Has the introduction of the European Parliament Directive 98/79/EC from 1998-10-27 - concerning in-vitro diagnostic devices (IVD-directive) influenced performance of hormone immunoassay kits in terms of precision and accuracy? Results from selected External Quality Assessment (EQA) schemes between 1993 and 2008

Clinical Laboratory

Volumn 55, Issue 3-4, 2009, Pages 86-105

  Wood, William Graham ^a  

^a Instand eV Society for Promotion of Quality Assurance in Medical Laboratories eV   (Germany)

Author keywords

Accuracy; European directive 98 79 EC; External quality assessment; Guidelines of the German Federal Medical Council; Longitudinal observations; Method comparison; Precision; Standardisation

Indexed keywords

ESTRADIOL; FOLLITROPIN; HYDROCORTISONE; LIOTHYRONINE; PARATHYROID HORMONE; PROGESTERONE; PROLACTIN; TESTOSTERONE; THYROGLOBULIN; THYROGLOBULIN ANTIBODY; THYROID ANTIBODY; THYROID PEROXIDASE ANTIBODY; THYROTROPIN; THYROTROPIN RECEPTOR ANTIBODY; THYROXINE;

ACCURACY; ANTIBODY LABELING; ARTICLE; AUTOMATION; CLINICAL OBSERVATION; CONTROLLED STUDY; DIAGNOSTIC KIT; HORMONE DETERMINATION; HUMAN; IMMUNOASSAY; IN VITRO STUDY; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; LABORATORY TEST; PROCESS OPTIMIZATION; QUALITY CONTROL; REFERENCE VALUE; TREND STUDY;

EUROPEAN UNION; HORMONES; HUMANS; IMMUNOASSAY; QUALITY CONTROL; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; STATISTICS, NONPARAMETRIC; STEROIDS; THYROXINE; TRIIODOTHYRONINE;

EID: 65649083380     PISSN: 14336510     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (22)

1. European Council Directive 98/79/EC of 1998-10-27 concerning in-vitro diagnostic devices. Official Journal L 331 of 1998-12-07 pp 0001-0037.
2. European Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Official Journal L 189/17 of 1990-07-20.
3. Gesetz über Medizinprodukte (Medizinproduktegesetz - MPG) in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I S. 3146), zuletzt geändert dutch Artikel 1 des Gesetzes vom 14. Juni 2007 (BGBI. I S. 1066).
4. Verordnung über Medizinprodukte - (Medizinprodukte-Verordming - MPV) vom 20. Dezember 2001 (BGBl I S. 3854) zuletzt geäridert durch Artikel 1 der Verordnung vom 16. Februar 2007 (BGBl I S. 155) und
5. Zweites Gesetz zur Änderung des Medizinproduktgesetzes (2. MPG-ÄndG) (BGBl I 3586-607, 18. Dezember 2001).
6. Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmedizinischer Untersuchungen-Beschluss des Vorstandes der Bundesärztekammer vom 24. August 2001. Deutsches Ärzteblatt 2001; 98: B2356-67.
7. Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriums-medizinischer Untersuchungen. Demsches Äzteblatt 2008; 105: A341-55.
8. Sozialgesetzbuch, Fünftes Buch, Gesetzliche Krankenversicherung, neunter Abschnitt, § 135a Verpflichtung zur Qualitätsversicherung. (Artikel1 des Gesetztes v. 20. Dezember 1998, BGBl. I S. 2477). Also: http://www.gesetze-im-internet-de /bundesrecht/sgb_5/gesamt.pdf
9. Marschner I, Wood WG, Scriba PC. The Munich-Model as external quality control educational programme. In: Rdioimmunoassay and related procedures in medicine 1982, International Atomic Energy Agency (IAEA), Vienna, 1982, pp. 591-600. ISBN 92-0-010482-7.
10. 4) im Serum: Bedeutung für die Erkermung methodischer Fehlerquellen. J Clin Chem Clin Biochem 1976; 14: 353-60.
11. 4) assay using the "Munich Model" J Clin Chem Clin Biochem 1980; 18: 511-9.
12. Wood WG, Hanke R, Reinauer H. Comparability of method results and performance in a national external quality assessment scheme between 1993 and 2003 using thyroid associated analytes as examples. Clin Lab 2004; 50: 333-46.
13. Wood WG, Hanke R. Comparability of method results and performance in a national external quality assessment scheme between 1993 and 2003 using thyroid associated antibodies as examples. Clin Lab 2004; 50: 209-22.
14. Pilo A, Zucchelli GC, Piro MA, Chiesa MR. Analytical performances achieved by the "Aria II" automatic system in a inter-laboratory survey for Triiodothyronine and thyroxine assays. J Automatic Chem 1983; 5: 157-8.
15. 3-uptake. J Automatic Chem 1981; 3: 201-3.
16. Levine S, Noth R, Loo A, Chopra U, Klee GG. Anomalous serum thyroxun measurements with the Abbott TDx procedure. Clin Chem 1990; 36:1038-40.
17. Fiore M, Mitchell J, Doan T, Nelson R, Winter G, Grandone C, Zeng K, Haraden R, Smith J, Harris K, et al. The Abbott IMx automated benchtop immumochemistry analyzer system. Clin Chem 1988; 34:1726-32.
18. Camara PD, Velletri K, Krupski M, Rosner M, Griffiths WC. Evaluation of the Boehringer Mannheim ES 300 immunoassay analyzer and comparison with enzyme inummoassay, fluorescence polarization immunoassay, and radioimmunoassay methods. Clin Biochem 1992; 25: 251-4.
19. Knedel M, Assmann G, Courbe A, van Impe L, Kattermann R, Keller H, Oellerich M, Küppers R, Meyer HD, Willnow P. Investigation of the performance of the ES 600 Enzymun-Test system. A multicentre study. J Clin Chem Clin Biochem. 1988; 26: 149-62.
20. Parnham AJ, Tarbit JF. "Delfia" and "Amerlite": two sensitive nonisotopic immunnassay systems for assay of thyrotropin compared. Clin Chem. 1987; 33: 1421-4.
21. Ekins RP. Immunoassay standardisation. Scand J Clin Lab 1991; 51 (Suppl 206): 33-46.
22. Thienpont LM. Accuracy in clinical chemistry - who will kiss Sleeping Beauty awake? Clin Chem Lab Med 2008; 46:1220-2.