ErbaMDx MonkeyPox RT-PCR kit launched by Transasia-Erba provides higher accuracy

Erba Transasia announces the commercial launch of reportedly, the country’s first indigenously manufactured MonkeyPox PCR test kit. Validated by the Indian Council for Medical Research (ICMR), this kit received emergency approval from the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. The newly launched ErbaMDx MonkeyPox RT-PCR Kit can provide a highly accurate confirmatory test for MonkeyPox, as compared to rapid tests.

In response to the recent public health emergency and a surge of mpox cases, the Indian Health Ministry has emphasised the need for effective surveillance and has geared up a network of 32 testing laboratories across the country for early diagnosis. The MonkeyPox RT-PCR Kit introduced by Erba Transasia 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 MonkeyPox RT-PCR kit delivers 97.5 per cent sensitivity and 100 per cent specificity, with results available in less than an hour. It leverages existing COVID-19 lab infrastructure and has a 12-month shelf life. The kit ensures zero cross-reactivity with other orthopox viruses or organisms, thereby enhancing its diagnostic precision. 

Reportedly, the ErbaMDx kit is cost-effective and has a user-friendly design, enabling its widespread use both in India and globally. The kit’s lyophilized components allow for shipping and storage at ambient temperatures and are advantageous for deployment in regions with limited cold chain infrastructure. Further, the kit 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 of Transasia Diagnostic at the IVD facility in Andhra Pradesh MedTech Zone (AMTZ) support the manufacturing of over 50 million mpox tests per month, ensuring a robust supply to meet the growing global demand. The first batch of mpox kits from Erba Transasia will be made available very soon.