Forbes | November 1, 2014
By Bill Frist
Imagine waking up with a fever and nausea in West Africa. You would probably be equal parts curious about the cause of your symptoms, and terrified that it might be fatal. Ebola is actually the least likely cause of your fever, unless of course you had been exposed to a known Ebola case. Malaria is a much more likely cause of your fever, and now that the summer months are approaching, Lassa Fever, another type of Viral Hemorrhagic Fever, is becoming more prevalent.
You go to the local “clinic” and healthcare workers there isolate you. They draw blood and send it to a nearby city for testing. It will take days for the results to come back. You are considered Ebola positive until proven otherwise. Until then, you are put in containment with other febrile patients–some probably with Ebola. There is no space. You are crammed in with other sick patients and isolated from your family. You may feel O.K. compared to these patients, some of whom are potentially deathly ill. If you do not have Ebola now, will you have it by the time your waiting period is done?
Now imagine an alternative reality.
You wake up with the same fever and nausea. You go to a designated diagnostic site, likely the same clinic, and your finger is pricked or a small vial of blood is drawn by a trained healthcare worker. You are asked to wait in a holding room for up to three hours, but no more. Everyone in the room with you is about as sick as you are and waiting quietly and calmly. In a few hours, you have an answer: You have Lassa or Malaria or another febrile illness, or you have Ebola. From there you are triaged appropriately to the best treatment, maybe released with anti-malarial medications or other treatment.
In West Africa today, a rapid diagnostic test (RDT) would be a complete game changer. Identifying infected individuals quickly means the best use of resources, quick institution of appropriate treatment, reduced risk for spread of infection, and decrease in public panic and fear.
On October 25 the FDA approved two tests from BioFire Defense that can produce a diagnosis in two hours compared with current polymerase chain reaction (PCR) methods that generally take four hours. The new tests use patented “FilmArray” technology to identify the virus quickly.
While this is definitely a step in the right direction, it is still not the ideal solution. First, BioFire’s FilmArray tests still require someone to draw an entire tube of blood and inactivate the virus, which is dangerous. Second, the testing instrument can only process one sample at a time. One machine can process 24 tests a day, while PCR tests can run up to 70 tests a day even though they take four hours. Third, the cost is almost prohibitive. The new test instrument costs $39,000 and each test is $189 dollars. Considering multiple devices are needed, and that PCR is relatively cheap, the cost benefit analysis needs to be considered.
This is not to say I am not encouraged by the possible impact of the BioFire technology. I am especially pleased the FDA accelerated approval. But we cannot stop here.
The ideal RDT would be a quick, field-ready test, with results available within hours at a very low cost. It would not require large blood samples, would have a high sensitivity and specificity, and may even be able to detect viral RNA before a patient becomes symptomatic—at very low concentrations—to avoid lengthy quarantines.
Several groups have reached out to me to let me know that they are working to develop such a test. Promising development it happening! When these criteria are met, it will be possible to test in a maximally effective, decentralized, and distributed way.
Until then the wisest course is a coordinated containment strategy for real exposures. The only people that have contracted Ebola in the U.S. have been healthcare workers exposed to the bodily secretions of infected patients late in the disease progression. Our focus should be on people who are truly likely to have been infected. And the treatment strategy should leverage the specific hospitals that are trained in managing diseases like Ebola.
It is hubris to think just anyone in healthcare can take care of Ebola patients and properly contain it. We have to respect the virus. But that does not mean mass hysteria, wide spread travel bans or even airport quarantines. We have to remember the science behind Ebola. It is infectious but not very contagious. It requires that bodily secretions contact mucous membranes.
While mistakes have been made in identifying and containing this outbreak, we must recognize we are fighting a disease and not each other. What we learn as we contain Ebola can be applied to infectious disease challenges in the future—both globally and at home. Today, one out of every 25 people admitted to the hospital in the U.S. acquires an infection and more than 5,000 people die of those infections each month. Early detection of infections in the hospital setting can reduce spread and save lives.
Doing thing right on Ebola will become the standard for how in the future we treat all infectious diseases. We need to keep working to get it right—to make the ideal a reality.