The T-SPOT.TB test will be officially launched in India during the 46th Edition of MICROCON in Lucknow
Revvity, a global company that leverages innovation in Diagnostics and Life Sciences has announced the country launch of its T-SPOT.TB test for latent TB screening, at MICROCON in Lucknow.
Revvity’s T-SPOT.TB is the only FDA-approved, commercially available IGRA (interferon gamma release assay) based on the ELISPOT technology. This technology includes the isolation, washing and counting of peripheral blood mononuclear cells (PBMCs) from whole blood to standardise the test and provide reproducible results for reliable detection even in challenging-to-screen groups, such as the immunosuppressed[i].
Based on the ELISPOT technology, the T-SPOT.TB test is the only WHO recommended IGRA that uses a standardised sample, reducing the influence of factors in the blood which may affect performance and normalising for cell number variation. The WHO diagnostic guidelines acknowledge the benefits of the normalisation step prior to cell stimulation required in the T-SPOT.TB test.[ii] Normalising the T-cell count before cell stimulation can help obtain accurate results in populations with weakened immune systems.[iii] In addition, the T-SPOT.TB test does not cross-react with the BCG vaccine[iv], which is commonly used in India.
Shripad Joshi, President, India & South Asia, Revvity said, “With approximately 40 per cent of the Indian population being infected with latent TB, detecting the infection before it progresses to active disease, which is symptomatic and infectious, is paramount. We recognise the critical role that collaboration between the public and private sectors plays in the government’s mission of eradicating TB by 2025. As a result, we are committed to working closely with the Indian healthcare sector to integrate our reliable, single visit T-SPOT. TB test into the country’s existing healthcare infrastructure, increasing accessibility and affordability of latent TB screening.
“We have 20 years’ experience in TB screening and have been collaborating with several healthcare systems around the world. We are now thrilled to be able to start equipping healthcare professionals in India with advanced screening tools that can support the Government’s mission effectively, decreasing costs associated with treating active or drug-resistant TB, and more importantly, saving lives.”
The T-SPOT.TB test is one of the three IGRAs that are recommended by WHO as alternatives to the tuberculin skin test (TST) or the Mantoux test for the detection of TB infection. The T-SPOT.TB test is available in over 50 countries including in Europe, China, Japan, and the US, and is in the list of in-vitro diagnostics (IVDs) recommended by WHO for use in countries to improve access to IVD testing and advance universal health coverage.[v]
Automation of the T-SPOT.TB test is possible using the T-Cell Select TM reagent kit, and automated platforms are available for low, medium, and high throughput settings. The use of the T-Cell SelectTM reagent kit in the automated workflow allows for the blood samples to be transported and stored at ambient temperature for up to 54 hours prior to processing, improving sample collection logistics.
Revvity is launching its ELISPOT-based IGRA T-SPOT.TB at the 46th Edition of MICROCON held at King George’s Medical University in Lucknow, Uttar Pradesh.
Reference
[i] https://www.imrpress.com/journal/FBL/27/10/10.31083/j.fbl2710282/htm
[ii] WHO Guidelines Approved by the Guidelines Review Committee. In: WHO consolidated guidelines on tuberculosis: Module 3: diagnosis – rapid diagnostics for tuberculosis detection. Geneva: World Health Organization; 2021.
[iii] Wong SH, Gao Q, Tsoi KK, et al. Effect of immunosuppressive therapy on interferon γ release assay for latent tuberculosis screening in patients with autoimmune diseases: a systematic review and meta-analysis. Thorax. 2016;71(1):64-72.
[iv] Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-IVD-UK-v4. Abingdon, UK. 2022
[v] The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). Geneva: World Health Organization; 2021 (WHO Technical Report Series, No. 1031). Licence: CC BY-NC-SA 3.0 IGO. Available from: https://www.who.int/publications/i/item/9789240019102
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