DiaCarta Monkeypox Test Kit Issued Emergency Use Authorization by FDA

Earlier this month, the US Food and Drug Administration (FDA) issued an emergency use authorization for DiaCarta’s QuantiVirusTM MPXV test kit. The kit is a PCR test for monkeypox virus (MPXV) that tests for two separate regions of the MPXV genome to account for the chance of future mutations that would otherwise render the test void.

According to Laboratory Network, “The high-throughput solution on an open qPCR system allows labs to more easily adopt the test and helps individuals get accurate results quickly, eliminating instances of unnecessary additional testing or isolation and allowing patients to have access to appropriate treatment as soon as possible.”

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(Source: Laboratory Network, January 12^th, 2023)