scholarly journals EQUAL-qual: A European Program for External Quality Assessment of Genomic DNA Extraction and PCR Amplification

2007 ◽  
Vol 53 (7) ◽  
pp. 1349-1357 ◽  
Author(s):  
Claudio Orlando ◽  
Paolo Verderio ◽  
Ronald Maatman ◽  
Jan Danneberg ◽  
Simon Ramsden ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Dna Extraction ◽  
Dna Analysis ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Pcr Amplification ◽  
Molecular Techniques ◽  
The European Union ◽  
External Quality ◽  
Pcr Efficiency

Abstract 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.

Combi scheme: new combined internal/external quality-assessment scheme in The Netherlands

1991 ◽  
Vol 37 (7) ◽  
pp. 1196-1204 ◽  
Author(s):  
Herman Steigstra ◽  
Rob T Jansen ◽  
Henk Baadenhuijsen
Keyword(s):  
The Netherlands ◽  
Quality Assessment ◽  
Internal Control ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Laboratory Data ◽  
Data Communication ◽  
Professional Organization ◽  
Internal Quality ◽  
External Quality

Abstract The Dutch Foundation for Quality Assessment in Clinical Chemistry (SKZL) is the professional organization that conducts external quality-assessment schemes in The Netherlands. However, such schemes in fact assess the performance of the internal quality-control systems of the participating laboratories. In this paper we describe a new concept, relating the data for internal control materials with those for external samples and thereby leading to a combined external/internal scheme (Combi). The statistical principles underlying the Combi scheme are discussed and examples of the graphical presentation of the results are shown. Because the laboratory data are transmitted over the public telephone system to the computers of the SKZL, we also describe the principles of the data communication. At two-month intervals a statistical presentation is sent to all participants. The central database is updated daily with the received results, making possible an on-line consultation regarding the statistics of the accumulated findings of the control materials in use.

scholarly journals External Quality Assessment for the Detection of Chlamydia trachomatis in Urine Using Molecular Techniques in Belgium

2015 ◽  
Vol 2015 ◽  
pp. 1-8
Author(s):  
Bernard China ◽  
Kris Vernelen
Keyword(s):  
Chlamydia Trachomatis ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Bacterial Disease ◽  
External Quality ◽  
Sexually Transmitted ◽  
Low Sensitivity

Chlamydia trachomatis is a major cause of sexually transmitted bacterial disease worldwide. C. trachomatis is an intracellular bacterium and its growth in vitro requires cell culture facilities. The diagnosis is based on antigen detection and more recently on molecular nucleic acid amplification techniques (NAAT) that are considered fast, sensitive, and specific. In Belgium, External Quality Assessment (EQA) for the detection of C. trachomatis in urine by NAAT was introduced in 2008. From January 2008 to June 2012, nine surveys were organized. Fifty-eight laboratories participated in at least one survey. The EQA panels included positive and negative samples. The overall accuracy was 75.4%, the overall specificity was 97.6%, and the overall sensitivity was 71.4%. Two major issues were observed: the low sensitivity (45.3%) for the detection of low concentration samples and the incapacity of several methods to detect the Swedish variant of C. trachomatis. The reassuring point was that the overall proficiency of the Belgian laboratories tended to improve over time.

Quality Assessment of Tumor Marker Determinations: A Proposal for a Supraregional Scheme

1994 ◽  
Vol 9 (1) ◽  
pp. 48-52
Author(s):  
A. Piffanelli ◽  
M. Giganti ◽  
P. Colamussi ◽  
C. Cittanti ◽  
D. Pelizzola ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Tumor Marker ◽  
Tumor Markers ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
Realistic Information ◽  
Eqa Schemes

The use of tumor marker tests has increased progressively in the last decade concomitant with the advent of new monoclonal antibodies and their growing use in clinical oncology for various follow-up programs. External quality assessment (EQA) schemes widely adopted in clinical chemistry, have been extended in the last decade to immunoassays of hormones and tumor markers. EQA results can provide realistic information on the quality of the assays, performed under routine conditions. The goal of this article is to report the main results and discrepancies encountered so far in External Quality Assessment programs on tumor markers.

scholarly journals CLINICAL CHEMISTRY LABORATORY TESTING

2006 ◽  
Vol 12 (02) ◽  
pp. 139-144
Author(s):  
ASMA SHAUKAT ◽  
Shahid Irfan ◽  
TARIQ MAHMUD ARAIN ◽  
Soufia Farrukh ◽  
AMNA SHAHID
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Chemistry Laboratory ◽  
Test Results ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Chemical Test ◽  
Clinical Chemical ◽  
Clinical Chemistry Laboratory

Objective: To determine the affect of autonomy on clinical chemicaltesting in pathology department Quaid-i-Azam Medical College and to assess the change in the attitudes oflaboratorians and physicians Study design: Retrospective and comparative. Duration of study: 1-11-93 to 01-11-03Materials and Methods: A retrospective study was carried out from 1-11-93 to 01-11 03 in which records from 1-11-93to 1-11-03 were collected and evaluated .Separate record of each month’s revenue from clinical chemistry section wascalculated. In order to determine what changes have been brought about after autonomy a universal questionnairewas used to assess the attitudes of physicians and surgeons of hospital inquiring whether they noticed anyimprovement in the efficiency of clinical chemical test results after autonomy. 620 doctors were interviewed throughstructured questionnaire. The questionnaire was designed to assess the knowledge , attitude and practices of doctorstowards autonomy. In order to determine that who is the most beneficent of autonomy ,different records werecollected. and discussions were made with consultants. Results: Autonomy brought about a healthy change in the staffof clinical chemical section. Quality control has improved the morale of lab staff since technical deviations are morereadily identified and corrected within the lab, gross errors are rarely found by the clinicians and so their respect forand confidence in the lab has strengthened Replenishment of chemicals/reagents are timely made. The number ofavailable test has significantly increased which in turn has significantly raised the revenue generated since autonomy is awarded. Pilferage of chemicals has been stopped. Turn around time has been decreased. Clinical Chemical sectionparticipates in External Quality Assessment Scheme, NEQAPP (National External Quality Assessment ProgramPakistan),which is an essential part of the routine of a well –run lab. Patient is the most beneficent since autonomy isawarded to QMC/BVH, BWP. Conclusions: A significant improvement in the efficiency of the analytical performancehas strengthened the faith of laboratorians and physicians in the test results after autonomy

ESEAP: the national External Quality Assessment Scheme for clinical chemistry in Greece and Cyprus

2006 ◽  
Vol 44 (9) ◽  
Author(s):  
Othon Panagiotakis ◽  
Effie Anagnostou-Cacaras ◽  
Gerard Jullien ◽  
Angelos Evangelopoulos ◽  
Alexander Haliassos ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
External Quality Assessment Scheme

scholarly journals External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact

2018 ◽  
Vol 56 (8) ◽  
pp. 1238-1250 ◽  
Author(s):  
Andreas Bietenbeck ◽  
Wolf J. Geilenkeuser ◽  
Frank Klawonn ◽  
Michael Spannagl ◽  
Matthias Nauck ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Measurement Errors ◽  
External Quality Assessment ◽  
Blood Glucose Concentration ◽  
Clinical Chemistry ◽  
Point Of Care ◽  
Important Variable ◽  
External Quality ◽  
Reciprocal Effect ◽  
Glucose Testing

Abstract Background: Determination of blood glucose concentration is one of the most important measurements in clinical chemistry worldwide. Analyzers in central laboratories (CL) and point-of-care tests (POCT) are both frequently used. In Germany, regular participation in external quality assessment (EQA) schemes is mandatory for laboratories performing glucose testing. Methods: Glucose testing data from the two German EQAs “Reference Institute for Bioanalytics” (RfB) and “INSTAND – Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien” (Instand) were analyzed from 2012 to 2016. Multivariable odds ratios (OR) for the probability to reach a “good” result were calculated. Imprecision and bias were determined and clinical risk of measurement errors estimated. Results: The device employed was the most important variable required for a “good” performance in all EQAs. Additional participation in an EQA for CL automated analyzers improved performance in POCT EQAs. The reciprocal effect was less pronounced. New participants performed worse than experienced participants especially in CL EQAs. Imprecision was generally smaller for CL, but some POCT devices reached a comparable performance. Large lot-to-lot differences occurred in over 10% of analyzed cases. We propose the “bias budget” as a new metric to express the maximum allowable bias that still carries acceptable medical risk. Bias budgets were smallest and clinical risks of errors greatest in the low range of measurement 60–115 mg/dL (3.3–6.4 mmol/L) for most devices. Conclusions: EQAs help to maintain high analytical performances. They generate important data that serve as the foundation for learning and improvement in the laboratory healthcare system.

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