Commutability limitations influence quality control results with different reagent lots

Clinical Chemistry

Volumn 57, Issue 1, 2011, Pages 76-83

  Miller, W Greg ^a   Erek, Aybala ^a,b   Cunningham, Tina D ^a   Oladipo, Olajumoke ^c,d   Scott, Mitchell G ^c   Johnson, Robert E ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b VAKIF GUREBA TRAINING AND RESEARCH HOSPITAL   (Turkey)

^c WASHINGTON UNIVERSITY   (United States)

^d STATEN ISLAND UNIVERSITY HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

REAGENT;

ANALYTICAL EQUIPMENT; ARTICLE; CONTROLLED STUDY; HUMAN; IMMUNOASSAY; MEDICAL RECORD; QUALITY CONTROL; SAMPLE;

CLINICAL CHEMISTRY TESTS; DATA INTERPRETATION, STATISTICAL; HUMANS; INDICATORS AND REAGENTS; QUALITY CONTROL; REAGENT KITS, DIAGNOSTIC; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS;

EID: 78650973954     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2010.148106     Document Type: Article

References (19)

1. Rej R, Jenny RW, Bretaudiere JP. Quality control in clinical chemistry: Characterization of reference materials. Talanta 1984;31:851-62.
2. Franzini C, Ceriotti F. Impact of reference materials on accuracy in clinical chemistry. Clin Biochem 1998;31:449-57.
3. Cattazzo G, Franzini C, Melzi D'Eril G. Commutability of calibration and control materials for serum lipase. Clin Chem 2001;47:2108-13.
4. Miller WG. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes. Clin Chim Acta 2003;327:25-37.
5. Thienpont LM, Stockl D, Friedecky B, Kratochvila J, Budina M. Trueness verification in European external quality assessment schemes: Time to care about the quality of the samples. Scand J Clin Lab Invest 2003;63:195-201.
6. Miller WG, Myers GL, Ashwood ER, Killeen AA, Wang E, Thienpont LM, Siekmann L. Creatinine measurement: State of the art in accuracy and inter-laboratory harmonization. Arch Pathol Lab Med 2005;129:297-304.
7. Palmer-Toy DE, Wang E, Winter WE, Soldin SJ, Klee GG, Howanitz JH, Elin RJ. Comparison of pooled fresh frozen serum to proficiency testing material in College of American Pathologists surveys: Cortisol and immunoglobulin E. Arch Pathol Lab Med 2005;129:305-309.
8. Bock JL, Endres DB, Elin RJ, Wang E, Rosenzweig B, Klee GG. Comparison of fresh frozen serum to traditional proficiency testing material in a College of American Pathologists survey for ferritin, folate, and vitamin B12. Arch Pathol Lab Med 2005;129:323-7.
9. Schreiber WE, Endres DB, McDowell GA, Palomaki GE, Elin RJ, Klee GG, Wang E. Comparison of fresh frozen serum to proficiency testing material in College of American Pathologists surveys:α-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin, and prostate-specific antigen. Arch Pathol Lab Med 2005;129:331-7.
10. Miller WG, Myers GL, Ashwood ER, Killeen AK, Wang E, Ehlers GW, et al. State of the art in trueness and inter-laboratory harmonization for 10 analytes in general clinical chemistry. Arch Pathol Lab Med 2008;132:838-46.
11. Miller WG, Myers GL, Rej R. Why commutability matters [Editorial]. Clin Chem 2006;52: 553-4.
12. Vesper HW, Miller WG, Myers GL. Reference materials and commutability. Clin Biochem Rev 2007;28:139-47.
13. Miller WG. Matrix effects in the measurement and standardization of lipids and lipoproteins. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. 2nd ed. Washington, DC: AACC Press 2000;695-716.
14. Eckfeld JH, Copeland KR. Accuracy verification and identification of matrix effects. Arch Pathol Lab Med 1993;117:381-88.
15. Miller WG. The role of proficiency testing in achieving standardization and harmonization between laboratories. Clin Biochem 2009;42: 232-5.
16. Martindale RA, Cembrowski GS, Journault LJ, Crawford JL, Tran C, Hofer TL, et al. Validating new reagents: Roadmaps through the wilderness. Lab Medicine 2006;37:347-51.
17. Miller WG. Quality control. In: McPherson RA, Pincus MR, eds. Henry's clinical diagnosis and management by laboratory methods. 21st ed. St. Louis: Elsevier Saunders 2007:99-111.
18. Kutner MH, Natchsheim CJ, Neter J, Li W. Applied linear statistical models. 5th ed. Boston: McGraw- Hill Irwin; 2005.
19. Ames MH, Webster JT. On estimating approximate degrees of freedom. Am Stat 1991;45:45-50.