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Status of Diagnostic reagents for Ebola

1. Reasons why commercial Ebola detection kits are rare

Commercial testing for the Ebola virus is rare, in part because there is very little ongoing investment.

The Democratic Republic of Congo has seen its worst Ebola outbreak since 1976. This is one of the worst Ebola outbreaks the world has ever seen.

However, health workers and organizations trying to stop the outbreak from continuing to expand cannot get in-vitro diagnostic solutions fast enough. Even with international donor funds available to pay for these programs, it can take 2-8 weeks for lab or health center staff to get the tests.

2. There are two types of in vitro diagnostic tests for Ebola

Rapid diagnostic tests detect a viral protein; polymerase chain reaction-based tests identify the genomic material of the virus.

The analysis showed that only a few of the in vitro diagnostic tests offered by companies that were developed and approved during the 2014-16 West African outbreak continued to research and scale up their production.

Diagnosis is the foundation of controlling an outbreak. Without such a test, it would be impossible to track whether a patient infected others, whether the virus was present in survivors, and whether the cause of death would need to be investigated.

Various Ebola diagnostic methods need to be evaluated and the best method prioritized. Most importantly, developers must be encouraged to continue developing diagnostic tools during and after an outbreak to prevent in vitro diagnostic tests from being unavailable when the next outbreak hits.

In August 2014, nearly six months after the Ebola outbreak in West Africa that killed more than 11,000 people, the FDA established an "emergency use authorization" process for Ebola diagnostic tests.

It allows unapproved medical products to be used in emergency situations – to diagnose, treat or prevent serious diseases or conditions when no alternatives are available.

The following month, the World Health Organization launched an emergency use evaluation and marketing process for Ebola test kit to allow faster review of diagnoses in the event of a public health event.

It also calls on manufacturers to develop diagnostics that are easy to use, even on-the-spot, and easy to use in countries that lack health infrastructure and trained personnel to provide rapid test results.

As the outbreak unfolds, researchers, manufacturers and other organizations are working to accelerate the development, evaluation, production and deployment of Ebola test kits.

Health workers in the Democratic Republic of Congo do not need to take the 14 different Ebola tests. What they need is a range of reliable, easy-to-use, PCR-based, and most importantly, a continuous supply of rapid diagnostic tests.

3. Why are there so few stocks and sales of Ebola testing kits provided by approved companies?

That's because developing diagnostics for unpredictable infectious diseases like Ebola is a high-risk strategy for manufacturers. This means that the costs of producing reagents, storing IVD raw materials and final products, and addressing logistical and distribution challenges far outweigh the benefits of sales.

With the end of the Ebola outbreak in West Africa, public concerns about the Ebola virus have subsided, and so has public and private funding available to companies developing Ebola testing kits.

Even in an emergency, companies struggle to get enough samples to evaluate their tests. As fewer and fewer people are infected, it has become more difficult to assess tests in the field and to gain national and local authority to share and ship clinical specimens.

We believe two actions are urgently needed to improve the availability of in vitro diagnostic tests - both in the Congo Ebola outbreak and in future crises.