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 Mapping the coverage, availability and uptake of External Quality Assessment programmes across One Health sectors in Asia

2021 ◽  
Author(s):  
Ondari D Mogeni ◽  
Freshwork Ayalew Abegaz ◽  
Jong-Hoon Kim ◽  
Hea Sun Joh ◽  
Vicky Gaedt Kastbjerg ◽  
...  
Keyword(s):  
Quality Assessment ◽  
One Health ◽  
External Quality Assessment ◽  
External Quality ◽  
Laboratory Surveillance ◽  
Readiness Level ◽  
Support Mechanisms ◽  
Eqa Schemes

Abstract Introduction Establishing effective external quality assessment (EQA) programmes is an important element in ensuring the quality of, and building capacity for, antimicrobial resistance (AMR) laboratory surveillance. Objectives To understand the current coverage of, and challenges to participation in, EQAs in National Reference Laboratories (NRLs) across One Health (OH) sectors in Asia. Methods Current EQA coverage was evaluated through desktop review, online surveys and interviews of both EQA participants and providers. EQA coverage was mapped and summarized by laboratory type and ‘readiness’ level and identified challenges evaluated qualitatively. Results Of the 31 identified NRLs [16 Human Health (HH) and 15 Animal/Food Safety laboratories (A/FS)], 14 HH and 7 A/FS laboratories currently participated in international EQA schemes and several participated in two or more different schemes. Seven laboratories were currently not participating in any EQA scheme and two of these (one HH and one A/FS) do not currently perform microbiology; six HH NRLs provided national EQAs. Of the eight surveyed international EQA providers, three were based in Asia and all offered varying programmes in terms of pathogens, frequency and support mechanisms for reporting and follow-up. Only one provider currently served laboratories across all OH sectors. Conclusions The current coverage of EQA programmes for AMR in Asia was heterogeneous across countries but especially across OH sectors. This updated overview of the coverage and challenges associated with participation in, and provision of, EQAs for AMR suggest the benefit and relevance of introducing one comprehensive and high-quality EQA programme across OH sectors in Asia.

External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Deborah A. Payne ◽  
Graciela Russomando ◽  
Mark W. Linder ◽  
Katarina Baluchova ◽  
Tester Ashavaid ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
Alternative Assessment ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Molecular Diagnostic ◽  
Internal Quality ◽  
External Quality ◽  
Iso 15189 ◽  
Eqa Schemes

AbstractObjectivesQuality management for clinical laboratories requires the establishment of internal procedures including standard operating procedures (SOPs), internal quality control (QC), validation of test results and quality assessment. External quality assessment (EQA) and alternativeassessment procedures (AAPs) are part of the quality hierarchy required for diagnostic testing. The International Organization for Standardization (ISO) document with requirements for conformance ISO 15189 and the Clinical and Laboratory Standards Institute document (CLSI) QMS24 require participation in EQA schemes and AAPs where applicable. The purpose of this study was to perform a global survey of EQA and AAPs for key procedures in molecular diagnostic laboratories.MethodsThe Committee for Molecular Diagnostics of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) conducted a survey of international molecular laboratories that covered specific topics of molecular diagnostic services as well as methods for EQA and AAPs. The survey addressed the following aspects: (1) usage of laboratory-developed test (LDT), (2) participation in EQA schemes and (3) performance of AAPs.ResultsA total of 93 responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. The majority of the participating laboratories (65.9%) use LDTs and 81.3% stated that it is mandatory for them to participate in EQA programs, while 22% of the laboratories reported not performing AAPs. Thirty-one percent of the laboratories use EQAs for fewer than 50.0% of their reported parameters/analytes.ConclusionsWhile the majority of laboratories perform EQA and AAPs to improve their quality in molecular diagnostics, the amount of AAPs as quality procedures differs within the laboratories. Further surveys are necessary to clarify the existing needs in additional EQAs and standardized AAPs. The survey will also guide future efforts of the IFCC C-MD for identifying quality practices in need to improve harmonization and standardization within molecular diagnostics.

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 Results of the UK NEQAS for Molecular Genetics reference sample analysis

2018 ◽  
Vol 71 (11) ◽  
pp. 989-994 ◽  
Author(s):  
Susan D Richman ◽  
Jennifer Fairley ◽  
Jacqueline A Hall ◽  
Nakul Nataraj ◽  
Mrudul Bhide ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Genetics ◽  
External Quality Assessment ◽  
Single Gene ◽  
Reference Sample ◽  
Human Cell Line ◽  
External Quality ◽  
Gene Testing ◽  
Variant Frequency ◽  
Eqa Schemes

AimsIn addition to providing external quality assessment (EQA) schemes, United Kingdom National External Quality Assessment service (UK NEQAS) for Molecular Genetics also supports the education of laboratories. As an enhancement to the Molecular Pathology EQA scheme, a human cell-line reference sample, manufactured by Thermo Fisher Scientific (AcroMetrix), was provided for analysis. This contained many variants, present at frequencies between 1% and 17.9%.MethodsOne hundred and one laboratories submitted results, with a total of 2889 test results on 53 genes being reported. Known polymorphisms, 46/2889 (1.59%) results, were excluded. Variants detected in the seven most commonly reported (and clinically relevant) genes, KRAS, NRAS, BRAF, EGFR, PIK3CA, KIT and PDGFRA, are reported here, as these genes fall within the scope of UK NEQAS EQA schemes.ResultsNext generation sequencing (NGS) was the most commonly performed testing platform. There were between 5 and 27 validated variants in the seven genes reported here. Eight laboratories correctly reported all five NRAS variants, and two correctly reported all eight BRAF variants. The validated mean variant frequency was lower than that determined by participating laboratories, with single-gene testing methodologies showing less variation in estimated frequencies than NGS platforms. Laboratories were more likely to correctly identify clinically relevant variants.ConclusionsOver 100 laboratories took the opportunity to test the ‘educational reference sample’, showing a willingness to further validate their testing platforms. While it was encouraging to see that the most widely reported variants were those which should be included in routine testing panels, reporting of variants was potentially open to interpretation, thus clarity is still required on whether laboratories selectively reported variants, by either clinical relevance or variant frequency.

Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys

2015 ◽  
Vol 53 (10) ◽  
Author(s):  
James O. Westgard ◽  
Sten A. Westgard
Keyword(s):  
Quality Assessment ◽  
Proficiency Testing ◽  
External Quality Assessment ◽  
Objective Assessment ◽  
Analytical Quality ◽  
External Quality ◽  
Proficiency Assessment ◽  
Laboratory Examinations ◽  
Intended Use

AbstractThere is a need to assess the quality being achieved for laboratory examinations that are being utilized to support evidence-based clinical guidelines. Application of Six Sigma concepts and metrics can provide an objective assessment of the current analytical quality of different examination procedures.A “Sigma Proficiency Assessment Chart” can be constructed for data obtained from proficiency testing and external quality assessment surveys to evaluate the observed imprecision and bias of method subgroups and determine quality on the Sigma scale.Data for hemoglobin AAssessment of quality on the Sigma scale provides evidence of the analytical performance that is being achieved relative to requirements for intended use and should be useful for identifying and prioritizing improvements that are needed in the analytical quality of laboratory examinations. In spite of global and national standardization programs, bias is still a critical limitation of current HbA

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