scholarly journals External quality assessment program for biochemical assays of human seminal plasma: a French 6-years experience

2020 ◽  
Vol 30 (1) ◽  
Author(s):  
Safouane M. Hamdi ◽  
Erick Sanchez ◽  
Delphine Garimbay ◽  
Stéphanie Albarede
Keyword(s):  
Quality Assessment ◽  
Seminal Plasma ◽  
External Quality Assessment ◽  
Prostatic Acid Phosphatase ◽  
Seminal Vesicles ◽  
Human Seminal Plasma ◽  
External Quality ◽  
Iso 15189 ◽  
Accessory Glands ◽  
Health Authorities

Abstract Background In 1999, despite a longstanding use, the WHO manual for the examination of human semen finally proposed to assay several biochemical components of the seminal plasma for a functional exploration of the male accessory glands. At the same time, an international effort was made to standardize laboratory tests and to increase their performance through ISO 15189 accreditation. In this setting, participation to relevant external quality assessment (EQA) schemes is an essential requirement for laboratories. To fulfil this injunction, we have organized an EQA program for seminal biochemistry using presumed commutable samples. In this study, we aimed to report an overview of the French laboratory offer, the kinds of assays used, their performance as well as their likelihood of satisfying ISO15189 requirements for EQA. Results Between 2014 and 2019, we performed seven surveys. A median of six laboratories participated to each survey giving a ratio of one laboratory per 11.2 million inhabitants. Seven biomarkers are routinely assayed but the core set shared by all laboratories comprised citrate and zinc (prostate), fructose (seminal vesicles) and α-1, 4 glucosidase (epididymis). The use of CE-IVD marked methods concerned between 0 to 75% of overall assays. According to analytical specifications, 100% of laboratories results were compliant for zinc, 75% for citrate and α-1,4 glucosidase and 67% for fructose. By combining overall data in an empirical scoring system, we identified several types of seminal biomarkers: citrate, fructose and zinc appear as good candidates for a full accreditation, α-1,4 glucosidase still presents an analytical weakness, but prostatic acid phosphatase, free L-carnitine and glycerophosphocholine cannot be accredited in the current state. Conclusions We organized the first French EQA program for seminal biochemistry to help local laboratories to face their legal requirement to be fully accredited by 2020. It could be improved still further but it gave us an oversight on the analytic landscape. Effective methods are available for a confident biochemical exploration of prostate and seminal vesicles. However, that of epididymis appeared unexpectedly fragile. This andrological issue should be addressed by dedicated recommendations from health authorities and scientific societies.

scholarly journals Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Laura Sciacovelli ◽  
Andrea Padoan ◽  
Sandra Secchiero ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
High Standard ◽  
Medical Laboratory ◽  
Data Sets ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Analytical Procedures ◽  
Medical Laboratory Professionals

Abstract Objectives Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. Methods All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. Results A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Conclusions Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements.

scholarly journals External quality assessment programs in the context of ISO 15189 accreditation

2018 ◽  
Vol 56 (10) ◽  
pp. 1644-1654 ◽  
Author(s):  
Laura Sciacovelli ◽  
Sandra Secchiero ◽  
Andrea Padoan ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
Specific Activity ◽  
External Quality Assessment ◽  
International Standards ◽  
Fundamental Importance ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Clinical Laboratories ◽  
The Right

Abstract Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

scholarly journals An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

2017 ◽  
Vol 55 (11) ◽  
Author(s):  
Andrea Padoan ◽  
Giorgia Antonelli ◽  
Ada Aita ◽  
Laura Sciacovelli ◽  
Mario Plebani
Keyword(s):  
Quality Control ◽  
Measurement Uncertainty ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Internal Quality ◽  
Test Results ◽  
External Quality ◽  
Iso 15189 ◽  
Medical Laboratories

AbstractBackground:The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).Methods:The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.Results:A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.Conclusions:The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria

2018 ◽  
Vol 56 (12) ◽  
pp. 2039-2046 ◽  
Author(s):  
Christoph Buchta ◽  
Wim Coucke ◽  
Wolfgang R. Mayr ◽  
Mathias M. Müller ◽  
Reinhard Oeser ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Quality Management System ◽  
External Quality Assessment ◽  
Positive Impact ◽  
Error Rates ◽  
Iso 9001 ◽  
Quality Systems ◽  
External Quality ◽  
Laboratory Performance ◽  
Iso 15189

Abstract Background ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services. Although widely used, their impact on laboratory performance has not been investigated. Methods We retrospectively analysed the results of 167 laboratories in 59 distributions of the Austrian red cell immunohaematology external quality assessment (EQA) scheme in the years 1999–2017. The performance for each parameter and trends of individual participants were compared with respect to certification or accreditation status of participants’ quality systems and to laboratory type. Results Considering more than 52,000 EQA results, the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p=0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%). Conclusions Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results. The conclusion is that these results apply to other laboratory tests and perhaps to other areas of health care.

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.

Human Epididymis Protein 4 Quantification and Interaction Network Analysis in Seminal Plasma

2019 ◽  
Vol 26 (6) ◽  
pp. 458-465
Author(s):  
Krishna Kant ◽  
Anil K. Tomar ◽  
Pankaj Sharma ◽  
Bishwajit Kundu ◽  
Sarman Singh ◽  
...  
Keyword(s):  
Seminal Plasma ◽  
Binding Proteins ◽  
Interaction Network ◽  
Prostatic Acid Phosphatase ◽  
Regulatory Subunit ◽  
Plasma Samples ◽  
Human Seminal Plasma ◽  
Human Epididymis Protein 4 ◽  
Human Epididymis ◽  
Core Proteins

Background: A well-known tissue marker of ovarian cancer, Human Epididymis protein 4 (HE4) is the member of whey acidic four-disulfide core proteins family. Purified from human seminal plasma and characterized as a cross-class protease inhibitor, HE4 was proposed to shield spermatozoa against proteolytic factors. However, its exact biological function is unknown. Proteins usually function in conjunction with other proteins in the system and thus, identification and analysis of protein networks become essential to decode protein functions. Objective: This study was performed to explore possible role(s) of HE4 in reproductive physiology via identification of its interactome in human seminal plasma. Methods: HE4 binding proteins were identified through co-immunoprecipitation and MALDITOF/ MS analysis. Also, HE4 was quantified by ELISA in fertile and infertile human seminal plasma samples. Results: Ten HE4 binding proteins were identified, viz. protein phosphatase 1 regulatory subunit 21, protein kinase CLK3, Ankyrin repeat domain-containing protein36A, prostatic acid phosphatase, KIF5C, Spectrin repeat containing, nuclear envelope 1, isoform CRAf, tropomyosin 4, vezatin, utrophin and fibronectin1. This interaction network suggests that HE4 plays multiple roles, specifically in capacitation, sperm motility and maturation. Further, HE4 concentration in human seminal plasma samples was determined by Elisa. Higher HE4 expression in normozoospermia compared to azoospermia and asthenozoospermia affirms its importance in fertilization. Conclusion: Based on identified interactome, it is plausible that HE4 plays a crucial role in fertilization, specifically in sperm maturation, motility and capacitation.

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