Analysis of reagent lot-to-lot comparability tests in five immunoassay items

Annals of Clinical and Laboratory Science

Volumn 42, Issue 2, 2012, Pages 165-173

  Kim, Hyun Soo ^a   Kang, Hee Jung ^a   Whang, Dong Hee ^b   Lee, Seong Gyu ^c   Park, Min Jeong ^a   Park, Ji Young ^a   Lee, Kyu Man ^a  

^a Hallym University College of Medicine   (South Korea)

^b Inje University College of Medicine   (South Korea)

^c Bundang Jesaeng Hospital   (South Korea)

Author keywords

Immunoassay; Lot; Quality control; Reagent

Indexed keywords

ALPHA FETOPROTEIN; CA 19-9 ANTIGEN; FERRITIN; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B SURFACE ANTIGEN;

ACCURACY; ARTICLE; CONTROLLED STUDY; IMMUNOASSAY; LABORATORY; PRIORITY JOURNAL; QUALITY CONTROL;

ALPHA-FETOPROTEINS; CA-19-9 ANTIGEN; CALIBRATION; FERRITINS; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HUMANS; IMMUNOASSAY; INDICATORS AND REAGENTS; QUALITY CONTROL; REAGENT KITS, DIAGNOSTIC;

EID: 84864117853     PISSN: 00917370     EISSN: 15508080     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Kitchen AD and Newham JA. Lot release testing of serological infectious disease assays used for donor and donation screening. Vox Sang 2010;98:508-516.
2. Holzel W. Analytical variation in immunoassays and its importance for medical decision making. Scand J Clin Lab Invest Suppl 1991;205:113-119.
3. Kim HS, Choi SK, Ko YS, Chung D, Kim JM, Kim YJ, et al.Evaluation of allergen specific IgE assay on ADVIA Centaur immunoassay system. Korean J Lab Med 2006;26:362-368.
4. Relative change and difference. http://www.en.wikipedia.org/wiki/Percent_difference (Updated on 9 November 2010)
5. Hoefner DM and Yeo KT. Lot-to-lot inconsistency of anticardiolipin reagents. Clin Chem 2002;48:1625-1626.
6. Dufour DR. Lot-to-lot variation in anti-hepatitis C signal-tocutoff ratio. Clin Chem 2004;50:958-960.
7. Westgard JO. Quality requirement (CLIA and others). http://www.westgard.com/clia-quality.htm (Updated on October 2010)
8. Lasky FD. Book, software, and web site reviews: CLIA final rules for quality systems: Quality assessment issues and answers. Clin Chem 2005;51:1911-1912.
9. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem 1992;30:311-317.
10. Petersen PH, Ricos C, Stockl D, Libeer JC, Baadenhuijsen H, Fraser C, et al. Proposed guidelines for the internal qualitycontrol of analytical results in the medical laboratory. Eur J Clin Chem Clin Biochem 1996;34:983-999.
11. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest. 1999;59:491-500.
12. Ricos C, Iglesias N, Garcia-Lario J, Simon M, Cava F, Hernandez A, et al. Within-subject biological variation in disease: collected data and clinical consequences. Ann Clin Biochem 2007;44:343-352.
13. Clinical and Laboratory Standards Institute. Verification of comparability of patient results within one health care system: approved guideline. CLSI document C54-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2008.