TY - JOUR T1 - EQUAL-qual: a European program for external quality assessment of genomic DNA extraction and PCR amplification59 JF - Clin.Chem. Y1 - 2007 A1 - Orlando,C. A1 - Verderio,P. A1 - Maatman,R. A1 - Danneberg,J. A1 - Ramsden,S. A1 - Neumaier,M. A1 - Taruscio,D. A1 - Falbo,V. A1 - Jansen,R. A1 - Casini-Raggi,C. A1 - Malentacchi,F. A1 - Marubini,E. A1 - Pizzamiglio,S. A1 - Kris Vernelen A1 - Libeer,J.C. A1 - Palicka,V. A1 - Pazzagli,M. KW - a KW - ALL KW - an KW - analysi KW - analysis KW - Analyte KW - application KW - approach KW - approaches KW - article KW - AS KW - aspects KW - assessment KW - blood KW - chemistry KW - Clinical KW - Clinical Laboratory Techniques KW - community KW - conventional KW - Countries KW - data KW - Dna KW - Efficiency KW - Electrophoresis KW - EQA KW - European KW - European Union KW - Evaluating KW - external KW - External quality assessment KW - Genome,Human KW - genomic KW - Humans KW - identify KW - im KW - IS KW - isolation & purification KW - ITALY KW - journal KW - Laboratories KW - Male KW - means KW - method KW - methods KW - Molecular KW - ON KW - PCR KW - physiopathology KW - polymerase chain reaction KW - Practice KW - present KW - Print KW - PROGRAM KW - Programs KW - Project KW - qualitative KW - Quality KW - Quality Control KW - Research KW - Research Support KW - result KW - results KW - routine KW - Sample KW - Samples KW - SB - IM KW - series KW - standards KW - Statistical KW - Still KW - study KW - Target KW - Targets KW - Technique KW - Term KW - Test KW - tests KW - Universities KW - university KW - validity KW - VARIABILITY AB - BACKGROUND: Despite the rapid transition into routine clinical practice of molecular techniques based on PCR, external quality assessment (EQA) is still not widely available. The European Union and European Communities Confederation of Clinical Chemistry have supported the EQUAL project as a series of 3 different EQA programs for the assessment of molecular methods independently from analytes. We present the results from the EQUAL-qual program designed to evaluate the analytical aspects of DNA analysis by means of a conventional qualitative PCR experiment. METHODS: The EQUAL-qual program provided DNA, blood samples, and primer sets to participant laboratories to assess DNA extraction and PCR amplification. We have developed statistical procedures to identify laboratories performing poorly in DNA extraction (quality and quantity), PCR efficiency, and data interpretation after electrophoresis. RESULTS: An application to participate was obtained from 213 laboratories (from 25 countries), and 175 (82%) of laboratories submitted results for assessment. Questionable results in terms of quality and/or quantity of DNA derived from blood extractions were returned by 27% of laboratories (46 of 166). PCR efficiency showed high variability, with 3% of laboratories (5 of 163) showing a consistently low rate of amplification and 10% (18 of 175) not reporting the expected number of bands of the amplified targets. CONCLUSIONS: The results showed considerable variability in all phases of the experiment. The approach confirms the validity of EQA as a method for evaluating analytical aspects of PCR-based tests VL - 53 CP - 7 U1 - 38821 M3 - clinchem.2006.084004 [pii];10.1373/clinchem.2006.084004 [doi] ER -