Specialised Diagnostic Products South Africa


The Evolution of Specialised Diagnostic Products used in South Africa

It was only during the ‘50s that diagnostic efforts began to rely less exclusively upon physical examination. Before that, physicians demonstrated relatively little dependence on the results of laboratory tests and the plethora of specialised products that have since become so widely used in South Africa today simply did not exist. Since those early days, an entire industry devoted to the development of test procedures, reagents and technologies for use in routine medicine and research has emerged and its evolution has taken two main directions – tests for use in the pathology or medical research laboratories and those for use at the point of care.

Among the earliest of these test kits to emerge were those developed by the joint efforts of the Ames and Miles companies, and included Clinitest tablets for the detection and rough quantitation of glucose in urine. The test employed Benedict’s copper sulphate reagent in an exothermic reaction that made boiling unnecessary and could be used either in the laboratory or a consulting room. Later developments saw products such as Albustix and Ketostix – absorbent strips impregnated with suitable reagents for the detection of albumin and ketones in urine respectively. These, in turn, led to specialised diagnostic products capable of detecting multiple substances in a single sample while yet another development saw approximate blood glucose measurements conducted in a similar fashion.

Although, in South Africa and many other countries, tests such as these are still in use today, new technologies have continued to open up far greater possibilities with test kits that are more specific, that are more reliable, that are helping to make the task of technologists, nurses and physicians a lot easier and, most importantly, that are providing the means for early diagnoses that is so essential to patient treatment and survival.

Some of the most significant advances in the development of specialised diagnostic products to have taken place in recent years lie within the field of oncology. In South Africa, as in most countries, the incidence of malignancies among the population has been increasing steadily and the need for new methods to detect them, and procedures to treat them has become an urgent priority.

Some of the most significant advances in this area have been the result of efforts by the innovative German company Schebo Biotech AG. More specifically, these take the form of rapid screening tests for use in the differential diagnosis of pancreatic dysfunction and the detection of colorectal cancer.

Both tests make use of enzyme-linked immunosorbent assays (ELISA) in order to detect and to quantitate various monoclonal antibodies in body fluids. The first of these specialised diagnostic products targets the enzyme pancreatic elastase 1 and provides a non-invasive means to identify or exclude insufficiencies. The other is used to detect the enzyme biomarker known as M2-PK and provides a highly sensitive method with which to identify colorectal cancer even in the absence of a positive occult blood result which, until now, was the main screening test for this condition.

In South Africa, IEPSA has long been an industry leader and the nation’s preferred supplier of high-quality, state-of-the-art test kits, analytical instruments, consumables and disposables for use in the nation’s clinical and medical research laboratories as well as at the point of care. 



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