New In Vitro Diagnostic Challenges and Opportunities in Monkeypox Outbreak

Monkeypox is ascribable to the monkeypox virus (MPXV) belonging to the Orthopoxvirus genus in the family Poxviridae. Though a close relative of the smallpox virus, vaccinia virus, and cowpox virus, MPXV is weaker in severity and transmission. Due to its zoonotic nature, monkeypox is believed to transmit from an animal source to humans following intraspecies transmission. Though the actual natural host of the monkeypox virus has not been established yet, African rodents and non-human primates are suggested to be possible reservoirs or vectors, given that monkeypox seems to be endemic in Central and Western African countries and people in these regions have close contact with these animals.

This disease is causing a much-covered monkeypox scare ever since the WHO's report of over 2,000 infections in 42 non-endemic countries. It's pointed out that monkeypox virus surveillance is limited in non-endemic countries and there are few medical-use monkeypox tests currently, but surveillance measures will see growth with the increase in case numbers and control efforts.

With regard to laboratory testing for detection of the monkeypox virus, the WHO has released guidelines saying that based on nucleic acid amplification testing (NAAT), monkeypox virus infection can be confirmed using real-time or conventional polymerase chain reaction (PCR) to detect unique viral DNA sequences. It also indicates that PCR can either be used alone or in combination with DNA sequencing. In the interim guidance of testing for the monkeypox virus in laboratories, it's recommended that skin lesion material, including swabs of the lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts, would be the ideal specimen type for confirmation of monkeypox.

With the unveiling of the first draft genome from a swab of a confirmed case, researchers can develop PCR assays to detect MPXV from scabs or blisters of potentially infected people. Up to now, such PCR testings have been available at the U.S. Centers for Disease Control and Prevention (CDC) and some major laboratories. And some industry giants have taken the lead in monkeypox PCR tests. Moreover, a number of IVD vendors and companies have acted promptly in monkeypox virus IVD kit development, including test kits that generally detect all orthopoxviruses, that detect monkeypox viruses only, and that can identify the orthopoxviruses while clarifying the existence of monkeypox virus.

Experts introduce that the monkeypox outbreak finds similarities to the Zika outbreaks seen in 2015 and 2016—not caused by new viruses while reaching non-endemic countries with small pockets of cases worldwide. A strategy of ring vaccination, which means vaccinating people who encountered a positive case and isolating them, had ultimately contained the Zika outbreaks. Meanwhile, 50 in vitro diagnostic products were launched to detect the Zika virus.

Therefore, this pattern is expected to control the monkeypox outbreaks as well. Measures include efficient contact tracing methods, the proven ring vaccination strategy, and increasing diagnostic tests. In addition, monkeypox is believed to be appropriately and timely surveilled and controlled, in that the public has increased awareness of viral pandemics due to the severity of the COVID-19 pandemic and monkeypox is arriving at a time of high precaution, adequate supplies of personal protective equipment, and ready-for-use monkeypox vaccines.

Although the experience of the COVID-19 epidemic has made laboratories and IVD companies ready for this monkeypox scare, healthcare organizations and laboratories will be confronted with challenges in testing capacities and supply chains. On the other hand, the Monkeypox may not be another COVID-19-like pandemic, but new pathogens may periodically appear and create a need for new IVD and research tools, which substantially is a chance of gains and growth opportunities for the monkeypox IVD market.

Enthusiastic science communicators and freelancer with a simple mission - to make science exciting and present it in an innovative, interesting, and engaging style, and discover science full of curiosity and eager to learn more.