Test Tubes

About Us

Since the onset of widescale molecular testing for TB in 2010, SmartSpot has been developing controls to meet the quality needs of TB molecular laboratories across the globe.

 

SmartSpot Quality is a South African based private company which started in 2010 as a research program at the Department of Molecular Medicine and Haematology (DMMH) and the Centre of Excellence for Biomedical TB Research (CBTBR) at the University of Witwatersrand. Global demand for the SmartSpot controls required scaled up production and as such the University registered SmartSpot Quality (Pty) Limited as a company to execute this role.  SmartSpot has been granted an exclusive license to the patented technology and the University departments have continued to improve the technology as well as adapt it to develop controls for additional diseases.

 

In 10 years, SmartSpot has developed a global footprint in 30 countries providing Ministries of Health, Clinical Trial Units and private laboratories with quality control solutions. SmartSpot is the largest commercial supplier of molecular TB controls and provides a companion diagnostic for qualifying the accuracy of molecular diagnostic tests including TB, HIV, SARS-CoV-2, and soon MRSA and HCV.

 

Company History

In 2010, Professors Wendy Stevens and Lesley Scott of the Department of Molecular Medicine and Haemetology at the University of Witwatersrand created a companion diagnostic to ensure that new molecular TB Diagnostic machinery being implemented in the field is “fit for purpose” and externally quality assessed. After months of applying great science and thinking out of the box, the dry culture spot (DCS) for MTB/RIF was borne.

 

Over the next 5 years, in collaboration with Professor Bavesh Kana and his team at the Centre of Excellence for Biomedical TB Research (University of Witwatersrand) the product was developed, tested, rolled out through South Africa National Health Laboratory Services to 282 sites and then endorsed by the World Health Organisation for verification of the GeneXpert instrument for TB testing. Subsequently the uptake of the TB DCS program was significant (391 sites in 24 countries) and the need arose to spin off a company from the research program in order to ensure the scalability of the service as well as the continued research and development required to expand the DCS program to other infectious diseases such as HIV, HPV and more to come.

 

The spin off company is SmartSpot Quality (Pty) Ltd. The design, manufacture and support of the TB DCS and other programs continue with an expanded team of passionate employees committed to empowering laboratories and diagnostic manufacturers to save lives and uplift communities. 

 

The team has won several awards for its ingenuity including the Innovation Prize for Africa’s Social Impact Award 2015, the GAP Biosciences Business Plan Award 2014 for biotechnology entrepreneurship and the NHLS National Innovation award in 2013.

Articles

Genetic Mimetics of Mycobacterium
tuberculosis and Methicillin-Resistant
Staphylococcus aureus as Verification
Standards for Molecular Diagnostics

Performance Monitoring of Mycobacterium tuberculosis Dried Culture Spots for Use with the GeneXpert System within a National Program in South Africa

Multicenter Feasibility Study To Assess External Quality Assessment Panels for Xpert MTB/RIF Assay in South Africa

A Pilot Evaluation of External Quality Assessment of GenoType
MTBDRplus Versions 1 and 2 Using Dried Culture Spot Material

Dried Culture Spots for Xpert MTB/RIF External Quality Assessment: Results of a Phase 1 Pilot Study in South Africa

Awards

Winner of the NHLS National Innovation Award (2013)

Winner of the GAP BioSciences Award (2014)

Winner of Innovation Prize for Africa 2015 – Social Impact Award

Partnerships

Adopted by Abbott Molecular and Hain LifeSciences.

Working with Bruker-Hain and Cepheid to develop QC for new XDR. Assays

WHO replaces their product with SmartSpot, and endorses it for MTB verification on GeneXpert (2012).

Formed a partnership with Cepheid to purchase in bulk and deliver controls with all new instruments.

Contributions

Awarded US patent April 2014

5 peer reviewed manuscripts, ~10 conferences

Development of Controls for HIV VL, EID and HCV across platforms.

Clinical trial uptake: AIDS Clinical Trial Group in 13 Countries  

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