Visakhapatnam: In a significant development in the Indian healthcare industry, Andhra Pradesh MedTech Zone (AMTZ) Vishakhapatnam has registered another achievement by successfully coming up with India's first indigenously developed monkeypox RT-PCR Kit.
This AMTZ, which provided many products needed by the health sector during the Covid-19 pandemic, has come up with another one that can be a game-changer considering how monkeypox or mpox has been declared as a public health emergency of international concern by the World Health Organization recently.
The Med Tech Zone in partnership with Transasia Diagnostics Pvt Ltd developed ErbaMDx MonkeyPox RT-PCR Kit. Validated by the Indian Council for Medical Research (ICMR), this kit received emergency approval from Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India on Saturday.
Med Tech Zone CEO Dr Jitendra Sharma said that this discovery reflects India's position at the forefront of global health innovations. The kit represents a significant advancement, providing a highly accurate confirmatory test for MonkeyPox, as compared to rapid tests.
Pertinently, the recent global surge in Mpox cases has prompted several countries, particularly in Europe, to raise their alert levels. The European Centre for Disease Prevention and Control (ECDC) has upgraded its risk assessment to “moderate” due to a new strain detected in Sweden. In response to the global situation, the Health Ministry in India has also emphasized the need for effective surveillance and has geared up a network of 32 testing laboratories across the country for early diagnosis.
Features of the kit
In response to this health emergency, the MonkeyPox RT-PCR Kit is an innovative product characterized by its high sensitivity and ease of use. The kit features a uniquely formulated primer and probe, ensuring enhanced accuracy in detection. This advanced technology has been validated through rigorous testing, which confirms its robustness and reliability.
The ErbaMDx kit is notable for its cost-effectiveness and user-friendly design, enabling its widespread use both in India and globally. The kit’s lyophilized components, which allow for shipping and storage at ambient temperatures, are particularly advantageous for deployment in regions with limited cold chain infrastructure. This feature expands access to reliable diagnostics in underserved areas, helping to bridge the healthcare gap in critical situations.
The ErbaMDx MonkeyPox RT-PCR kit delivers 97.5% sensitivity and 100% specificity, with results available in less than an hour. It leverages existing COVID-19 lab infrastructure and has a 12-month shelf life.
Further, the kit is designed to ensure zero cross-reactivity with other orthopox viruses or organisms, thereby enhancing its diagnostic precision. It is designed for use with commercially available open-platform real-time PCR systems equipped with a minimum of three optical channels. Consequently, it is suitable for application in any PCR testing laboratory developed for molecular diagnostics testing during the COVID-19 pandemic.
The production capabilities TDPL at the state-of-the-art IVD facility in AMTZ support the manufacturing of over 50 million MPox tests per month, ensuring a robust supply to meet the growing global demand.
Suresh Vazirani, Founder Chairman, Erba Transasia Group, said, “As a leading manufacturer of clinical diagnostic solutions, we are committed to utilizing our well-established manufacturing and rapid response capabilities to strengthen epidemic preparedness and increase access to life-saving diagnostics for those who need them most at an affordable price. Our manufacturing facility in AMTZ, which is Asia’s largest, enables us to respond more rapidly and equitably to public health disease outbreaks, particularly in countries where access to diagnostic services are limited.”
This launch marks a significant milestone in India’s healthcare sector, demonstrating the country’s capacity to lead in global health solutions through local innovation and expertise. The first batch of MPox kit will be made available very soon.
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