Quality assurance for point-of-care testing: Ethiopia’s experience

Context.— The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non–Indigenous Australians. If chronic kidney disease is detected early and managed, deterioration in kidney function can be reduced. Urine albumin to creatinine ratio is a key marker of early renal damage. Objective.— To report on 16 years of analytic quality of urine albumin to creatinine ratio testing on Siemens DCA devices enrolled in the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services point-of-care testing program. Design.— Quality Assurance for Aboriginal and Torres Strait Islander Medical Services participants are required to test 2 quality assurance samples each month across two 6-monthly testing cycles per year. Participants also test 2 quality control samples monthly. Results.— The percentage of urine albumin, creatinine, and albumin to creatinine ratio results for quality assurance point-of-care testing that were within assigned allowable limits of performance averaged 96.9%, 95.9%, and 97.5%, respectively. The percentage acceptable quality control results for urine albumin and creatinine averaged 93.5% and 86.8%. The median imprecision for urine albumin, creatinine, and albumin to creatinine ratio quality assurance testing averaged 5.5%, 4.1%, and 3.3%, respectively, and the median within-site imprecision for quality control testing averaged 5.4%, 4.3%, and 5.7%, respectively, for the low sample and 4.0%, 4.1%, and 4.5%, respectively, for the high sample. Conclusions.— For 16 years the DCA system has proven to be reliable and robust and operators at Aboriginal medical services have demonstrated they are able to conduct point-of-care testing for urine albumin to creatinine ratio that consistently meets analytic performance standards.

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External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

African Journal of Laboratory Medicine ◽

10.4102/ajlm.v5i2.556 ◽

2016 ◽

Vol 5 (2) ◽

Cited By ~ 4

Author(s):

Debrah I. Boeras ◽

Rosanna W. Peeling

Keyword(s):

Quality Assurance ◽

Point Of Care ◽

Lessons Learned ◽

Tropical Medicine ◽

External Quality Assurance ◽

Laboratory Diagnostics ◽

London School ◽

Point Of Care Testing ◽

External Quality ◽

Resource Limited

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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Evaluation of the Hemochron Junior Signature Analyser for Oral Anticoagulant Point of Care Testing.

Blood ◽

10.1182/blood.v108.11.4109.4109 ◽

2006 ◽

Vol 108 (11) ◽

pp. 4109-4109

Author(s):

Peter H. Bogo ◽

Jamie Maddox ◽

Ewan McGregor ◽

Jayne McKay ◽

Anne Bancroft ◽

...

Keyword(s):

Quality Assurance ◽

Lower Limit ◽

Correction Factor ◽

Oral Anticoagulant ◽

Point Of Care ◽

Mean Difference ◽

Laboratory Evaluation ◽

Rabbit Brain ◽

Point Of Care Testing ◽

Upper Limit

Abstract The community anticoagulant service in Tayside, Scotland provides point of care testing for around 5000 patients at 25 sites using 43 analysers. Since December 2004 this service has used the Hemochron Junior Signature (HJS) analyser (International Technidyne Corporation) for INR measurement. Following satisfactory initial laboratory evaluation, we have compared results of capillary samples analysed using the HJS to venous samples collected simultaneously and analysed in Ninewells Hospital using a Sysmex CA1500 analyser. Reagents used were Citrate PT test cuvettes (International Technidyne Corporation) which uses rabbit brain thromboplastin for the HJS and Dade Innovin (Dade Behring) for the CA1500. Samples for comparison were collected randomly from approximately every tenth patient tested in the anticoagulant clinics for a 12 month period. Results of the comparison are given for 3 separate periods within the 12 months of study as ongoing analysis of data during the study period led to the introduction of a correction factor for results obtained using the HJS analyser. The first correction factor was introduced after the first 4 weeks of study and there was a subsequent revision of this correction factor after a further 5 months. Results for these 3 periods are as follows (all results given are INR units). Period 1: Mean INR 2.8 CA 1500 vs. 3.8 HJS, mean difference −1.0, 95% upper limit of agreement 0.5, 95% lower limit of agreement −2.5 (n=145). Period 2: Mean INR 2.6 CA 1500 vs. 2.7 HJS, mean difference −0.1, 95% upper limit of agreement 1.1, 95% lower limit of agreement −1.2 (n=345). Period 3: Mean INR 2.7 CA 1500 vs. 2.8 HJS, mean difference 0.0, 95% upper limit of agreement 1.3, 95% lower limit of agreement −1.3 (n=662). Additionally, local external quality assurance was performed on 13 occasions (683 total tests) during the period of study. Cumulative results demonstrate that 86% of results were within 15% of the median. We have demonstrated an approach to quality assurance for oral anticoagulant point of care testing and conclude that the HJS is a suitable analyser for this purpose.

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