Recent reports indicate that the Ebola outbreak may last until the end of 2015 as the vaccines need more time to be tested. While specialized centers have been built to provide people with proper medical treatment, continual efforts are needed to fight Ebola which, according to the World Health Organization (WHO), has claimed about 7,300 lives so far.
The main area of infection has been West Africa though several cases have been also reported in Europe and the US. One important matter that has been widely discussed is how clinical laboratories can safely manage routine testing of specimens from a PUI (patient under investigation) for EVD (Ebola virus disease).
What the CDC Recommends
The Centers for Disease Prevention and Control (CDC) recommends that clinical laboratories in the U.S. can safely manage diagnostic specimens from PUI for EVD by adhering to the CDC’s guidelines and the OSHA bloodborne pathogens standard for other known infectious diseases transmitted through blood or body fluids, such as HIV and hepatitis viruses.
In an ACC webinar held on October 7 about laboratory practices for managing suspected Ebola specimens, experts pointed out that many clinical laboratories are planning to treat patients suspected of having Ebola using only point-of-care (POC) instruments. This strategy is aimed at minimizing the transport of infectious samples and also avoiding the handling the decontamination of complex and expensive central laboratory analyzers.
Though the CDC does not recommend limiting tests to POC, it states that clinical laboratories adding POC instruments specifically for testing PUI for EVD should provide training and ensure that staff practices these procedures in advance while wearing the appropriate PPE (personal protective equipment). Switching to new devices or PPE without sufficient training and practice could lead to breaches in safe practices, which can increase the chances of contaminating the clothes, mouth, or eyes of laboratory personnel handling the equipment.
The CDC recommends that the laboratory’s director, biosafety officer, and other responsible personnel should perform risk assessments to determine the potential for sprays, splashes, or aerosols generated from laboratory procedures.
The CDC, in consultation with healthcare personnel, remains ready to answer questions on specimen handling and testing specific to the patient’s needs and facility capabilities in the event of a patient being confirmed with EVD.
Handling Laboratory-specific Issues
An article published by the AACC cites an expert as saying that the CDC’s recommendations for labs receiving samples from patients suspected of Ebola infection is limited to following standard precautions, and as an added measure, using a certified class II biosafety cabinet or splash guard with PPE that protects skin and mucous membranes. Hospitals have had to deal with important laboratory-specific problems such as which instruments to use, or how to decontaminate them. Some of the main challenges facing laboratories handling specimens from patients under investigation for Ebola are
- Manufacturers cannot assure that dispersal of infectious disease agents, including Ebola virus, is completely prevented during specimen testing or if an instrument malfunctions or is misused
- A tube rupture in a centrifuge or exposure due to another kind of aerosolization could lead to infection
- The extent of decontamination that a lab can realistically perform
- Handling waste disposal
- Preparation of a realistic and straightforward plan that can be implemented by trained staff
Experts recommend that labs should not go by only the government’s infection control library, and should hold discussions with specialists such as industrial hygienists as well as instrument manufacturers about their specific circumstances. Once they come up with a plan, clinical laboratories will have to practice it to ensure proper handling of specimens from a PUI (patient under investigation) for EVD (Ebola virus disease) when they show up.