Alere secures IVD CE mark for Alere Reader

9 August 2016 (Last Updated August 9th, 2016 18:30)

US-based diagnostics company Alere has obtained the in-vitro diagnostic (IVD) CE mark in Europe for its new Alere Reader, a diagnostic analyser.

US-based diagnostics company Alere has obtained the in-vitro diagnostic (IVD) CE mark in Europe for its new Alere Reader, a diagnostic analyser.

The device has been designed to be used with both point-of-care and laboratory settings.

The physicians, lab technicians and other healthcare personnel can insert test cards into the Alere Reader at the read time which then detects, identifies and examines the completed lateral flow assay.

"By ensuring the accuracy of test results, no matter who interprets them, the Alere Reader helps support key goals of regulatory and health stakeholders."

The Alere Reader features an intuitive touch screen which displays the results of the test card inserted.

The results can be immediately connected to patient electronic medical records and back-end information systems, or can be printed.

Additionally, the device features an automated function which further validates the quality control run on the results, thereby instilling confidence in the users.

Alere infectious disease global president Avi Pelossof said: "The Alere Reader improves what is already a leading rapid testing solution for community-acquired pneumonia (CAP) in Europe in two key ways: by eliminating operator subjectivity and by instantaneously connecting BinaxNOW test results with laboratory and hospital information management systems.

 "By ensuring the accuracy of test results, no matter who interprets them, the Alere Reader helps support key goals of regulatory and health stakeholders; in addition, by utilising the Alere Reader at the point-of-care, providers can obtain the most accurate results within an actionable timeframe so they can administer the right treatment quickly.

"We are committed to populating the Alere Reader with a comprehensive menu of rapid tests so these benefits can be experienced in any setting where expedient and accurate tests are demanded."

The company is planning to add extra assays designed to detect respiratory and healthcare associated infections to the Alere Reader menu.