Overview

Diagnosis of a disease typically includes testing of patient samples on an appropriate diagnostic platform, and it is necessary to perform proficiency testing of these platforms regularly, so as to assure the accuracy of the results,  Professor Kana and his team at Wits have developed proficiency testing controls required for verification of tests on first use of the diagnostic platform, as well as ongoing External Quality Assurance (EQA) programs. Prof Kana’s unique approach is targeted at molecular diagnostics, specifically for platforms detecting TB, SARS-COV-2, HIV, Hepatitis C-virus (HCV) and methicillin-resistant Staphylococcus aureus (MRSA) infection. The biomimicry approach allows the team to genetically engineer a safe, fast-growing bacterium to effectively “mimic” the bacteria or virus for which the diagnostic test is conducted.

Bacterial and viral infectious diseases are diagnosed by either culturing the infecting agent from clinical specimens or by detecting a molecule that is unique to the infecting agent, the latter commonly referred to as molecular diagnostics. Ideally, one would use the infecting agent as a positive control for the proficiency test, but this can pose a significant biological risk to laboratory staff. In the case of airborne respiratory infections such as tuberculosis (TB) and the SARS-CoV-2 infection, the problem is particularly acute as use of these infectious agents as controls to validate tests can result in widespread infections amongst lab staff, and into their respective communities.  

The biomimicry approach to creating controls effectively mitigates all these concerns as it allows the engineering of any target, from any infectious disease agent. This has resulted in the creation of controls for numerous disease targets, such as those mentioned, and thus providing safer, easier to manufacture proficiency testing controls, whilst ensuring the level of confidence in the testing platforms is maximised.

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