Improved Ebola IVD Tests Continue to Face Challenges

A new Ebolavirus test provides significant advantage over the current diagnostic pathway, yet there is little justification to establish permanent, advanced testing at expense of more pressing needs.

The new Ebolavirus test, Improved Ebola Diagnostic, developed by the UK’s Defence and Science Technology Laboratory (DSTL) is a step forward and provides significant advantage as it can be carried out at point-of-care (POC) and uses a much smaller sample of capillary blood. However, there remains a need for low-cost, POC testing devices that overcome the logistical and geopolitical obstacles presented by Sub-Saharan Africa, according to Andrew S. Thompson, PhD, senior analyst covering in vitro diagnostics (IVD) at research and consulting firm GlobalData (London, UK).

“By performing the test at the patient’s bedside, the risks of exposure, through transport to a laboratory, are minimized. It needs no specialist equipment and requires very little training, which reduces the diagnostic load on the pathology laboratory, freeing up capacity for confirmatory testing,” said Mr. Thompson.

“However, while the test was shown to be very successful in diagnosing patients admitted to hospital, and who were therefore symptomatic for Ebola, no such testing was carried out on asymptomatic patients in a non-hospital setting.” Furthermore, because viruses such as Ebola generally result in transient outbreaks in poverty-stricken regions, there is little justification to establish permanent, high-grade, molecular diagnostic testing if it comes at cost to more pressing and basic healthcare needs.

“The present Ebola outbreak is the largest known in history, but it is difficult to predict, once it subsides, if such repeated large-scale casualty events will occur again. In any case, Ebola is just one of many emerging, highly pathogenic viruses affecting Sub-Saharan Africa,” said Mr. Thompson, “For now, new tests such as DSTL’s Ebola lateral flow assay, based on long-established and mature technology, remain the best point-of-care testing for rare and emerging infectious diseases. However, in the longer term, these are likely to be overtaken by miniaturized nucleic acid-detection platforms, which can truly bring the gold standard of testing out of the laboratory.”

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