May 2010: Volume 36, Number 5
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CLIA-Waiver Status Granted for Coaguchek |
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The Coaguchek XS-Plus system has been granted CLIA-waived status by the FDA, allowing the point-of-care anticoagulation monitor to be used in more clinical settings. The system, manufactured by Roche Diagnostics, provides healthcare professionals with connectivity and data management tools that help with testing of PT/INR, or blood clotting time. The CLIA-waiver status exempts the Coaguchek from most rules instated by CLIA, which means lower qualifications for those involved in administering or supervising the test. Recent updates to Coaguchek include the ability to hold the results of up to 1,000 patients, and only needing a sample size of 8 µL from each patient.
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Moderate Complexity Categorization for Nanosphere's Virus Panel |
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FDA has given Nanosphere’s respiratory virus panel, RVNATSP performed on the Verigen SP System, a moderate complexity categorization under CLIA standards, allowing the panel to be run in more settings by a broader group of operators. Previously, the panel had a high complexity designation on the original Verigen platform. The benchtop molecular diagnostics workstation uses the company’s patented gold nanoparticle technology to detect nucleic acid and protein targets. The updated Verigen SP platform has automated sample preparation, providing sample-to-result capability on one device.
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Tests for Fungal Detective Receive Clearance |
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The FDA has given 510(k) clearance to a new protocol for AdvanDX’s PNA Fish tests that detect C. albicans and C. glabrata, hospital-acquired Candida infections. The new protocol speeds up results of the tests from 2.5 hours to 90 minutes. The decrease in waiting time can help physicians make decisions more rapidly about course of treatment and also help identify the correct treatment to administer, resulting in cost-effective drug usage.
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H1N1 Test Given Emergency Use Authorization Status |
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IntelligentMDx’s test for the 2009 H1N1 virus has been granted emergency use authorization until April 26, 2010, the expiration date for the public health emergency. The authorization of the Influenza A H1N1 Real-Time RT-PCR Assay includes its use with Applied Biosystems 7500 system, 7500 Fast Real-Time PCR Systems, and the 7500 Fast Dx Real-Time PCR systems.