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

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.