Our specialization

SmartSpot Quality is a companion diagnostic for qualifying the accuracy of molecular TB diagnostic tests. SmartSpot has developed a patented technology that enables us to safely package inactivated Mycobacterium tuberculosis on a simple spot on a card which is easily and safely tested like a patient’s clinical specimen. Each card weighs less than 3g and is easy, safe and cost effective to transport, as well as being stable for more than 12 months at ambient temperatures. SmartSpot is compatible on many molecular TB testing platforms.

SmartSpot Quality is a South African grown company which started in 2010. In 6 years, SmartSpot has developed a global footprint in 24 countries and is utilised in 391 sites around the world with many more countries in the pipeline.

In South Africa, SmartSpot has been used on all 289 instruments in the National TB program. Over the duration of a year, SmartSpot cost ~0.1% of the cost of the South African national TB screening program and the results of the testing found that 2.6% of the instrument’s modules on installation required additional maintenance before tests could be performed on clinical specimens.

 

If SmartSpot was not used, this could have translated to 78,000 test results of the 3million tests performed having been in error. The harsh impact of this could have been that some patients may have remained undiagnosed and either have died or spread the disease within their communities. Others could have been incorrectly diagnosed with TB and put onto 18 months of toxic drugs which may lead to hearing loss among other negative side effects.

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Number of Spots distributed globally
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Global Expansion : SmartSpot Quality Sites
    • South Africa – NHLS since 2011 and now expanded to Correctional Services and peri-mining (mobile)
    • Namibia Pathology CDC
    • Swaziland CDC
    • Malawi, Kenya, Zambia, Tanzania, Zimbabwe, Uganda, Botswana, Ghana, Nigeria, Senegal

Verification

Instrument verification involves testing standardized material on a diagnostic instrument to ensure that it is ‘fit-for-purpose’ before clinical specimens can be tested. Verification should be performed on each GeneXpert module upon:

  • Instrument installation
  • Module replacement
  • If an instrument is moved
  • Post Cartridge calibration
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EQA

EQA is used to ensure on-going quality monitoring of diagnostics, from pre- to post-analytical processing. The SmartSpot Quality EQA product is offered three times/year/instrument. Each EQA panel comprises 4 DCS (combinations of M.tb Rif sensitive, M.tb Rif resistant; NTM; negative).

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Products and services

SmartSpot Quality’s flagship product is for molecular TB. SmartSpot for TB is manufactured using Mycobacterium tuberculosis and nontuberculosis mycobacterium grown in a single cell format, chemically and heat-inactivated, quantified and spotted onto perforated cards. SmartSpot is available as single spot cards for EQA (3x a year) and multiple spot cards for verification when required.

Pricing plans

Collaborators

SmartSpot Quality developed in collaboration with:

The Department of Molecular Medicine and Haematology – Wits University

Centre for Disease Control, Centre of Excellence for Biomedical TB Research, AIDS Clinical Trial Group, South African National Health Laboratory Services National Priority Program

Awards

  1. Winner of Innovation Prize for Africa 2015 – Social Impact Award
  2. Winners of the Gauteng Accelerator Program Biosciences Award – 2014
  3. Winner of the NHLS National Innovation Award (2013).
GAP
IPA