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FDA clearance

The assay was cleared and CLIA-waived for use on Quidel's Sofia 2 instrument for the detection of RSV using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens.

The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.

The assay can also be used to assess a broad range of metabolic conditions, including pancreatic tumors, liver disease, acromegaly, and others.  

The fourth-generation assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma.

The assay is the firm homogeneous PCT assay for use on Beckman Coulter AU model chemistry analyzers and can be used to manage bacterial infections and sepsis.

The firm said the automated assay offers labor savings and improved workflow for labs compared to traditional manual testing methods.

QuantiFeron-TB Gold Plus is an immunoassay that detects the release of interferon-gamma as a proxy for latent tuberculosis infection.

The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.

The agency cleared a handful of assays last month for the detection and diagnoses of toxoplasmosis, syphilis, sepsis, thyroid conditions, and other ailments. 

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

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