mtsa journal cover

*ONLINE ONLY * OPEN ACCESS*

 
MOST RECENT ARTICLES

Peer reviewed ORIGINAL ARTICLE
Open Access

Phase II: Development Phase – Laboratory Strengthening
Assessment of In vitro Diagnostic Device acquisition processes within NHLS

S Moodliar | Dr D Basu
Published online: July 2018

| PDF |
Background: The National Health Laboratory Services (NHLS), Quality Assurance (QA) department’s responsibility is to ensure diagnostic supplies meet required standards. Of particular importance are in vitro diagnostic devices (IVD’s) such as: reagents, all controls including Quality Controls (QC), equipment and laboratory consumables. Applying the required standards ensures that they are ‘fit for purpose’. This process supports and enhances laboratory accreditation as well as strengthening all laboratory systems.
Objectives: To assess: (i) the IVD’s acquisition processes within the NHLS; (ii) whether a health technology assessment (HTA) framework could be used and (iii) assessing the impact of implementing a health technology assessment unit in supporting accreditation and strengthening laboratory systems.
Methods: The researchers planned a strategy meeting to review IVD acquisition processes within the selected organisation. The participants were multidisciplinary technical laboratory personal. The discussions at the HTA strategic workshop focused on Quality Assurance and laboratory accreditation in addressing the requirements of ISO15189:2012, which is important to ensure consistent adherence to accreditation and compliance measures across all the laboratories within the NHLS framework.
Results: A workshop entitled: Health Technology Assessment Strategy was the first workshop held by the NHLS to stress the challenges faced when acquiring new technologies. The workshop participant’s described the present processes of IVD acquisition within the NHLS as incoherent. In particular, they emphasised the lack of clearly defined IVD evaluation and requisition procedures. The examples given were the following: the adoption of technologies on ad-hoc bases with limited consensus from all users, the lack or inadequate selection criteria for performance evaluations, the need to adopt standardised protocols and report templates and the absence of a national database to ensure monitoring and compliance of existing suppliers.
Conclusions: The acquisition of IVD’s for pathology services is a universal requirement. The NHLS is unique as it provides pathology services to hospitals but is not incorporated as part of the hospital’s management system. However the impact of evaluating IVD’s is a requirement for developed and developing countries. The establishment of the HTA unit would provide an environment for the coordination and management all IVD requests. This unit would be a single port of entry at the NHLS for all IVD performance evaluations and in addition it would support laboratory accreditation as well as procurement decision making processes within the NHLS.

Peer reviewed ORIGINAL ARTICLE
Open Access

Phase III: Capacity phase
An influx of In vitro Diagnostic Devices – how to address current challenges?

S Moodliar | Dr D Basu
Published online: July 2018

| PDF |
Background: The Health Technology Assessment (HTA) unit was established in 2012, under the auspices of the Quality Assurance Department at the National Health Laboratory services (NHLS) to address the national accreditation needs by supporting laboratory accreditation.
Objectives: The global trend to address the burden of disease has led to an increase in the availability of Health Technology (HT). The influx of in vitro diagnostic (IVD) medical devices poses a challenge to the diagnostic pathology laboratories in adopting a selection criterion for procurement. This paper describes the current IVD medical device procurement system within the NHLS and how the influx of medical devices can be managed.
Methods: Review of the organisation procurement processes; planning a strategic workshop to understand current IVD challenges within the organisation; implementation of laboratory staff training on HTA principles, practices and policy processes. Enable the drafting of a HTA policy and HT guideline documents.
Results: The review of the procurement processes identified gaps in the areas of planning and needs assessment; commissioning, installation and monitoring of medical devices. The strategic workshop and HTA training presented the laboratories with current challenges regarding the influx of new technologies and deviations in medical device evaluation processes. The HTA Policy Forum finalised the HTA policy and the four guideline documents to address current organisational challenges and how to adopt Hospital-Based Health Technology Management (HB-HTM).
Conclusion: This review enabled the organisation to initialise the HTA programme by harmonising and standardising current processes and creating the HTA unit as a single point of entry within the organisation for all new health technologies.

Peer reviewed ORIGINAL ARTICLE
Open Access

Evaluation of antimicrobial activity using Artemisia afra, Psidium guajava and Erythrina lysistemon on Staphylococcus species
NW Nsele | S Moodley
Published online: July 2018

| PDF |
Background: Medicinal plants contain components of therapeutic value and provide an alternative form of available antibiotics to multiple infections. Development of microbial resistance to the available antibiotics has further enhanced the investigation of the role of antimicrobial activity of medicinal plants.
Method: Here we report the antimicrobial properties of Artemisia afra, Psidium guajava and Erythrina lysistemon extracts obtained by using two different extraction solvents. Extracts were subjected to tests using zones of inhibition, Thin Layer Chromatography and High Pressure Liquid Chromatography (HPLC).
Results: Pronounced antimicrobial activity was observed against Staphylococcus aureus using the ethanol extraction technique. However, no statistical significance was observed between the results produced using extracts from both methods A (according to dilution factor) and B (method 3a of the German Homeopathic Pharmacopoeia).
Conclusion: The potential for developing antimicrobials from plants in vivo provides a platform for phytomedicine and pharmacological studies.

Peer reviewed ORIGINAL ARTICLE
Open Access

HbA1c enzymatic assay evaluation at AN academic laboratory
B Phiri-Ramongane
Published online: July 2018

| PDF |
Background: HbA1c is a well-known and widely accepted marker for monitoring glycaemic control in patients with Diabetes Mellitus. It has also been shown to predict long term microvascular complications associated with Diabetes Mellitus. As a result the International Expert Committee has endorsed HbA1c as a diagnostic marker for Diabetes Mellitus. There are several assays available for the measurement of HbA1c and the recommended assay performance is an intralaboratory coefficient of variation of <2%.
The aim of the study was to evaluate the analytical performance of the HbA1c enzymatic assay on the Abbott Architect ci8200.
Method: The precision, reportable range and bias were determined by following The Clinical and Laboratory Standards Institute (CLSI) EP05, EP06 and EP15 guidelines. Bias was determined by comparison between the Abbott Architect and the Biorad
Variant II analyser.
Results: The total impresicion for low and high controls was 1.06% and 1.8% respectively. The assay demonstrated excellent correlation with the Biorad Variant II analyser with a slope of 0.923, intercept of 0.569 and R2 of 0.978. The Bland-Altman mean difference was 0.044 between the Abbott Architect and Biorad Variant II analysers. At the diagnostic and monitoring cut-off, the
bias was found to be 1.05% and 0.43% respectively.
Conclusion: The new enzymatic HbA1c assay demonstrated good precision and had the advantage of rapid analysis thus prompt results reporting. The study also demonstrated acceptable agreement of the Abbott Architect and Bio-Rad Variant II methods across the measured range. Notably, the assay met analytical goals for the diagnosis and monitoring of Diabetes Mellitus using, as the total allowable error was 1.13% and 1.03% respectively, which was well below the 3% total allowable recommended error from biological data.

Peer reviewed ORIGINAL ARTICLE
Open Access

Customised Critical Limits Help to Achieve Efficient Use of the Laboratory’s Resources
Dr E Schapkaitz | Dr M Engelbrecht | T Mogoregi
Published online: July 2018

| PDF |
Background: Customisation of critical value policies in laboratories with increasing workloads helps to achieve efficient use of laboratory’s resources.
Methods: The critical value policy at an academic hospital was customised with the introduction of a new middleware (Sysmex Corporation, Kobe, Japan). The number of notifications over a one-month period was reviewed in order to determine the impact of customisation on laboratory resources and patient safety.
Results: 1891 haematology critical values were identified. 1195 (63%) results did not require notification according to the customised policy. Of these, 1034 (55%) had a previous critical result, 89 (5%) were not phoned as per customer request and in 72 (4%) the critical result was already viewed by the clinician.
Conclusion: Customisation resulted in a marked reduction in the critical results requiring notification. Laboratory information system middleware can be developed to consider factors such as, a change in the current result from previous results, patient location and requesting doctor to customise notification.

Peer reviewed ORIGINAL ARTICLE
Open Access

T-cell Activation And Dysfunction in Hyperglycaemia
MT Nyambuya | GM Davison | GM Hon | AP Kengne | RT Erasmus | TE Matsha
Published online: July 2018

| PDF |
Although controversial, hyperglycaemia has been associated with immune dysregulation. We compared the expression of T-cell activation markers in Western Cape hyperglycaemic individuals with matched normoglycaemic controls. Sixty nine participants (86% being women) were included and screened for hyperglycaemia according to World Health Organisation (WHO) criteria. Standard multi-colour flow cytometry was used to measure expression of HLA-DR, CD38, CD95 and PD-1on T-cells at baseline and post incubation with 30mmol glucose. The results were compared and correlated with markers of glucose metabolism and inflammation. The 69 participants included 35 with normal glucose tolerance and 34 with hyperglycaemia. Antigen expression was similar between the two groups. However, after exposure to glucose the percentage of CD4+ T-cells expressing CD95 significantly decreased (p=0.03). There was no correlation with markers of glucose metabolism, but expression did correlate with C-reactive protein. This study in a modest sample group found no relationship between T-cell activation and glucose metabolism, suggesting that other factors such as obesity may be responsible for immune dysregulation. Further studies are required to confirm these findings.


back to the top