CLN Article

CE Mark Given to Atomo Diagnostics’ Integrated HIV At-Home Test

Regulatory Roundup: December 2017

The Australian medical device company Atomo Diagnostics has earned the CE mark for its Atomo HIV Self Test. Designed for at-home use, this test consists of a third-generation HIV test strip integrated into a handheld device along with a sterile safety lancet and a blood collection and delivery system designed to eliminate user errors. The test strip uses rapid, lateral flow immunoassay technology to detect antibodies to HIV types 1 and 2 in human whole blood. To perform the test, users place a small drop of capillary blood from a fingerprick onto the test strip, and then apply drops of chase buffer. Within 15 minutes, a control line becomes visible on the strip to indicate that the test has worked. A second test line will also become visible if the applied sample contains HIV antibodies. Independent studies found that, when used by untrained individuals in the field, the Atomo HIV Self Test demonstrated 100% concordance with laboratory results.

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