Testing integrates the Spectrum Solutions saliva self-collection system with a new, advanced multiplex qPCR platform for the simultaneous RNA detection of covid-19 and its viral mutations, as well as Influenza A, B, and more.
The panel tests nasopharyngeal swabs for the most common respiratory viruses and bacteria.
Hologic has received FDA premarket notification (510(k)) clearance for its Panther Fusion Paraflu assay, a multiplexed assay that runs on the company’s new Panther Fusion system.
The system was specifically developed to enable decentralized sample processing, while the resulting data can be stored and analyzed centrally anywhere in the world.
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The NxTag respiratory panel from Luminex enables laboratories to detect 20 respiratory pathogens simultaneously in a single closed-tube system.
Read MoreCLIA-waived test promises the accuracy of reference laboratory tests for performance at the point of care.
Read MoreThe closed-tube, scalable, 96-well based system from Luminex seeks to meet clinical demand for respiratory disease testing.
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Following best practices can help labs maximize the utility and cost-effectiveness of flu testing.
Read MoreAccording to US Centers for Disease Control and Prevention, a comprehensive and timely overview of influenza activity is an essential public health activity for a variety of reasons.
Read MoreOver time, the American Medical Association has established specific current procedural terminology codes to be used in reporting the results of testing by means of such multiplex molecular pathology panels.
Read MoreWhile viral culture is very sensitive, its long turnaround time, high cost, and requisite skill have made the method obsolete in most laboratories throughout the United States.
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Flexible panel testing is the latest of many advances for the field.
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Developed by Focus Diagnostics, the test is cleared to identify 92 influenza and respiratory syncytial virus strains.
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The Cobas Liat test is the first CLIA-waived real-time polymerase chain reaction test to detect influenza A and B in approximately 20 minutes.
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FDA has granted a Clinical Laboratory Improvement Amendments waiver to the Alere i Influenza A & B test, the only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes, and now the first molecular test to receive a CLIA waiver.
Read MoreA new reflex test from LabCorp identifies the presence of enterovirus D68, which can lead to serious respiratory tract infections requiring hospitalization, particularly among pediatric patients with asthma. More than 1,100 cases have been reported in the United States since August 2014. There are currently no known vaccines or treatments.
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The Simplexa Flu A/B & RSV Direct kit from Focus Diagnostics, Cypress, Calif, has received FDA clearance for eight additional influenza strains, including H3N2v and the novel avian influenza A strain H7N9.
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CLP’s October 2014 Tech Guide features a range of flu and respiratory virus testing products from vendors such as Alere, Quidel, and Randox.
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