Results analysis of external quality assessment program in newborn screening laboratories during 2003-2012 in China.

WANG Wei,ZHONG Kun,HE Fa-lin,WANG Zhi-guo.

Chinese Journal of Child Health Care ›› 2013, Vol. 21 ›› Issue (4) : 345-347.

PDF(477 KB)
PDF(477 KB)
Chinese Journal of Child Health Care ›› 2013, Vol. 21 ›› Issue (4) : 345-347.

Results analysis of external quality assessment program in newborn screening laboratories during 2003-2012 in China.

  • WANG Wei,ZHONG Kun,HE Fa-lin,WANG Zhi-guo.
Author information +
History +

Abstract

Objective To summarize and analyze the results of external quality assessment (EQA) of phenylalanine (Phe) and thyroid stimulating hormone (TSH) during 2003-2012 in China and then provide a benchmark for the neonatal screening testing. Methods Referring to Newborn Screening Quality Assurance Program of Centers for Disease Control And Prevention and GB/T 20470-2006:Requirements of external quality assessment for clinical laboratories.With 3 times one year,5 controls were distributed to the participated laboratories each time.Then the laboratories were asked to measure and report the results back in a specified time.With appropriate statistical analysis,the performance of each laboratory was evaluated. Results During 2003-2012,the percent of each method used for Phe was from 54.9% to 85.2% for Fluorescence Analysis,from 12.6% to 6.2% for Quantitative Enzymatic Method,and from 35.4% to 4.6% for Guthrie Test.The percent of each method used for TSH was from 44.8% to 70.7% for Time Resolved Fluoroimmunoassay(TRFIA),from 36.0% to 11.2% for Enzyme-Linked Immunosorbent Assay(ELISA),and from 17.5% to 13.0% for Fluorescent-Enzyme immunoassay(FEIA).The inter-laboratory coefficient of variation(CV) during the 10 years were 12.13%,17.15%,and 12.14%~12.97% for each method of Phe.And for TSH,the inter-laboratory CV were 14.14%,14.88%~27.20%,and 17.07%~34.98% for each method,respectively.The average acceptable rates of Phe and TSH were 95.3% and 89.4% for quantitative testing,97.8% and 98.0% for qualitative clinical judgment. Conclusion The CV of Fluorescence Analysis and TRFIA are less than others,thus the TRFIA is the first choice for TSH testing in China.The external quality assessment of Phe and TSH for newborn screening is helpful to discover the problem in this area and promote the national quality level.

Key words

newborn screening / external quality assessment / coefficient of variation / acceptable rate

Cite this article

Download Citations
WANG Wei,ZHONG Kun,HE Fa-lin,WANG Zhi-guo.. Results analysis of external quality assessment program in newborn screening laboratories during 2003-2012 in China.[J]. Chinese Journal of Child Health Care. 2013, 21(4): 345-347

References

[1] 国家质量技术监督局.GB/T 15483.1-1999,利用实验室间比对的能力验证PT[R].第1部分:能力验证计划的建立和运作.北京:中国标准出版社,1999.
[2] Clinical Laboratory Improvement Amendments of 1988.Public Law No.100-578-10th Congress[S].1988:2903-2908.
[3] 国家质量监督局.GB/T 20470-2006,临床实验室室间质量评价要求[R].北京:中国标准出版社,2006.
[4] 王治国,李小鹏,武平原.2001年全国新生儿疾病筛查实验室质量评价[J].中国公共卫生,2002,18(11):1324-1327.
[5] 王薇,王治国,李少男.全国新生儿疾病筛查实验室苯丙氨酸和促甲状腺素检测的质量评价[J].广东医学,2008,29(3):353-356.
[6] 钟堃,王治国,王薇,等.全国2009年新生儿遗传代谢病筛查项目切值分析[J].中国儿童保健,2009,18(12):982-984.
[7] 田国力,徐洪平,朱伟明,等.新生儿苯丙酮尿症两种实验室筛查方法的质量评价[J].检验医学,2007:22(2):171-173.
[8] 王治国.临床检验质量控制技术 [M].2版.北京:人民卫生出版社,2008.
PDF(477 KB)

Accesses

Citation

Detail

Sections
Recommended

/