Analytical Performance of Ca 19.9, Ca 125 and Ca 15.3 Assays as Observed through an External Quality Assessment Program

1994 ◽  
Vol 9 (1) ◽  
pp. 43-47 ◽  
Author(s):  
G.C. Zucchelli ◽  
A. Pilo ◽  
M.R. Chiesa ◽  
S. Masini ◽  
A. Clerico
Keyword(s):  
Monoclonal Antibody ◽  
Quality Control ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Ca 125 ◽  
External Quality ◽  
Ca 15.3 ◽  
Assessment Program ◽  
Ca 19.9 ◽  
Control Samples

Immunoassays of the tumor markers CA 19.9, CA125 and CA 15.3 are generally acknowledged to be a useful tool in the management of cancer patients. As a consequence, many methods developed by different companies are now commercially available. However, discrepancies have been described in the results of marker determinations even when the same monoclonal antibody was used. An external quality assessment (EQA) was carried out; starting from 1989 about 110 laboratories participated; since December 1991 the program was linked with the interlaboratory program Oncocheck organized by the Service de Radiopharmacie et Radioanalyse, University of Lyon. At present more than 200 laboratories of many European countries are involved: cumulatively 47 quality control samples have been prepared and sent to the participants. This manuscript is a report on data collected for CA 19.9, CA 125, and CA 15.3.

Systematic differences between commercial immunoassays for free thyroxine and free triiodothyronine in an external quality assessment program

1994 ◽  
Vol 40 (10) ◽  
pp. 1956-1961 ◽  
Author(s):  
G C Zucchelli ◽  
A Pilo ◽  
M R Chiesa ◽  
S Masini
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Normal Serum ◽  
Free Thyroxine ◽  
Free Triiodothyronine ◽  
External Quality ◽  
Assessment Program ◽  
Serum Pool ◽  
Back Titration ◽  
Control Samples

Abstract Data collected in a national external quality assessment program for free thyroxine (fT4) and free triiodothyronine (fT3) were analyzed to evaluate the performance of 10 method/kits with 26 control samples distributed to approximately 170 laboratories. The control materials were normal serum pools, pooled sera supplemented with thyroid hormones, a pregnancy serum pool, serum pooled from patients with familial dysalbuminemic hyperthyroxinemia (FDH), and a normal serum pool progressively diluted. The between-laboratory variability (CV) was approximately constant in normal and supplemented pools for fT4 (15.3%) and fT3 (24.0%) but markedly increased in diluted, pregnancy, and FDH pools (21.9-35.2% for fT4 and 28.6-66.5% for fT3) because of increases in systematic between-kit differences in control samples with altered binding-protein capacity. Moreover, free hormone concentrations measured in progressively diluted sera averaged lower than in undiluted samples. This decrease of concentration was less for back-titration or labeled-antibody techniques and greater for labeled-analog methods; only the method involving adsorption to cross-linked dextran (Sephadex) was unaffected by dilution. Evaluation of the reproducibility of the method/kits showed between-assay, between-laboratory precision ranging from 7.8% to 17.0% for fT4 and from 9.8% to 20.3% for fT3.

scholarly journals External Quality Assessment Practices in Clinical Biochemistry Laboratory: What is the need?

2020 ◽  
Vol 18 (1) ◽  
pp. 86-92
Author(s):  
A. Niraula ◽  
M. Bataju
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Assessment ◽  
Full Text ◽  
Clinical Biochemistry ◽  
External Quality Assessment ◽  
Review Article ◽  
Laboratory Accreditation ◽  
External Quality ◽  
Assessment Program

Health Care services is considered as an amalgamation between the doctor undergoing the examination and laboratory personnel behind the proper diagnosis of the patient. It has evolved to a large extent from a simple process of examination to handling the prescription to the patient. During this evolution, there has been a remarkable development in the field of laboratory diagnosis. A good laboratory is abided by the rule of quality services including quality control; both internal and external. External quality assessment program contributes to the long term accuracy of the analytical method used by the laboratory. It determines the number of quality element of the practicing laboratory and helps in the upliftment of the status of the laboratory to laboratory accreditation and certification. This review article is intended to review the importance of the external quality assessment program over internal quality control, its need in the laboratory and the current practices in external quality assessment. Medline search was done for the articles published in English language from 1945 to 2018. Keywords employed to search the articles were external quality assessment, EQA programs, quality assurance, and quality control in clinical biochemistry, respectively. We searched for any articles with the details of external quality assessment tools that were original articles, review, editorial and the official website of the EQAS program. The unavailable articles were searched through research gate and the authors were requested for full text. A total of 5 full text original research article were found and rest of the articles like review article, editorial, national policy were studied in detail. Standard textbooks for clinical chemistry and chapters for EQA under quality assurance was reread in detail. Studies and policy makers have depicted that External Quality Assessment scheme (EQAS) as an integral component for the efficient and high quality laboratory operation. The western countries haizve their own laboratory accreditation body which conducts the EQAS program and offers participation to other clinical laboratories. Countries in South East Asia have shown to be burgeoning in the field of EQA program with establishment of their own laboratory accreditation bodies and incorporating the non-accredited laboratories in EQA programs.

Applicability of various quality-control sera to assay of high-density lipoprotein cholesterol.

1980 ◽  
Vol 26 (7) ◽  
pp. 903-907
Author(s):  
D G Bullock ◽  
T J Carter ◽  
S V Hughes
Keyword(s):  
Quality Control ◽  
High Density Lipoprotein ◽  
Quality Assessment ◽  
High Density Lipoprotein Cholesterol ◽  
External Quality Assessment ◽  
Density Lipoprotein ◽  
High Density ◽  
Lipoprotein Cholesterol ◽  
Internal Quality ◽  
External Quality

Abstract Effective internal quality control and external quality assessment of high-density lipoprotein cholesterol assay is made difficult by analyte instability, and the suitability of quality-control sera for this purpose has not been studied. We have therefore investigated the properties of 25 different control sera from 15 suppliers by estimating within-batch precision for the two precipitation procedures used most widely (phosphotungstate/Mg2+ and heparin/Mn2+ with enzymic measurement of cholesterol. Some sera had properties similar to those of fresh human serum, but others demonstrated poor precision for one or both procedures or contained apparent high-density lipoprotein cholesterol in unphysiological concentrations. A study of six sera indicated that between-batch precision was consistent with the within-batch findings. We found that eight of the 25 batches of quality-control serum we investigated may be used for internal quality control and external quality assessment of high-density lipoprotein cholesterol assay.

The Italian pilot external quality assessment program for cystic fibrosis sweat test

2016 ◽  
Vol 49 (7-8) ◽  
pp. 601-605 ◽  
Author(s):  
Marco Salvatore ◽  
Giovanna Floridia ◽  
Annalisa Amato ◽  
Federica Censi ◽  
Claudio Carta ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Sweat Test ◽  
External Quality ◽  
Assessment Program

External Quality Assessment Program for Newborn Screening of Amino Acids in China

2019 ◽  
Vol 65 (03/2019) ◽  
Author(s):  
Falin He ◽  
Wei Wang ◽  
Chaowen Yu ◽  
Kun Zhong ◽  
Shuai Yuan ◽  
...  
Keyword(s):  
Amino Acids ◽  
Newborn Screening ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
External Quality ◽  
Assessment Program
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