1.Scheme Design and Results Analysis of Ground Bond Proficiency Testing.
Tao CHEN ; Yichuan ZHANG ; Dawei LU ; Baosheng GUO ; Bingzhen WEI
Chinese Journal of Medical Instrumentation 2015;39(6):454-456
Grounding impedance measurement is a traditional proficiency testing programs, 2014 proficiency testing program on the basis of original ability to verify, combined with actual detection need, innovation introduced two verification point of the power input socket and metal plane testing. This paper analyzes and discusses the results of the ability verification in 2014, and puts forward the points of attention and the recommended method of metal plane test.
Laboratories
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standards
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Laboratory Proficiency Testing
2.Discussion on evaluation mode of proficiency testing for heavy metal and harmful element detection in medicines.
Yao-Lei LI ; Hong-Yu JIN ; Xin-Hua XIANG ; Shuang-Cheng MA
China Journal of Chinese Materia Medica 2019;44(8):1724-1728
This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.
Cadmium
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analysis
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Laboratories
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Laboratory Proficiency Testing
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Lonicera
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chemistry
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Pharmaceutical Preparations
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standards
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Plant Preparations
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standards
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Trace Elements
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analysis
3.Report on HbA(1c) Proficiency Testing in Asia in 2012.
Masao UMEMOTO ; Tadao HOSHINO ; Tetsuo MIYASHITA ; Wataru TANI ; Katsuhiko KUWA
Annals of Laboratory Medicine 2015;35(3):352-355
In 2010, the Japan Diabetes Society decided to introduce the National Glycohemoglobin Standardization Program (NGSP) values into clinical practice. Accordingly, NGSP Certification of Japanese manufacturers of HbA(1c)-related diagnostic reagents and instruments was initiated in February, 2012, through an NGSP network laboratory, the Asian Secondary Reference Laboratory (ASRL) #1. Traceability to the NGSP reference system can be endorsed by manufacturer certification, as well as by the College of American Pathologists (CAP) survey. Nevertheless, only a few manufacturers participate in the CAP survey in Japan. Thus, proficiency testing (PT) was proposed and executed by ASRL #1. Single-donor whole-blood samples were used for the PT. The participated measurement systems were NGSP certified. Twenty-two laboratories obtained certification through ASRL #1; 2 through the Secondary Reference Laboratory (SRL) #8; and 9 through the SRL #9. The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value. In conclusion, PT using whole blood is useful in endorsing NGSP certification.
Asia
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Chromatography, High Pressure Liquid
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Enzyme Assays
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Hemoglobin A, Glycosylated/*analysis/standards
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Humans
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Immunoassay
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Japan
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Laboratory Proficiency Testing/*standards
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Quality Control
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Reference Standards
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Republic of Korea
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Societies, Scientific