Monkeypox: Current and Upcoming Diagnostic Tests & Biosafety Guidelines

The World Health Organization (WHO) classified monkeypox as a zoonosis, that is, a disease that is transmitted from animals to humans. Since early May 2022, many instances of monkeypox have been reported in countries where the disease is not endemic and continues to be reported from several endemic countries. 
 
The monkeypox virus is classified as an orthopoxvirus and causes a disease with symptoms similar to smallpox. Transmission between humans is limited. Monkeypox can be transmitted through contact with body fluids, internal mucosal surfaces, skin lesions in the mouth or throat, respiratory droplets, and contaminated objects. Sometimes, it is difficult for clinicians unfamiliar with diseases resembling monkeypox to differentiate it from other viral, bacterial, or other conditions. Nonspecific clinical presentations, lesions, and inflammation of the pharyngeal mucosa have been observed. These symptoms can be seen in many other viral and non-viral infections. For these reasons, accurate laboratory diagnosis of the disease is of particular importance.
 
Under current guidelines, anyone suspected of having monkeypox should be tested in properly equipped laboratories by personnel trained in the relevant safety procedures. The confirmation of monkeypox virus infection is based on the Nucleic Acid Amplification Test (NAAT), using conventional or real-time Polymerase Chain Reaction (qPCR), for the detection of viral DNA. Antigen and antibody detection methods do not distinguish between orthopoxviruses and are therefore not recommended.
 
A Laboratory Information Management System (LIMS) can help streamline and automate operations in a clinical diagnostic laboratory. A clinical diagnostic LIMS enables laboratories to manage patient data, manage the collection and storage of monkeypox samples, report test results following FDA and CDC reporting guidelines, deliver test results securely and digitally, and manage workflows, SOPs, staff training, and inventory.
 
Learning Objectives:

1. Review the monkeypox virus and its characteristics from the current outbreak.

2. Discuss the latest guidelines and recommendations for testing.

3. Identify how a LIMS can help streamline and automate operations in clinical diagnostic laboratories.