Analytical performance specifications based on how clinicians use laboratory tests. Experiences from a post-analytical external quality assessment programme

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
Geir Thue ◽  
Sverre Sandberg
Keyword(s):  
Primary Care ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Analytical Performance ◽  
Case Histories ◽  
External Quality ◽  
Assessment Programme ◽  
Erythrocyte Sedimentation ◽  
Performance Specifications

AbstractAnalytical performance specifications can be based on three different models: the effect of analytical performance on clinical outcome, based on components of biological variation of the measurand or based on state-of-the-art. Models 1 and 3 may to some degree be combined by using case histories presented to a large number of clinicians. The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) has integrated vignettes in its external quality assessment programme since 1991, focusing on typical clinical situations in primary care. Haemoglobin, erythrocyte sedimentation rate (ESR), HbA

Evaluation of the ARKRAY HA-8190V instrument for HbA1c

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Eline A.E. van der Hagen ◽  
Sanne Leppink ◽  
Karin Bokkers ◽  
Carla Siebelder ◽  
Cas W. Weykamp
Keyword(s):  
Quality Assessment ◽  
Concentration Level ◽  
External Quality Assessment ◽  
Clinical Samples ◽  
Diabetic Patients ◽  
External Quality ◽  
Target Values ◽  
Performance Specifications ◽  
Certification Programme ◽  
And Performance

Abstract Objectives Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument. Methods The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated. Results The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of −0.1 mmol/mol (−0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of −1.0 and 0.9 mmol/mol (−2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias −0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP). Conclusions Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.

scholarly journals Most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants – results from the QCMD 2013 N. gonorrhoeae external quality assessment programme

2014 ◽  
Vol 19 (8) ◽  
Author(s):  
D Luijt ◽  
C Di Lorenzo ◽  
A M van Loon ◽  
M Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Molecular Diagnostic ◽  
External Quality ◽  
Diagnostic Assays ◽  
Assessment Programme ◽  
Negative Results ◽  
False Negative Results

We describe the results of the Quality Control for Molecular Diagnostics 2013 Neisseria gonorrhoeae external quality assessment programme that included an N. gonorrhoeae strain harbouring an N. meningitidis porA gene which causes false-negative results in molecular diagnostic assays targeting the gonococcal porA pseudogene. Enhanced awareness of the international transmission of such gonococcal strains is needed to avoid false-negative results in both in-house and commercial molecular diagnostic assays used in laboratories worldwide, but particularly in Europe.

scholarly journals Accuracy of HbA1c as Monitored by External Quality Assessment and Compared With Patient Mean Values

2018 ◽  
Vol 12 (4) ◽  
pp. 771-779 ◽  
Author(s):  
Gunnar Nordin
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Small Variation ◽  
Specific Method ◽  
External Quality ◽  
Swedish Population ◽  
Mean Values ◽  
Hba1c Test ◽  
Performance Specifications

Background: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. Methods: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. Results: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. Conclusions: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.

External quality assessment in primary health care by using fresh whole blood

1994 ◽  
Vol 40 (12) ◽  
pp. 2223-2226 ◽  
Author(s):  
E Raabo ◽  
L Odum
Keyword(s):  
Primary Care ◽  
Quality Assessment ◽  
Whole Blood ◽  
Room Temperature ◽  
Matrix Effects ◽  
External Quality Assessment ◽  
Single Test ◽  
Control Material ◽  
External Quality ◽  
Primary Health

Abstract Desktop analyzers and single-test meters used in primary healthcare are mainly calibrated to measure whole blood. To minimize matrix effects of control materials in external quality assessment schemes, we stabilized fresh human EDTA-treated blood with sodium iodoacetate (1.8 mmol/L). The whole-blood based control material was useful for control of hemoglobin and glucose, the two most common analyses in primary care, even after storage at room temperature for at least 10 days and at 5 degrees C for 3 weeks. The material was also useful for control of cholesterol and creatinine analyses for samples stored as long as 3 days at ambient temperature.

Findings of an external quality assessment scheme for determining aluminum in dialysis fluids and water

1994 ◽  
Vol 40 (8) ◽  
pp. 1517-1521 ◽  
Author(s):  
A Taylor ◽  
R J Briggs ◽  
C Cevik
Keyword(s):  
Quality Assessment ◽  
Reference Materials ◽  
Significant Influence ◽  
Matrix Effects ◽  
External Quality Assessment ◽  
Analytical Performance ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Dialysis Fluids

Abstract The analytical performance of laboratories participating in the dialysis fluids and water aluminum program of the Guildford External Quality Assessment Scheme over the period 1986-1993 has been reviewed. For aluminum concentrations > 3.33 mumol/L in dialysis fluids, the between-laboratory CV has fallen from approximately 36% to 23%, whereas for specimens of water the reduction was from 36% to approximately 18%. Improvements at lower concentrations were less impressive. Performance of individual participants varied; only a few consistently provided accurate results. Many of the participants are able to measure serum aluminum well, so lack of expertise is not responsible for poor results. We suggest that matrix effects associated with different specimen types have a significant influence on performance and that due account is not always taken of these factors. Resolution of these problems would be aided by appropriate reference materials.

scholarly journals The WHO AFRO external quality assessment programme (EQAP): Linking laboratory networks through EQA programmes

2016 ◽  
Vol 5 (2) ◽  
Author(s):  
Debrah I. Boeras ◽  
Rosanna W. Peeling ◽  
Philip Onyebujoh ◽  
Ali A. Yahaya ◽  
Hieronyma N. Gumede-Moeletsi ◽  
...  
Keyword(s):  
Public Health ◽  
Quality Management ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Quality Standards ◽  
World Health ◽  
Public Health Importance ◽  
External Quality ◽  
Assessment Programme

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of publichealth microbiology laboratories, particularly for testing of epidemic-prone diseases in theAfrican Region. These surveys revealed common issues such as supply chain managementskilled personnel, logistical support and overall lack of quality standards. For sustainableimprovements to health systems as well as global health security, deficiencies identified needto be actively corrected through robust quality assurance programmes and implementation oflaboratory quality management systems.Given all the pathogens of public health importance, an external quality assessment programmewith a focus on vaccine-preventable diseases and emerging and re-emerging dangerouspathogens is important, and should not be stand-alone, but integrated within laboratorynetworks as seen in polio, measles, yellow fever and rubella.In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Preventionthe London School of Hygiene & Tropical Medicine and partners in a series of consultationswith countries and national and regional EQA providers for the development of qualityassurance models to support HIV point-of-care testing and monitoring. These consultationsrevealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forthits experience in implementing quality standards for health programmes, and also openeddiscussions on how lessons learned through such established programmes can be utilised tosupporting and strengthening the introduction of early infant diagnosis of HIV and viralload point-of-care testing.An optimised external quality assessment programme will impact the ability of countries tomeet core capacities, providing improved quality management systems, improving theconfidence of diagnostic network services in Africa, and including capacities to detect eventsof international public health importance.

Sign in / Sign up

Export Citation Format

Share Document