The current monkeypox outbreak is associated with the West African clade of the monkeypox virus. The diagnostic process begins with the patient being evaluated for monkeypox by a healthcare provider. Then the patient will complete diagnostic testing based on clinical and epidemiological factors linked to the likelihood of infection. If the patient is positive, it is a probable monkeypox case, therefore isolation and treatment begin as well as contact tracing and consideration for vaccination are completed.
As with any procedure laboratories should perform site specific and activity specific risk assessments to determine risks and minimize them as much as possible. For laboratories completing monkeypox virus testing, specific biosafety precautions should be implemented for the specimen being tested. Laboratory personnel must be trained on the use of personal protective equipment (PPE), specimen collection, storage, packaging and transport. Specimens should always be considered potentially infectious and handled with caution. For non-lesion specimens like urine, blood, etc. the amount of the virus is likely to be low and vaccination is not recommended for those that are handling or processing the clinical specimens. Yet, standard precautions to protect against infectious agents within the specimen are still recommended. Safety protocols and the protection of lab workers should be of the utmost importance and the amount of staff testing specimens should be limited. Lesion specimens are the recommended type for laboratory confirmation, both dry swabs and viral transport media (VTM) can be used. Lesion specimens have the highest amount of the virus, so vaccinated (smallpox vaccination within the past 3 years) individuals should perform any work handling these types of specimens. If only non-immunized individuals are available additional PPE should be used to prevent risk for exposure. Testing specimens in Biosafety Level 2 (BSL-2) containment with Biosafety Level 3 (BSL-3) practices is recommended for non-immunized personnel. Necessary equipment, engineering controls, PPE and assays should be used.
Collection of additional specimen types for research purposes can be considered if allowed by the appropriate ethical review board and can be handled safely. These would not be intended for diagnostic purposes and do not need to be collected outside of research settings.
Once viral DNA is extracted with a validated extraction protocol it is non-infectious and can be handled using BSL-2 containment facilities and procedures. Viral inactivation of the specimen is recommended before placing these on any automated platform. It is recommended to use a Class II Biological Safety Cabinet (BSC) to provide a barrier between the specimen and individual when handling monkeypox specimens. When a BSC cannot be used a combination of PPE and containment devices to create a barrier between the specimen and personnel should be used.
For any procedure that generates aerosols and cannot be contained, respiratory protection should be implemented with respirators, powered air purifying respirators or other high level of respiratory protection. Cleaning and disinfection procedures should be performed using hospital-grade disinfectant, such as quaternary ammonium compounds and 0.5% bleach.
All monkeypox virus waste should be decontaminated before on-site disposal by using an approved method, such as autoclaving. Any waste to be decontaminated outside of the lab should be placed in a closed, durable, leak-proof container for transport. All waste must comply with local, regional, state, national and international regulations.
All labs should follow national reporting requirements and all test results should be immediately reported.