Monkeypox Testing Expands as Cases Increase Rapidly

Monkeypox RT-PCR Detection Kit

As the COVID-19 pandemic enters its third year, new infectious disease threats continue to arise. In the last few months, monkeypox outbreaks have been identified in Europe, United States and Australia. This again presents new challenges to global public health authorities. The CDC is tracking the monkeypox outbreaks in the United States and internationally. As of September 20th, 2022, there have been 62,406 confirmed cases of the monkeypox virus spreading worldwide. As the cases trend upwards, medical technology companies are working to develop molecular diagnostic tests for the detection of the monkeypox virus, such as the newly released Monkeypox RT-PCR Detection Kit.

Monkeypox is a rare viral disease caused by DNA belonging to the Orthopoxvirus genus in the Poxviridae family. Monkeypox virus is an enveloped double‐stranded DNA virus. It is transmitted human to human through close physical contact with lesions (vesicles), mucous membranes, body fluids and during prolonged face-to-face contact. The virus enters the body through broken skin, the respiratory tract or the mucous membranes. Symptoms start within 3 weeks of exposure, and the illness typically lasts 2-4 weeks.

In September 2019, the U.S. FDA approved the Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is currently the only FDA-approved vaccine for the prevention of monkeypox disease. While initially for subcutaneous (SC) use, the FDA recently authorized, for emergency use, the intradermal administration of this vaccine – in a lower dose- for individuals 18 years or older. The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk for monkeypox infection; in these individuals Jynneos is administered by subcutaneous injection. The ACAM2000 Smallpox vaccine has had it use expanded for monkeypox under FDA’s Expanded Access Investigational New Drug (IND) mechanism, which requires informed consent along with additional IND requirements. It does not have FDA approval or emergency use authorization for monkeypox.

The United States government has accelerated the monkeypox vaccine effort, and has ordered an additional 1.8 million doses of the vaccine.

Aside from vaccine distribution, monkeypox testing is also an important part of the effort to prevent the virus from spreading rapidly. The confirmation of monkeypox infection depends upon the type and quality of the specimen as well as the laboratory test. The polymerase chain reaction (PCR) is the preferred method of accurate detection for infectious diseases.

The main objectives of case investigation and surveillance for monkeypox virus in the current scenario are to detect the confirmed cases and the sources of infection, in order to provide optimal clinical care, prevent further transmission, identify and manage contacts and tailor effective control and prevention methods based on most commonly identified routes of transmission.

The Viasure Monkeypox RT-PCR Detection Kit, intended for Research Use Only (RUO), can provide qualitative identification of DNA from monkeypox virus in serum, vesicle/cutaneous-skin fluid and fluid from wounds. Reagents are available in lyophilized form, which permits the product to be shipped and stored at room temperature without the need for special transport or storage. Monkeypox RT-PCR Detection Kit Tests are stable for 24 months from date of manufacture when stored at room temperature. Primers, probes and lyophilized mastermix for this test are supplied in PCR strip or tube formats.

This RUO Monkeypox kit offers a very simple and user-friendly workflow. Rehydration buffer is added to the lyophilized reagent wells, followed by the addition of extracted nucleic acid samples. The test can then be run. Jant Pharmacal’s technical staff can assist with the implementation of Monkeypox testing, including selection of appropriate extraction instrumentation and RT-PCR analyzers. Detailed information about the Monkeypox RT-PCR Kit is available here.