A National Laboratory Perspective: The Impact of the Covid-19 Pandemic on the Management of Patients With Non-Communicable Disease in South Africa: Impact of COVID-19 on patients with noncommunicable diseases.

OBJECTIVE: The aim of this study was to determine the impact of the COVID-19 pandemic on test requests for the diagnosis and routine care of patients with various non-communicable diseases (NCD) across South Africa (SA). METHODS: A retrospective audit of laboratory test requests received from hospital outpatient departments and primary healthcare facilities across SA was performed. The following analytes were studied: glycated hemoglobin (HbA1c), lipids profiles, thyroid-stimulating hormone (TSH), and thyroxine (fT4), as well as triiodothyronine (fT3), serum protein electrophoresis (SPE), serum free light chains (SFLC), and prostate specific antigen (PSA); these tests were used as a proxy of NCD detection and follow-up. Requests received during the 3 waves of the pandemic were compared to requests received within the same period during 2017 - 2019. RESULTS: During the first wave, requests for all analytes were reduced, with the biggest reduction observed for SPE (- 37%); TSH (- 29%); fT4 (- 28%); and HbA1c (- 25%). Requests received from urban facilities showed a larger decrease compared to those from rural facilities. During the third wave there was an increase in requests for all analytes; the biggest increase observed was for fT3 (21%) and HbA1c (18%). CONCLUSIONS: The COVID-19 pandemic had a significant impact on the South African population receiving care in the public healthcare sector.

Copeptin analysis in endocrine disorders.

Copeptin is cleaved from the same precursor as arginine vasopressin and is released in equimolar amounts with arginine vasopressin from the posterior pituitary in response to the same stimuli. Its level of stability in the blood, quick and simple analysis, and ease of automation make it much easier to analyze than arginine vasopressin, thereby offering a suitable alternative to measuring arginine vasopressin in endocrine disorders. Research has demonstrated the suitability of copeptin in adults for the differentiation of arginine vasopressin resistance and arginine vasopressin deficiency from primary polydipsia, in addition to the early identification of arginine vasopressin deficiency following pituitary surgery; however, further research is still required in the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) and the pediatric population.

Evaluation of tumour marker utilisation and impact of electronic gatekeeping in the province of KwaZulu-Natal, South Africa.

Background: Inappropriate testing remains a high healthcare cost driver. Tumour marker tests are more expensive than routine chemistry testing. Implementing test demand management systems like electronic gatekeeping (EGK) has reportedly decreased test requests. Objective: This study aimed to describe the appropriateness of tumour marker tests, carcinoembryonic antigen, alpha foetal protein, prostate-specific antigen, carbohydrate antigen 19-9, cancer antigen 15-3, cancer antigen 125, and human chorionic gonadotropin, and determine the effectiveness of the EGK used in the public health sector in KwaZulu-Natal, South Africa. Methods: Tumour marker test data for the KwaZulu-Natal province were extracted from the National Health Laboratory Service Central Data Warehouse for 01 January 2017 - 30 June 2017 (pre-EGK) and 01 January 2018 - 30 June 2018 (post-EGK implementation). Questionnaires were sent to the clinicians in the regional hospitals ordering the most tumour marker tests to assess ordering practices. In addition, we assessed monthly rejection reports to determine the effect of the EGK. Results: The EGK minimally reduced tumour marker requests or associated costs (1.4% average EGK rejection rate). An overall 18% increase in the tumour marker tests occurred in 2018. The data suggest inappropriate tumour marker test utilisation, particularly for screening. Conclusion: The introduction of EGK as a test demand management had little impact on tumour marker test requests and costs. Continuous education and reiteration of indications for tumour marker test use are required. What this study adds: This study demonstrates the ineffectiveness of EGK in tumour marker orders, and provides some insight as to why these markers are being ordered, which is important in trying to decrease inappropriate ordering of these tests.

Assessment of Sigma Metrics for Routine Chemistry Testing in 4 Laboratories in Kwa-Zulu Natal, South Africa.

BACKGROUND: Sigma metrics is a quantitative management tool. This study assessed the Six Sigma score for 26 chemistry analytes, compared scores with different total allowable errors (TEa) and use of scores for internal quality control (IQC) rules in 4 Laboratories in Kwa-Zulu Natal, South Africa. METHODS: Utilizing 6 months of IQC SD, CV, and bias data on albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, bicarbonate, calcium, total cholesterol, creatine kinase, chloride, creatinine, gamma glutamyl transferase, glucose, HDL-cholesterol, potassium, lactate dehydrogenase, magnesium, sodium, inorganic phosphate, direct bilirubin, total bilirubin, triglycerides, total protein, urea nitrogen, uric acid, and C-reactive protein (CRP) Six Sigma scores were calculated using Microsoft Excel 2016 and ideal IQC rules were determined. Six Sigma scores using Ricos et al. 2014, Royal College of Pathologists Australasia, and Clinical Laboratory Improvement Amendments TEas were compared. RESULTS: For levels 1, 2, and 3 respectively, analytes scoring >3 sigma was 9 (35%), 12 (46%), and 14 (54%) in Laboratory A; Laboratory B had 15 (58%), 19 (73%), and 17 (65%); Laboratory C had 12 (46%), 13 (50%), and 15 (58%); and Laboratory D had 13 (50%), 18 (69%), and 18 (69%). Albumin, calcium, sodium, magnesium, bicarbonate, and chloride scored <3; CRP scored >6 for all. In Laboratories A, B, C, and D, 7 (27%), 7 (27%), 6 (23%), and 8 (31%) analytes, respectively, required only 1 IQC rule. One of 21 analytes for Laboratories C and D, 3 for Laboratory A, and 0 for Laboratory B had the same sigma score with all 3 databases. CONCLUSION: Despite South Africa being a developing nation, many analytes are able to achieve >3 sigma.

Evaluation of the CKD-EPI creatinine based glomerular filtration rate estimating equation in Black African and Indian adults in KwaZulu-Natal, South Africa.

BACKGROUND: The estimation of glomerular filtration rate (GFR) plays a vital role in assessment of the renal function. This study evaluated the performance of the CKD-EPIcreat and MDRD equations in the South African Kwa-Zulu Natal population. OBJECTIVES: The objectives if the study were to compare the of CKD-EPIcreat and MDRD equations in the selected population to the measured GFR using Sodium Technetium-99 m-diethylene-triamine-pentaacetate clearance derived GFR. METHOD: Records of adult patients with measured GFR performed at the Nuclear Medicine Department at Inkosi Albert Luthuli Central Hospital, Durban, South Africa from 1 April 2014 to 31 March 2016 were reviewed. eGFR for all included patients was calculated using the MDRD equation without African American correction factor and the CKD-EPIcreat equation with and without the African American correction factor for the Black African patients. Statistical comparison of the eGFR with measured GFR was performed with Bland Altman bias plots, Wilcoxon match pairs signed ranks test and accuracy within 10% and 30%.ROC curve analysis assessed the sensitivity and specificity at eGFR <90 and < 60 ml/min/1.73m2. RESULTS: After exclusion, 287 patients were included for analysis with sufficient numbers for only the Black African and Indian patients. None of the equations showed accuracy of eGFR within 30% of measured GFR for 90% of patients. In the Black African population, the CKD-EPIcreat equation without the correction factor performed best. 17% and 14.4% of the Black African participants would be reclassified with the CKD-EPIcreat equation without and with the African American correction factor respectively compared to mGFR at a cut-off of 60 mls/min/1.73m2. CONCLUSION: None of the evaluated equations attained the 2002 KDOQI benchmark of P30 >90%. 11.1-17% of individuals would have been incorrectly classified using the CKD-EPIcreat equation.

Historical perspectives in clinical pathology: a history of glucose measurement.

This is the second in the series of historical articles dealing with developments in clinical pathology. As one of the most commonly measured analytes in pathology, the assessment of glucose dates back to the time of the ancient Egyptians. It was only in the 19th century that advances in chemistry led to the identification of the sugar in urine being glucose. The following century witnessed the development of more chemical and enzymatic methods which became incorporated into the modern analysers and point-of-care instruments which are as ubiquitous as the modern day cellphones. Tracking the milestones in these developments shows the striking paradigms and the many parallels in the development of other clinical chemistry methods.