Screening of drugs of abuse in urine has been routinely used for many years, but has not been validated in Nyaope use which is a mixture of various groups of addictive drugs, stabilizers and other materials. One hundred current Nyaope users were recruited from two large townships in the northern suburbs of Pretoria, South Africa and six Nyaope samples were purchased from drug dealers in the same townships. Blood tests were done to exclude liver and kidney dysfunctions. Fresh urine samples were collected from the participants with normal functions and relevant information was obtained by standard questionnaire with the assistance of a nurse and a public health worker. Urine screening using Alere iCUPs tested 12 drugs of abuse with immediate results. Adulteration and urine quality checks were built-in as part of the test. Not all the constituents found in Nyaope were detected in the urine. Codeine, Hydrocodone, Papaverine were negative and Oxycodone was low positive in some samples. Cannabis was not always detected and depended on how Nyaope was consumed. Paracetamol, Caffeine, Dextromethorphan were not tested. In conclusion, Urine rapid screening tests for DOA cannot differentiate between single drug use and Nyaope (mixture) use and this has implications in treatment programmes.
There is increasing evidence that extremely low frequency (ELF) electromagnetic fields (EMFs) interact with immune cells. Even more evident is that immune cells are activated when exposed to these fields for a short period. Signal specificity and dosimetry appear to play a role. In this study, four groups of laboratory mice received daily exposure to a specific electromagnetic field with an intensity of 5µT for one hour, four hours and twenty-four hours (continuously) respectively for a period of seven days. The control group received no exposure and was used as standard for comparison. Following exposure, whole blood was analysed for leukocyte count, CD3, CD4, CD8 and CD19 analysis. The results for the twenty-four hour exposure group indicated increased total leukocyte, lymphocyte, CD3 and CD4 values and a decreased neutrophil values. These findings provide evidence that the immune system is indeed stimulated by exposure to EMFs.
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.
Nyaope is a novel psychoactive mixture of drugs unique to South Africa’s townships. A mixture of caffeine, paracetamol, opiates, sedatives, psychoactive drugs as well as antibiotics and antiretroviral drugs were identified using Time of Flight Mass Spectrometry. The Nyaope users frequently complained of severe chest and abdominal pain, excessive drowsiness, vomiting and diarrhoea with progressive weight loss. However, the effect of Nyaope on various body systems has not been verified. The purpose of this study was to investigate the status of liver, kidney, endocrine function, and haematological parameters in chronic Nyaope users. Ninety eight users participated for laboratory analyses of liver, kidney, thyroid and gonadal functions, blood counts and immunophenotyping. From these, 86.7% of users showed abnormalities in the laboratory tests performed, and 10.2% to 31.6% with possible specific organ dysfunctions. In conclusion, Nyaope users were found to have abnormal laboratory parameters that may be suggestive of organ dysfunctions, occult infections, and possible bone marrow suppression and would require further investigations.
Background: The automated fragmented red cell (FRC) is a promising diagnostic tool for the rapid diagnosis of patients with a suspected thrombotic micro-angiopathy (TMA). Aim: To evaluate the FRC in comparison to the microscopic schistocyte percentage in order to determine its diagnostic utility. Methods: Schistocytes were evaluated in 136 samples by microscopy by two competent morphologists according to International Council for Standardisation in Haematology (ICSH) recommendations. This was compared with the FRC on the Sysmex XN-9000 (Sysmex Corporation, Kobe, Japan). The degree of agreement was measured using the Bland and Altman method and Deming-regression statistical methods. Results: Schistocytes were observed in patients with TMA (8.82%), malignancies (11.03%), haemodialysis (34.56%), haemoglobinopathies (8.82%), nutritional anaemias (13.24%) and in neonates (1.47%). The correlation co-efficient between the two morphologists was 0.97 (CI, 0.92 to 1.01) and the mean of the differences was -0.02 (CI, -0.53 to 0.50). The Sysmex overestimated the schistocyte count (2.61, CI, 2.15 to 3.07) and revealed a poor correlation with microscopy (0.21 CI, 0.05 to 0.38). There was no correlation between the percentage of microcytic (%Micro-R) and hypochromic red cells (%Hypo-He) and the FRC. Conclusion: This study confirms that observer bias between morphologists can be reduced by implementing the ICSH guidelines. Measurement of the automated FRC by the Sysmex XN 9000 analyser overestimated the schistocyte percentage. The FRC requires confirmation by microscopy.
Background: Research indicates an increase in drug resistance to pathogenic human bacteria, despite the increase in synthetic antimicrobial drugs. As a result, medicinal plants are proving to be rich resources of constituents which can be used in drug development and synthesis of antimicrobial agents and/or their derivatives. Many of therapeutic drugs e.g. antimicrobial, anti-cancer and antioxidants have compounds extracted from plants as their primary active ingredients or molecules of plant origin serve as blue prints for synthetic or partially synthetic drugs. Methods: The antimicrobial activity of the Asparagus laricinus aqueous extract was evaluated by determination of minimum inhibitory concentration against laboratory strains of both gram-positive ( Bacillus subtilis , Streptococcus pneumonia and Staphylococcus aureus ) and gram-negative bacteria ( Pseudomonas aeruginosa , Escherichia coli and Proteus vulgaris ). The micro-plate assays based on iodo-nitrotetrazolium violet indicator was used to evaluate cell viability. Antioxidative stress activity of the extract was determined using Saccharomyces cerevisiae (BY4742) as the model eukaryotic system, while constitutes of the plant extract were profiled using LC/MS. Results: This study reports on the anti-bacterial and antioxidative stress activity of Asparagus laricinus . It was observed that 50µg/ml of the plant extract was the (MIC) for the gram-positive bacteria Bacillus subtilis , Streptococcus pneumonia and Staphylococcus aureus . While100µg/ml that was required for other gram-negative strains, Pseudomonas aeruginosa , Escherichia coli and Proteus vulgaris and Staphylococcus aureus was inhibited by 25µg/ml of the plant extract. The plant extract protected Saccharomycescerevisiae (BY4742) cells from oxidative stress when the cells were incubated with 10mM (H 2 O 2 ) for 1.5 hours. The phyto constituents of the plant extract were profiled using LC/MS and four major peaks were assigned chemical formulae. Conclusions: Asparagus laricinus water extract showed antimicrobial and antioxidative stress activities. LC/MS profile of major constituents of the plant extract revealed the presence of an alkaloid similar to 4-thiazolidinones, known to have important biological activities.
There are frequent requests for duo paternity tests thus increasing the possibility of false paternity inclusions. The aim of this study was to identify possible false inclusions when comparing the duo to the trio paternity profile to see if there is a discrepancy in the results when using 15-loci autosomal short tandem repeat (STR) analysis. We concluded that wrongful inclusions would have occurred in duo paternity profiles in three cases out of 240 trio exclusions. Paternity probabilities between 95.0688215064% and 99.99964871% were calculated on the duos. We demonstrated how duo results were changed from an inclusion to a definite exclusion when the mother’s DNA profile was added to the test, showing the importance of the mother’s profile in paternity testing and the risk of false inclusions in duo cases. These findings support the literature where false inclusions are reported in a paternity test where the mother’s profile is omitted, as well as the recommendation for 3 or more mismatches as an exclusion criterion.
Lesotho faces a catastrophic syndemic of HIV and tuberculosis (TB). In 2011, the government of Lesotho launched isoniazid preventive therapy (IPT) as a once-off intervention to reduce the occurrence of TB in HIV-positive people. This study evaluated the effectiveness of IPT and the durability of its effectiveness based on Cox’s proportional hazards regression analysis of 2 955 records randomly sampled from six districts of Lesotho. The overall TB incidence rate was 2.0 per 100 person-years in 12 208 person-years. Thirty-nine (15.9%, n=246) patients developed TB after IPT. TB incidences per 100 person-years by timing of IPT were as follows: (a) IPT before ART (1.7); (b) IPT after ART (1.8); (c) no IPT (2.6); (d) IPT within one year of ART commencement (1.3) and (e) IPT 3-5 years after ART initiation (2.3). Gender, baseline World Health Organisation (WHO) clinical staging, district category and time to IPT relative to ART commencement emerged as significant predictors of TB occurrence. Increasing time to IPT by one six-month interval increased the risk of contracting TB by between 6% and 59. Further, IPT effectiveness rapidly deteriorated after four years. This indicates that delayed IPT after ART commencement significantly affects the effectiveness of this intervention. The need to consider booster doses of IPT cannot be overemphasised.
Introduction: The frequency of serious bacterial infections has increased due to the high prevalence of HIV, contributing to the increasing rates of multi-drug organisms which include carbapenem-resistant Enterobacteriaceae (CRE). This has resulted in higher use of immunosuppressive and cytotoxic drugs to treat serious bacterial infections and optimal treatment for infections caused by CRE remains unknown. The benefits of azole antifungals and its derivatives have become very topical due to their diverse spectrum of pharmacological properties, but its efficacy has not been tested in the South African context. The aim of this study was to determine the antibacterial effects of azole antifungals against CRE. Method: Different concentrations of azole antifungals (ketoconazole, metronidazole and fluconazole) were used to prepare sensitivity discs and four pathogenic strains of CRE ( K. pneumoniae, E. coli, S. marcesens and C. freundii ). These were obtained from Lancet Laboratory in Durban and were used to determine the antibacterial activity of the selected azole antifungals, using: Disc Diffusion, Modified Agar Diffusion and Minimum Inhibition Concentration (MIC) method, as described by Bauer et al. 1966. Results: Antimicrobial Susceptibility Testing revealed that azoles have no inhibition activity against CRE test organisms and biochemical tests also demonstrated that azoles have no adverse effects on the CRE organisms. Conclusion: Although the results obtained in this study indicated no activity of azoles against CRE, clinical studies are still necessary for the modification of the azole substituents and synthesis of azole derived drugs to confirm and optimise the antibacterial efficacy of these compounds.
Background: Unavailability of pyruvate quantification at the majority of the National Health Laboratory Service (NHLS) laboratories in South Africa prevents patient’s access to a lactate-to-pyruvate ratio (L:P ratio) determination. Thus the diagnosis and prognosis of hypoxemic conditions can be compromised. To obtain the ratio, lactate is measured; either using heparinised blood with a blood gas analyser as a point of care test (POCT) or in a sodium fluoride (NaF)/ potassium oxalate plasma on an automated laboratory analyser. Measurement of pyruvate concentrations in serum are offered at certain referral laboratories using a manual method and requires pre-packedclot enhanced serum tube (red top) with perchloric acid (PCA). The use of two different types of samples and additional sample preparation for L:P ratio is inconvenient for the patient, clinicians and alsoposes a risk for pre-analytical errors. This study aimed to determine if two tests can be consolidated in one NaF plasma tube whilst maintaining the perchlorate de-proteinisation to preserve pyruvate. Objectives: To compare pyruvate concentrations in the serum and plasma (anticoagulant: NaF) samples using a UV/visible spectrophotometer to assess the validity of using plasma for pyruvate analysis. Methods: Fifty patients with high whole blood lactate concentrations using a point of care analyzer at the Intensive Care Unit (ICU) were included in the study. Twenty-five specimens from a health control group were also included. Pyruvate was measured in perchloric acid treated serum and plasma samples using a UV/Visible spectrophotometer. The results of both types of samples were compared in both patient and control groups. Results: In the patient group, a correlation coefficient of R 2 between plasma and serum pyruvate results was 0.35 while in the control group was 0.36 demonstrating poor correlation. The mean of the serum pyruvate concentrations in the patient group was 0.151 mmol/L, and in the plasma samples was 0.065 mmol/L with P=0.00. The mean pyruvate concentration in the serum samples of the control group was 0.108 mmol/L and in the plasma samples was 0.041 mmol/L with the P value of 0.01. The mean percentage difference between the plasma and serum pyruvate of the patient group was 51% and that of the control group was 60% both of which are above the within individual biological variation (15.2%) as well as the reference change value (RCV) or critical difference for pyruvate (47%). The recovery percentage of the pyruvate on plasma was below the acceptable range (80-120%). Conclusion: There was a significant under-estimation of pyruvate in plasma compared to serum samples in both the patient and control groups and the mean percentage difference is beyond the within subject biological variation of pyruvate for clinical use. Thus the use of NaF plasma for pyruvate determination is not recommended.
The Universitas Hospital NHLS Laboratory received a query from a paediatrician regarding the “delayed” laboratory results for baby H, a 1-month-old infant. The laboratory had received nine specimens from that same unit but none for baby H. Upon investigation, using standard laboratory procedures of checking traceability and delta-checking of consecutive chemistry test results over a few days, results were found for a baby whose blood had not been sampled that day (baby M). Review of baby M’s results appeared to better match the clinical findings of baby H mainly because he was jaundiced (on phototherapy) and baby H was not. A further complication was that 10 sample collection tubes had been pre-labelled in preparation for the phlebotomy procedure. However, because blood had not been collected from baby M there was the added possibility of a serial error in sample-patient linking in 8 of the remaining 9 samples. Most laboratory errors occur in the pre-analytical phase, and many of these involve mislabelling of specimen tubes. Morning group pre-labelling is a common Universitas hospital practice prior to actual phlebotomy and is designed to speed up the sample collection process, so that results are available in time for the morning consultant ward round. This report serves to act as an alert of the possible dangers of serial error and possible disastrous effect on patient care.
As such, medical technology, serves the purpose of seeking to enhance the quality of human life. In recent times, the effects of societal and ethical as well as legal aspects of technologies in medicine have come under the spotlight. Clinicians invariably use a wide assortment of technologies within the spectrum of laboratory medicine in diagnosing, treating and assessing the care of patients. These assortments of technologies play a pivotal role in healthcare and one could argue that medical practice is now fundamentally dependent on these technologies. While medical technology should be reducing the overall cost of treating patients due to its ability to enhance prevention by deriving custom-made therapies, this is not the case. Medical technology is conversely becoming more expensive, and as it is use increases, so does the cost of healthcare for patients at all levels of the socio-economic spectrum. The increasing use of high-end technology is very expensive, thereby increasing the cost of for example, laboratory testing. These ever increasing costs are beyond the reach of the average South African citizen who cannot afford the exorbitant costs of medical aid. This article addresses the ethicality of what is seemingly an unjust practice. It asserts that there should be greater efforts not only by the industry to develop suitable affordable technologies, but also by the various pathology laboratory sectors in accordance with the various medical needs and priorities of South African society. The local healthcare market is undergoing substantial cost constraints. If any new offerings are to be adopted by all healthcare providers, they first need to validate the cost in contrast to the assessable improvement such offerings can provide to improve or stabilise patient healthcare. The ever increasing cost of healthcare is unaffordable for the majority of South African citizens. All this can be construed as unethical practice since it increases medical costs for other citizens, as medical aid schemes are obliged to pass on these exorbitant costs incurred by them, to their members.
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.
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.
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.
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.
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.
The biggest healthcare funders in South Africa are the South African Government and medical aid schemes and they operate in a highly-regulated environment. Unfortunately, the pervasiveness of healthcare fraud concerning collusion between medical aid members and healthcare providers such as physicians is swelling. Health care fraud is invariably a method of white collar crime that could be carried out by a number of stakeholders, inter alia , health care providers, customers, firms providing medical goods or services, and also health care organizations such as medical aid schemes. This article introduces the South African healthcare sector, the numerous ethical challenges for the healthcare providers and the notion of ethics education. The objective of this article is thus even in small measure, to seek to instil a positive ethical mind-set in all medical practitioners and health sector employees. It seeks to support industry initiatives to reduce fraud and ethical misconduct, and offers ethical guidance to practitioners and medical aid schemes and proposes a Medical Practitioner Ethical Guidelines Framework.
Background : A study was conducted in South Africa on the performances of Intern Medical Technologists related to the National Board examinations. For the past decade, concerns have been raised regarding the high failure rates for Interns in these Board examinations. Objective : This study aimed at identifying possible reasons for the high failure rates in the four main disciplines in the National Board examination for Biomedical Technology being: Clinical pathology, Haematology, Chemical Pathology and Microbiology. Method : Quantitative and qualitative data were triangulated to investigate the pass rates of Interns writing these examinations. The National Board examination results were analysed for statistical significant differences using the ANOVA and the Pearson Chi-square test. The key role players involved in the Internship training of Interns at training laboratories and examinations of Interns were asked to complete a survey regarding the quality and adequacy of training offered by training facilities. Results : Statistical data from the analysis confirmed that the pass rates were extremely poor and from the data of the surveys, possible reasons for this were identified. Conclusion : This study added invaluable information to a broad dimension of problems related to education and training of Medical technologists. Recommendations and suggestions on how to improve these pass rates are conversed.
Objectives: In South Africa, the introduction of the Medical and Related Substances Act R. 586 has focused more attention on the role of medical devices in health care. The objectives of this study were: a) to explore how the introduction of Health Technology Assessment (HTA) of in vitro diagnostic devices (IVD) can optimise the National Health Laboratory Service’s (NHLS’s) diagnostic test budget and b) increase test coverage to the public sector. Methods: A literature search was conducted using multiple databases to understand how the assessment and management of Health Technology (HT) is conducted in established HTA organisations. In particular key searches were in vitro diagnostic medical devices. The study was limited to HTA organisations involved with Health Technology including all those who have adopted a Health Technology Management (HTM) system for medical devices. In particular, key searches included the annotation: in vitro diagnostic medical devices. Results: The NHLS is the largest pathology service in the world. The decisions made in the diagnostic environment of NHLS can be compared to hospital based HTA. The literature review provided an overview of factors enabling the NHLS to determine whether new health technologies should be adopted. Those included, whether decision processes were appropriate, how to evaluate the methodology for IVD evaluations and how to assess factors likely to influence decisions and suggestions for current process improvement. Conclusion: Improved decision making on the acquisition of new health technologies in pathology services through the use of the HTA framework can help reduce IVD acquisition expenditure. This will help in alleviating the ongoing cost of healthcare and allow present and future substantiality to be maintained.
