Experts hail indigenous test kit for monkeypox

A patient with an mpox infection in Africa documented by Dr Subhash Hira

Health experts including virologists have welcomed the indigenously developed kit for Reverse-transcription Polymerase Chain Reaction (RT-PCR) tests for diagnosing monkeypox. These test kits have been validated by Indian Council of Medical Research (ICMR), Institute of Virology in Pune and approved by the Central Drugs Standard Control Organisation (CDSCO).

Mid-day in its report 'India concerned about WHO mpox global alert' dated August 20, 2024 had highlighted the need for National Centre for Disease Control (NCDC) and ICMR to monitor the Indian airports for flyers with mpox symptoms.

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WHO emergency of International concern

Cases of monkeypox, having originated in the Democratic Republic of Congo, have been reported from different parts of the world since May 2022. As per Centre for Disease Control (CDC), Africa, so far Mpox has claimed over 500 deaths in the last three months in the Democractic Republic of Congo.

These tests will help ministries of health to initiate their surveillance activities. Representation Pic

Made in India

Dr Subhash Hira

"It is heartening to learn that three Indian health diagnostic companies have successfully developed rapid RT-PCR tests for mpox at lightning speed. These tests have been validated by ICMR's Institute of Virology in Pune, and approved by CDSCO. It will be up to the diagnostic companies to launch their kits in the global markets because these tests will help ministries of health to initiate their surveillance activities. The ports of entry of travellers and also suspicious pox-like skin conditions presenting at clinics and hospitals will provide useful information of mpox spread in India," said Dr Subhash Hira, professor of Global Health at University of Washington USA and a member of recently constituted WHO panel for mpox.

Mpox not big threat as COVID-19 pandemic

The key actions of the response to the outbreak include informing those frequent travelers who are most at risk for mpox with accurate information; offering pre and post-exposure mpox vaccination to individuals at risk; stopping further spread with use of hand sanitisation; and protecting vulnerable individuals and frontline workers."Mpox is nowhere as big a threat as compared with COVID-19 pandemic," said Dr Hira.

Kit seems to be excellent

Dr T Jacob John

Dr T Jacob John, well known Virologist from Vellore, Tamil Nadu said, "The India designed kit of PCR diagnostic reagent seems to be excellent. A new strain of monkeypox which is more virulent is called Clade 2, the original being Clade 1. Eternal vigilance is the price of freedom from infectious diseases. Yes, we have to be vigilant," said Dr John.

Skin contact mode of transmission

When asked if children/adults are at risk of getting mpox, "As for risk to children and adults, careful observations and regular reports are essential. We cannot predict, but we must observe. It seems that skin contact is the mode of transmission. Smallpox virus was respiratory-transmitted. Thus large outbreaks of mpox cannot occur. But clusters of cases will occur. I hope the Director General of Health Services will tell us more in real-time," said Dr John.

Test results in 40 minutes

Dr Wiqar Shaikh

Dr Wiqar Shaikh, professor of medicine, Grant Medical College and Sir JJ Group of Hospitals that the RT-PCR test kits used to diagnose mpox is being imported till now. He said an RT-PCR kit for mpox indigenously developed in India delivers results in just 40 minutes and is significantly faster than traditional methods that take 1 to 2 hours. Dr Shaikh said that the CDSCO has granted approval for the manufacture of these indigenous kits. He added that the kit has also been validated by the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune.

Dr Shaikh said that these kits have a 100 per cent sensitivity and specificity and comply with the highest global standards. Dr Shaikh said that the indigenously developed kits for mpox will be manufactured by a manufacturing unit in Vadodara, which has a production capacity of one million tests per annum.

Boon to patients

Dr Ketan Vagholkar

"Monkey pox is a complex disease. It did not have any specific easily accessible laboratory test for accurate diagnosis. It relied mostly on clinical features. The development of an RT-PCR test kit with excellent sensitivity and specificity will serve as a boon to patients. As the test kit is indigenously developed, it will be easily available and more affordable. This will enable health authorities to curb the spread of the disease by early diagnosis. Another advantage of the new test kit is that it provides quick results without fancy equipment," said Dr Ketan Vagholkar, professor of Surgery at DY Patil Medical College, Navi Mumbai.

First mpox case in India since March

On Sunday, the Union Health Ministry announced the country's first suspected case of mpox since March but withheld details about the location where the case was detected.

If positive, this would be the 31st case in the country since 2022. "The patient has been isolated at a designated hospital and is currently stable. Samples are being tested to confirm the presence of mpox. The case is being managed according to established protocols, and contact tracing is underway to identify potential sources and assess any impact across the country," the ministry said in a statement.

Dr. Ishwar Gilada, president emeritus of the AIDS Society of India and a key figure in the early treatment efforts for HIV patients in the 1980s in the city, told mid-day that it has been a longstanding demand to withhold the location of stigmatised infectious diseases in the initial stages to prevent discrimination.

"There is a lot of public curiosity in the initial days and once the location is disclosed, there are more chances that details of the patient will be out as well. That is what happened with HIV patients in the 80s. It adds to stigma," he said.

Mpox is caused by the monkeypox virus, which belongs to the same family of viruses as the one responsible for smallpox. Symptoms typically include rashes on the hands, feet, chest, face, mouth, or near the genitals, which initially appear as pimples or blisters and can become painful. Other common symptoms include fever, swollen lymph nodes, and muscle aches. Most people recover within two to four weeks without needing specific treatment.

The virus primarily spreads through close physical contact, including skin-to-skin contact, with infectious lesions or bodily fluids. It can also be transmitted through respiratory droplets during prolonged face-to-face contact. While anyone can contract mpox, men who have sex with men and individuals with multiple sexual partners have been identified as populations at higher risk of transmission due to the nature of close physical contact.

It is worth noting that mpox has not been designated as an STD as of now. "The problem is that people are treating it at par with COVID-19, which is not the case. Mpox is not COVID, it does not spread like COVID. Neither is it like HIV, people recover. What is needed right now is involvement of the National AIDS Control Society (NACO) who have a good relationship with the LGBTQ community and will be able to better screen and provide counselling instead of conducting airport screenings," Dr Gilada said.

He further noted that those who were vaccinated against smallpox will not be at risk of contracting the virus. "So, the population at risk are sexually active individuals between about 18 to 40/45," Dr Gilada said.

With inputs from Eshan Kalyanikar