Ebola tests sold to Denmark recalled

The US Food and Drug Administration said that Ebola kits sent to Denmark and other countries could result in "life-threatening" false positives.

Ebola tests sold to Denmark recalled
Photo: Colourbox
US regulators have issued an international recall for a 10-minute Ebola blood test made by a California-based company, saying it has not been proven to work and could put lives at risk.
"A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale," said the Food and Drug Administration in a statement emailed to reporters on Thursday.
"The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection."
The recall was initially issued in mid-March and applies to test kits exported to Denmark, Sierra Leone and Canada between October 2014 and January 2015.
The FDA did not say how many tests were sent out.
The recall is described as a Class I, "the most serious type of recall and involve(s) situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," the FDA said.
"A false positive result may be life-threatening by potentially placing the patient in an isolation cohort with Ebola-infected patients."
Contacted by AFP, a company representative in San Diego said early trials have shown the test to be 86 percent accurate.
The problem with the FDA came down to a labeling error, he said. The equipment had not been properly labeled "for research purposes only."

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Thorning to visit Ebola workers in Sierra Leone

Danish PM's trip to "show support and solidarity" will mark the first time a Western leader has travelled to Sierra Leone since the outbreak of Ebola.

Thorning to visit Ebola workers in Sierra Leone
Thorning-Schmidt will visit Sierra Leone on Monday. Photo: Keld Navntoft/Scanpix
Denmark's Prime Minister Helle Thorning-Schmidt begins a visit to Sierra Leone on Monday, making her the first Western leader to travel to the African nation since it was hit by a deadly Ebola outbreak.
The epidemic "can only come under control if we help each other. It is a long and persistent struggle that we cannot forget in our part of the world," she told Berlingske.
"It is important that countries like Denmark show support and solidarity with Sierra Leone and other west African countries affected by Ebola," she said.
Thorning-Schmidt will visit a group of 19 Danish healthcare workers who were sent to the northeastern town of Port Loko in December to work at an Ebola treatment centre.
She will also visit a Danish transport ship used to bring UN vehicles into Sierra Leone, Liberia and Guinea.
The three countries account for 99 percent of the estimated 8,500 Ebola deaths out of more than 21,000 cases reported since December 2013, according to the latest World Health Organization report.
The UN's Ebola coordinator David Nabarro said Thursday the crisis has "passed the tipping point" and there is now a reasonable chance the deadly outbreak could end quickly.
Liberia reported its lowest weekly number of new cases since early June, while Guinea and Sierra Leone both saw the fewest new cases since August, Nabarro said in his most recent update.