RT-PCR TESTING KITS (Syllabus: GS Paper 2 – Health)

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Context: The Central Drugs Standard Control Organisation has granted approval to Siemens Healthineers for the manufacture of RT-PCR testing kits for detection of Mpox.


RT-PCR Testing Kits

  • About: It is a molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus.
  • Introduced under: Brand name ‘ErbaMDx Monkeypox RT-PCR Kit.
  • Developed by: Andhra Pradesh MedTech Zone (AMTZ), a research body of the state government, in collaboration with Transasia Diagnostics.
  • Utilization: This assay can leverage existing COVID-19 testing infrastructure, enhancing efficiency and minimizing the need for new equipment.
  • Features:

o Shelf Life: With a 12-month shelf life and zero cross-reactivity with other orthopoxviruses, the kit promises exceptional accuracy and dependability.

o Its use of lyophilised components, which allows it to be shipped and stored at ambient temperatures.

o Focus: These assay kits demonstrate Siemens Healthineers' commitment to improving 'Access to Care,' making advanced diagnostics more widely available.

  • Boost to "Make in India" Initiative: The approval marks a significant achievement for the "Make in India" initiative, highlighting the company's commitment to local manufacturing.
  • Contribution to Public Health: This assay represents a critical advancement in combating the Monkeypox public health emergency by enabling early and accurate detection.


MPOX Virus

  • About: Mpox, formerly known as monkeypox, is a viral disease caused by the Monkeypox virus.
  • Belongs to: Same family as the virus that causes smallpox.
  • Virus Type: There are two main types of Monkeypox virus: Clade I and Clade II.


Central Drugs Standard Control Organization (CDSCO)

  • About: CDSCO establishes standards and measures to ensure the safety, effectiveness, and quality of drugs, cosmetics, diagnostics, and medical devices within the country.
  • Headquarters: New Delhi.
  • Ministry: Ministry of Health & Family Welfare.


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