Who Approves First Diagnostic Test For Mpox

WHO APPROVES FIRST DIAGNOSTIC TEST FOR MPOX

The World Health Organization (WHO) has announced the Emergency Use Listing (EUL) for the first diagnostic test for mpox (formerly known as monkeypox).

This is an important step in improving testing around the world as outbreaks continue.

WHAT IS MPOX?

Mpox, formerly known as monkeypox, is a viral disease caused by the monkeypox virus. It is part of the same family of viruses as smallpox and is typically found in certain regions of Central and West Africa.

1. The disease can spread from animals to humans and can also be transmitted between humans.
2. Symptoms include fever, rash, and swollen lymph nodes, and it often leads to lesions on the skin.
3. While it can be serious, most cases are mild, and there is a vaccine available that can help prevent infection.

Outbreaks outside of endemic regions have raised public health awareness, prompting efforts to control its spread.

KEY HIGHLIGHTS

• Diagnostic Test Approved: The Alinity m MPXV assay, created by Abbott Molecular Inc., has received emergency approval. This test can quickly check for the monkeypox virus in samples taken from skin lesions.
• Importance of Early Diagnosis: Fast and accurate testing is crucial for timely treatment and control of the virus, especially in areas heavily impacted by mpox outbreaks.

CONTEXT OF APPROVAL

• Outbreak Statistics: In 2024, more than 30,000 suspected mpox cases have been reported in Africa, particularly in the Democratic Republic of the Congo, Burundi, and Nigeria.
• Only 37% of suspected cases in the Democratic Republic of the Congo have been tested this year, showing a significant lack of testing.
• Testing Gaps: Limited testing options and delays in confirming cases are contributing to the ongoing spread of mpox, especially in underserved areas.

TECHNICAL DETAILS OF THE ALINITY m MPXV ASSAY

• Method: The test uses a method called nucleic acid amplification testing (NAAT), specifically real-time or regular polymerase chain reaction (PCR), to check for the monkeypox virus.
• Sample Requirement: The test needs lesion material from suspected cases to confirm infections by detecting the virus’s DNA from rash samples.
• User Skills: It is meant to be used by trained laboratory staff who are experienced in PCR techniques.

WHO’s STRATEGY

• Enhancing Access: Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines, stressed that this approval is an important step toward increasing testing availability in affected countries, which is essential for controlling the virus.
• Quality Assurance: Ensuring access to reliable medical products is key to WHO’s mission in fighting mpox, especially in areas with limited healthcare.

EMERGENCY USE LISTING (EUL) PROCESS

• Purpose: The EUL process allows for the quick availability of essential medical products—like vaccines, tests, and treatments—during major public health emergencies.
• Call for Submissions: On August 28, 2024, WHO asked manufacturers of mpox tests to express interest in the EUL process, acknowledging the urgent need for better testing worldwide.
• Ongoing Evaluations: WHO is currently reviewing three more submissions for EUL and is in talks with other manufacturers to expand the available options for quality diagnostic tests.

Duration of Emergency Use

• The EUL for the Alinity m MPXV assay will remain valid as long as the public health emergency related to mpox continues, ensuring ongoing access to this important diagnostic tool.

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