A UK National External Quality Assessment Scheme (UK Neqas) for Molecular Genetic Testing for the Diagnosis of Familial Thrombophilia

1999 ◽  
Vol 82 (11) ◽  
pp. 1556-1557 ◽  
Author(s):  
S. Kitchen ◽  
I. Jennings ◽  
T. A. L. Woods ◽  
F. E. Preston
Keyword(s):  
Genetic Testing ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Molecular Genetic ◽  
Molecular Genetic Testing ◽  
External Quality ◽  
External Quality Assessment Scheme

The UK National External Quality Assessment Scheme (UK NEQAS) for molecular genetic testing in haemophilia

2006 ◽  
Vol 96 (11) ◽  
pp. 597-601 ◽  
Author(s):  
Anne Goodeve ◽  
Marian Hill ◽  
Ian Jennings ◽  
Steve Kitchen ◽  
Isobel Walker ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Genetic Testing ◽  
Quality Assessment ◽  
Cell Line ◽  
External Quality Assessment ◽  
Molecular Genetic ◽  
Molecular Genetic Testing ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
The Uk

SummaryMolecular genetic analysis of families with haemophilia and other inherited bleeding disorders is nowa common laboratory investigation. In contrast to phenotypic testing in which strict quality control is adhered to, in haemophilia molecular genetic testing there has been a lack of any external quality assurance schemes. In 1998 the UK National External Quality Assessment Scheme (UK NEQAS) established a pilot quality assurance scheme for molecular genetic testing in haemophilia. Results from three initial surveys highlighted problems with the quality of samples when used to screen for the intron 22 inversion within the F8 gene. The scheme was re-launched in 2003, and since that time there have been five exercises involving whole blood or immortalised cell line DNA. The results together with an overall summary of the exercise are subsequently returned to participants. Exercises to date have focused exclusively on haemophilia A and QA, material has included screening for the intron 1 and intron 22 inversions as well as sequence analysis. A paper exercise circulated in 2003 highlighted problems with the format of reports and, following feedback to participants, onlya single error has been made in the subsequent four exercises. Participating laboratories now receive QA material every six months. Immortalised cell line material was introduced in 2005 and was shown to perform well. This will allow expansion of the scheme and a reduction in the dependence on blood donation.

scholarly journals Thirteen Years of an International External Quality Assessment Scheme for Genotyping: Results and Recommendations

2016 ◽  
Vol 62 (8) ◽  
pp. 1084-1095 ◽  
Author(s):  
Verena Haselmann ◽  
Wolf J Geilenkeuser ◽  
Simona Helfert ◽  
Romy Eichner ◽  
Svetlana Hetjens ◽  
...  
Keyword(s):  
Genetic Testing ◽  
Quality Assessment ◽  
Error Rate ◽  
External Quality Assessment ◽  
Molecular Genetic ◽  
Genetic Diagnostics ◽  
External Quality ◽  
Sequence Variations ◽  
Therapeutic Decisions

Abstract BACKGROUND Suboptimal laboratory procedures resulting in genotyping errors, misdiagnosis, or incorrect reporting bear greatly on a patient's health management, therapeutic decisions made on their behalf, and ultimate outcome. Participation in external quality assessment (EQA) is a key element of quality assurance in molecular genetic diagnostics. Therefore, the Reference Institute for Bioanalytics has tried for 13 years to improve the quality of genetic testing by offering an EQA for different clinically relevant sequence variations. METHODS Within each of the biannual EQA schemes offered, up to 18 samples of lyophilized human genomic DNA were provided for up to 50 different molecular genetic tests. Laboratories were asked to use their routine procedures for genotyping. At least 2 expert peer assessors reviewed the final returns. Data from 2002 to 2014 were evaluated. RESULTS In total, 82 462 reported results from 812 characterized samples were evaluated. Globally, the number of participants increased each year along with the number of sequence variations offered. The error rate decreased significantly over the years with an overall error rate of 1.44%. Additionally, a decreased error rate for samples repeated over time was noted. Interestingly, the error rate showed a high difference depending on the locus analyzed and the method used. CONCLUSIONS Based on the evaluation of this long-term EQA scheme, various recommendations can be given to improve the quality of molecular genetic testing, such as the use of 2 different methods for genotyping. Furthermore, some methods are inappropriate for analysis of certain sequence variations.

Establishing an Accuracy Basis for the Vitamin D External Quality Assessment Scheme (DEQAS)

2017 ◽  
Vol 100 (5) ◽  
pp. 1277-1287 ◽  
Author(s):  
Carolyn Q Burdette ◽  
Johanna E Camara ◽  
Federica Nalin ◽  
Jeanita Pritchett ◽  
Lane C Sander ◽  
...  
Keyword(s):  
Vitamin D ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Measurement Procedure ◽  
Binding Assays ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Hydroxyvitamin D ◽  
Target Values ◽  
High Concentrations

Abstract Until recently, the Vitamin D External Quality Assessment Scheme (DEQAS) assessed the performance of various assays for the determination of serum total 25-hydroxyvitamin D [25(OH)D] by using a consensus mean based on the all-laboratory trimmed mean (ALTM) of the approximately 1000 participants' results. Since October 2012, the National Institute of Standardsand Technology (NIST), as part of the Vitamin D Standardization Program, has participated in DEQAS by analyzing the quarterly serum sample sets using an isotope dilution LC-tandem MS (ID LC-MS/MS) reference measurement procedure to assign an accuracy-based target value for serum total 25(OH)D. NIST has analyzed90 DEQAS samples (18 exercises × 5 samples/exercise) to assign target values. The NIST-assigned values are compared with the ALTM and the biases assessed for various assays used by the participants, e.g., LC-MS/MS, HPLC, and several ligand-binding assays. The NIST-value assignment process and the resultsof the analyses of the 90 DEQAS samples are summarized. The absolute mean bias between the NIST-assignedvalues and the ALTM was 5.6%, with 10% of the samples having biases >10%. Benefits of the accuracy-based target values are presented, including for sample sets with high concentrations of 25(OH)D2 and 3-epi-25(OH)D3.

Precision and accuracy of commercial assays for vancomycin therapeutic drug monitoring: evaluation based on external quality assessment scheme

2020 ◽  
Author(s):  
Chao-Yang Chen ◽  
Meng-Ya Li ◽  
Ling-Yun Ma ◽  
Xing-Yu Zhai ◽  
Dao-Huang Luo ◽  
...  
Keyword(s):  
Serum Concentration ◽  
Quality Assessment ◽  
Bacterial Infections ◽  
External Quality Assessment ◽  
Detection Methods ◽  
Therapeutic Drug ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Percentage Difference ◽  
Precision And Accuracy

Abstract Background Vancomycin remains a mainstay of the treatment of Gram-positive bacterial infections. It is crucial to accurately determine vancomycin serum concentration for adequate dose adjustment. Objectives To evaluate the precision and accuracy of commercial assay techniques for vancomycin concentration and to assess the comparability of vancomycin detection methods in Chinese laboratories. Methods Human serum samples spiked with known concentrations of vancomycin were provided to laboratories participating in the external quality assessment scheme (EQAS). Assay methods included chemiluminescence, enzyme immunoassay (EIA) and so on. The dispersion of the measurements was analysed and the robust coefficient of variation (rCV), relative percentage difference (RPD) and satisfactory rate for method groups were calculated. Moreover, performance of the Chinese laboratories was assessed. Results A total of 657 results from 75 laboratories were collected, including 84 samples from 10 Chinese laboratories. The median rCV, median RPD and satisfactory rates classified by methods ranged from 1.85% to 15.87%, −14.75% to 13.34% and 94.59% to 100.00%, respectively. Significant differences were seen in precision, between kinetic interaction of microparticles in solution (KIMS) and other methods, and in accuracy, between enzyme-multiplied immunoassay technique (EMIT), fluorescence polarization immunoassay (FPIA) and other techniques. Vancomycin detection in China mainly depended on the chemiluminescence and EMIT methods, which tended to result in lower measurements. Conclusions Although almost all assays in this study achieved an acceptable performance for vancomycin serum concentration monitoring, obvious inconsistencies between methods were still observed. Chinese laboratories were more likely to underestimate vancomycin concentrations. Thus, recognizing inconsistencies between methods and regular participation in vancomycin EQAS are essential.

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