The implementation of an external quality assurance method for point- of- care tests for HIV and syphilis in Tanzania

It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

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Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2014-0483 ◽

2015 ◽

Vol 53 (1) ◽

Cited By ~ 4

Author(s):

Tone Bukve ◽

Thomas Røraas ◽

Berit Oddny Riksheim ◽

Nina Gade Christensen ◽

Sverre Sandberg

Keyword(s):

General Practice ◽

Quality Assurance ◽

Point Of Care ◽

External Quality Assurance ◽

Initial Assessment ◽

Internal Quality ◽

Feedback Report ◽

Analytical Quality ◽

External Quality ◽

Urine Albumin

AbstractThe Norwegian Quality Improvement of Primary Care Laboratories (Noklus) offers external quality assurance (EQA) schemes (EQASs) for urine albumin (UA) annually. This study analyzed the EQA results to determine how the analytical quality of UA analysis in general practice (GP) offices developed between 1998 (n=473) and 2012 (n=1160).Two EQA urine samples were distributed yearly to the participants by mail. The participants measured the UA of each sample and returned the results together with information about their instrument, the profession and number of employees at the office, frequency of internal quality control (IQC), and number of analyses per month. In the feedback report, they received an assessment of their analytical performance.The number of years that the GP office had participated in Noklus was inversely related to the percentage of “poor” results for quantitative but not semiquantitative instruments. The analytical quality improved for participants using quantitative instruments who received an initial assessment of “poor” and who subsequently changed their instrument. Participants using reagents that had expired or were within 3 months of the expiration date performed worse than those using reagents that were expiring in more than 3 months.Continuous participation in the Noklus program improved the performance of quantitative UA analyses at GP offices. This is probably in part attributable to the complete Noklus quality system, whereby in addition to participating in EQAS, participants are visited by laboratory consultants who examine their procedures and provide practical advice and education regarding the use of different instruments.

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Essential aspects of external quality assurance for point-of-care testing

Biochemia Medica ◽

10.11613/bm.2017.010 ◽

2017 ◽

pp. 81-85 ◽

Cited By ~ 5

Author(s):

Anne Stavelin ◽

Sverre Sandberg

Keyword(s):

Quality Assurance ◽

Point Of Care ◽

External Quality Assurance ◽

Point Of Care Testing ◽

External Quality

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Performance of Afinion HbA1c measurements in general practice as judged by external quality assurance data

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2019-0879 ◽

2020 ◽

Vol 58 (4) ◽

pp. 588-596

Author(s):

Anne Stavelin ◽

Kristine Flesche ◽

Mette Tollaanes ◽

Nina Gade Christensen ◽

Sverre Sandberg

Keyword(s):

Diabetes Mellitus ◽

Quality Assurance ◽

Point Of Care ◽

Analytical Performance ◽

External Quality Assurance ◽

Pass Rates ◽

Total Quality ◽

External Quality ◽

Performance Specification ◽

Performance Specifications

AbstractBackgroundIt has been debated whether point-of care (POC) glycated hemoglobin (HbA1c) measurements methods can be used for diagnosing persons with diabetes mellitus. The aim of this study was to evaluate the analytical performance of the POC Afinion HbA1c system in the hands of the users, and to investigate which predictors that were associated with good participant performance.MethodsExternal quality assurance (EQA) data from seven surveys in 2017–2018 with a total of 5809 Afinion participants from a POC total quality system in Norway were included in this study (response rate 90%). The control materials were freshly drawn pooled EDTA whole blood. Each participant was evaluated against the analytical performance specification of ±6% from the target value, while the Afinion system was evaluated against the pooled within-laboratory CV <2%, the between-laboratory CV <3.5%, and bias <0.3%HbA1c. Logistic regression analyses were used to investigate which factors were associated with good participant performance.ResultsThe participant pass rates for each survey varied from 98.2% to 99.7%. The pooled within-laboratory CV varied from 1.3% to 1.5%, the between-laboratory CV varied from 1.5% to 2.1%, and bias varied between −0.17 and −0.01 %HbA1c in all surveys. Reagent lot was the only independent factor to predict good participant performance.ConclusionsAfinion HbA1c fulfilled the analytical performance specifications and is robust in the hands of the users. It can therefore be used both in diagnosing and monitoring persons with diabetes mellitus, given that the instrument is monitored by an EQA system.

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The Importance of Reagent Lot Registration in External Quality Assurance/Proficiency Testing Schemes

Clinical Chemistry ◽

10.1373/clinchem.2015.247585 ◽

2016 ◽

Vol 62 (5) ◽

pp. 708-715 ◽

Cited By ~ 12

Author(s):

Anne Stavelin ◽

Berit Oddny Riksheim ◽

Nina Gade Christensen ◽

Sverre Sandberg

Keyword(s):

Quality Assurance ◽

Proficiency Testing ◽

Point Of Care ◽

International Normalized Ratio ◽

External Quality Assurance ◽

External Quality ◽

Albumin Creatinine Ratio ◽

Proficiency Testing Schemes ◽

Urine Albumin ◽

Eqa Schemes

Abstract BACKGROUND Providers of external quality assurance (EQA)/proficiency testing schemes have traditionally focused on evaluation of measurement procedures and participant performance and little attention has been given to reagent lot variation. The aim of the present study was to show the importance of reagent lot registration and evaluation in EQA schemes. METHODS Results from the Noklus (Norwegian Quality Improvement of Primary Care Laboratories) urine albumin/creatinine ratio (ACR) and prothrombin time international normalized ratio (INR) point-of-care EQA schemes from 2009–2015 were used as examples in this study. RESULTS The between-participant CV for Afinion ACR increased from 6%–7% to 11% in 3 consecutive surveys. This increase was caused by differences between albumin reagent lots that were also observed when fresh urine samples were used. For the INR scheme, the CoaguChek INR results increased with the production date of the reagent lots, with reagent lot medians increasing from 2.0 to 2.5 INR and from 2.7 to 3.3 INR (from the oldest to the newest reagent lot) for 2 control levels, respectively. These differences in lot medians were not observed when native patient samples were used. CONCLUSIONS Presenting results from different reagent lots in EQA feedback reports can give helpful information to the participants that may explain their deviant EQA results. Information regarding whether the reagent lot differences found in the schemes can affect patient samples is important and should be communicated to the participants as well as to the manufacturers. EQA providers should consider registering and evaluating results from reagent lots.

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