Method validation and reference materials

2004 ◽  
pp. 128-133
Author(s):  
Margreet Lauwaars ◽  
Elke Anklam
2004 ◽  
Vol 153 (1) ◽  
pp. 123-132 ◽  
Author(s):  
R.D. Josephs ◽  
M. Derbyshire ◽  
J. Stroka ◽  
H. Emons ◽  
E. Anklam

2004 ◽  
Vol 9 (4-5) ◽  
pp. 253-258 ◽  
Author(s):  
Margreet Lauwaars ◽  
Elke Anklam

Author(s):  
G. Bellocchi ◽  
Y. Bertheau ◽  
M. De Giacomo ◽  
A. Holst-Jensen ◽  
R. Macarthur ◽  
...  

2008 ◽  
Vol 91 (6) ◽  
pp. 1298-1302 ◽  
Author(s):  
Katherine E Sharpless ◽  
David L Duewer

Abstract National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of HealthOffice of Dietary Supplements and the U.S. Food and Drug Administration, is producing Standard Reference Materials (SRMs) for dietary supplements. These and other natural-matrix SRMs should be used in method validation, characterization of in-house quality control materials, and to establish traceability.


1997 ◽  
Vol 80 (4) ◽  
pp. 908-912 ◽  
Author(s):  
Wallace H Andrews

Abstract The paper discusses 5 major trends in food microbiology from an AOAC INTERNATIONAL perspective. The first trend, and perhaps the one with the greatest impact on food microbiology during the past 10 years, is the introduction of the rapid test kit. The development of these kits is a result of attempts to expedite, simplify, miniaturize, and automate methods. The second trend is the introduction of new method validation programs. AOAC INTERNATIONAL offers 2 alternatives to method validation by collaborative study: the Test Kit Performance Tested Method Program and the Peer-Verified Method Program. The third trend is the increasing use of microbiological reference materials. Applications of reference materials and of certified reference materials is addressed. The fourth trend is the evolving international character of not just AOAC INTERNATIONAL but other recognized scientific organizations as well. An attempt at method harmonization is one important consequence of this evolving internationalism. Moreover, there is a growing trend toward sharing of microbiological expertise on a global scale, reflecting our ever-shrinking geographical differences. The fifth trend is the implementation and increasing use of the Hazard Analysis Critical Control Point (HACCP) concept. The nature of the HACCP program and its influence on microbiological testing of the finished product are described.


2019 ◽  
Vol 57 (5) ◽  
pp. 648-658 ◽  
Author(s):  
Hong Liu ◽  
Lingkai Wong ◽  
Sharon Yong ◽  
Qinde Liu ◽  
Tang Lin Teo ◽  
...  

Abstract Background The measurement of hemoglobin A1c (HbA1c) is important for diagnosing diabetes mellitus as well as assessing glycemic control in diabetic patients. Commutable whole blood certified reference materials (CRMs) are needed in the measurement of HbA1c for method validation and/or as quality controls. Methods We developed three levels of hemolyzed whole blood CRMs for HbA1c. The certified values were determined using liquid chromatography-isotope dilution tandem mass spectrometry method (LC-IDMS/MS) where two “signature” hexapeptides of HbA1c and hemoglobin A0 (HbA0) were used as the calibration standards. The concentrations of the hexapeptide solutions were determined by amino acid analysis by the LC-IDMS/MS method using amino acid CRMs as the calibration standards. The commutability study was conducted by measuring 25 patient specimens and the whole blood CRMs by both LC-IDMS/MS method and various routine methods using six different clinical analyzers. Results The certified values were determined to be 35.1±2.0, 50.3±1.9 and 65.8±2.6 mmol/mol, respectively. These CRMs showed good commutability on five of the six clinical analyzers but showed poor commutability on one of the clinical analyzers that used similar method as two other analyzers where good commutability was observed. Conclusions With certified target values based on metrological traceability and good commutability on most of the clinical analyzers, the developed whole blood CRMs can be used for method validation or as quality control materials in the measurement of HbA1c. The commutability study results also underscored the need of commutability testing of clinical CRMs using various clinical analyzers.


2002 ◽  
Vol 35 (7) ◽  
pp. 1107-1116 ◽  
Author(s):  
Ileana Liliana Popescu ◽  
I. Gh. Tanase ◽  
Hassan Y. Aboul-Enein

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