The Oswaldo Cruz Foundation (Fiocruz), through the Institute of Technology on Immunobiologicals (Bio-Manguinhos/Fiocruz), filed, on August 10th, the request for registration of two molecular in vitro diagnostics (IVDs): the monkeypox molecular kit (MPXV) and the 5PLEX OPV/MPXV/VZV/MOCV/RP molecular kit.

The monkeypox molecular kit (MPXV)

The monkeypox molecular kit (MPXV) is based on real-time PCR technology with multiplex assays. Developed from the recommendations of the World Health Organization (WHO) for the diagnosis of the disease, the kit can identify the genetic material (DNA) of the causative virus by collecting material taken from the skin rashes (pustules) present in the individual with suspected of infection by the virus, of the genus Orthopoxvirus, belonging to the family Poxviridae.

The IVD identifies, in the same human sample, two genetically distinct strains of the monkeypox virus: the Central African strain (Congo) and the West African strain, the latter with confirmed circulation in Brazil.

Its use is based on Protocol 1: Monkeypox detection and typing: assay containing general monkeypox targets / West Africa / Central Africa (Congo).

The 5PLEX OPV/ MPXV/ VZV/ MOCV/ RP Molecular Kit

The 5PLEX OPV/ MPXV/ VZV/ MOCV/ RP molecular kit, based on the same technology, is intended for Protocol 2, which allows clinical differentiation in cases previously classified as “negative” (without infection by the virus that causes monkeypox), providing greater capacity for diagnostic clarification, with the differentiation of related viruses, important for epidemiological surveillance in the Brazilian Public Health System.

It performs the detection and differential diagnosis: assay containing the general Orthopox / General Monkeypox / Varicella Zoster (VZV) / Molluscum contagiosum (Molluscum contagiosum) targets, in addition to the kit control (RNaseP, also present in the MPXV kit).

Rapid implementation solutions throughout the national territory

Faced with the identification of the first cases in Brazil and a possible increase in the spread of the disease in the national territory, the Institute developed the new molecular IVD and has already produced 12 thousand reactions from each of the two protocols established for use in research.

Both molecular diagnostics identify the genetic material of the monkeypox virus, and the technology used in them allows their immediate use in platforms that already identify other targets in the network of central public health laboratories (Lacens), in case the Ministry of Health needs to implement its use.

"The importance of health emergency preparedness actions is expressed in this rapid offer of molecular IVDs in response to monkeypox. A more effective supply chain, after the experience with Covid-19, and a strengthened local productive arrangement contribute to national autonomy concerning essential inputs to face public health problems, which have arisen with more frequency and greater reach", highlighted the president of Fiocruz, Nísia Trindade Lima.

“The offer of molecular kits in technology that allows their immediate use in states, in addition to the Federal District, is proof of Bio-Manguinhos' commitment and prompt response to the challenges that continue to arise for public health. The emergence of the disease in a period in which we are still immersed in the Covid-19 pandemic proves the importance of public laboratories for the country”, said the director of the Institute, Mauricio Zuma.

Bio-Manguinhos can scale up the production of these new molecular IVDs without impacting the supply of other products in its portfolio, if the disease spreads among the population and the demand for differential and evidential diagnosis grows.

Journalist: Paulo Schueler.
Image: Bernardo Portella.
Translation: Juliana Xavier.