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• TB is a major global killer; in 2011, an estimated 1.4 million people died from the
disease .
• The traditional diagnostic gold standard, sputum culture, can take 6–8 weeks.
• This requires a biosafety infrastructure , that limits its use to reference laboratories.
• The Xpert MTB/RIF test (Cepheid), which became available in 2009, is revolutionizing
TB identification, bringing diagnosis closer to the point of care.
• The cartridge-based, fully automated nucleic acid amplification test (NAAT) can be
used by a relatively unskilled health worker to simultaneously detect both the presence
of the Mycobacterium tuberculosis pathogen and whether the strain harbours common
rifampicin resistance related mutations in less than 2 hours.
• The test was found to be highly sensitive and specific by a large multi-country study in
2008/2009: the test correctly identified 98.2% of smear-positive TB, 72.5% of smear-
negative cases
• Same-day treatment initiation in over 80% of new cases
• One study estimates that the technology could prevent over 4 million deaths between
2015 and 2050.
• With the support of the WHO, over 1 million tests have been purchased by low- and
middle-income countries since December 2010
Source : http://medind.nic.in/laa/t15/i2/laat15i2p127.htm
India Time ..
• US-based molecular diagnostics company Cepheid Inc in July 2018 announced its plans
to establish a manufacturing unit in the country to improve Tuberculosis (TB)
diagnostics.
• The new manufacturing unit would produce MTB/RIF test cartridges, contribute to the
government's "Make in India" initiative and thus bringing the company's global expertise
in TB diagnostics to India, the company said in a statement.
• Funding from the Bill & Melinda Gates Foundation, exemplifies this issue, as the
public–private partnership (PPP) agreement dictated that the device be made available
to government facilities at cost, although the firm is free to sell to private facilities at
market prices