chinese Journal of Shoulder and Elbow(Electronic Edition), 2024, 12(01): 69-74.
[9]	Jia Dong, Kun Wang, Li Zhang. Prognostic nutritional index combined with immunoglobulin，fasting blood glucose level and serum alpha-fetoprotein in predicting poor prognosis in patients with HBV associated chronic acute liver failure after treatment [J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2024, 14(06): 555-559.
[10]	Jing Hu, Xiujin Yang, Zhiyun Hou. Changes of peripheral blood ISGs and their relationship with curative effect of interferon therapy in patients with HBV infection [J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2024, 14(04): 343-347.
[11]	Han Zhu, Shichao Zhuo, Di Wu, Yanan Zhu, Jiaxin Han. Correlation between preoperative plasma fibrinogen, blood lipid level, MMR expression and pathological characteristics and prognosis of colorectal cancer [J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2024, 14(02): 141-145.
[12]	Yuanbo Su, Qihui Li, Lu Li, Ming Lu, Fei Dong. Impact of immunochemotherapy on hepatitis B virus reactivation in HBsAg negative/anti-HBc positive T-cell non-Hodgkin's lymphoma patients: a retrospective cohort study [J]. Chinese Journal of Clinicians(Electronic Edition), 2024, 18(01): 1-6.
[13]	Wenxiao Wu, Dakui Zhang, Zhigang Sun, Zihan Han, Shaoxuan Chen, Zhiyong Hou, Bailong Sun, Jianzheng Jie. Novel biomarker for immunotherapy and prognostic in colon cancer with mismatch repair proficiency or microsatellite stability [J]. Chinese Journal of Clinicians(Electronic Edition), 2024, 18(01): 41-56.
[14]	Yumei Xiang, Shaorui Xu, Jie Kong, Jinmei Zhang, Han Li. The effect of linear increment rate on the digital subtraction angiography in an unstable state of the catheter tip [J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2024, 12(02): 161-165.
[15]	Chunlin Liu, Chang Liu, Dongyan Zhao, Duanping Li, Jianmei Liu, Qiulin Luo. Evaluation of measurement uncertainty for HBV DNA and HCV RNA by using internal quality control and proficiency testing data [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2024, 12(02): 91-96.

Please choose a citation manager

Content to export