New Clinical Practice Guideline Recommends FeNO Use for Asthma
A new guideline from the American Thoracic Society recommends the use of fractional exhaled nitric oxide (FeNO) in patients with asthma in whom treatment is being considered.
Category: Testing
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First SARS-CoV-2 Test Granted Marketing Authorization
The FDA granted marketing authorization to the BioFire Respiratory Panel 2.1, the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the COVID-19 public health emergency.
Testing
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FDA Authorized First Over-the-counter COVID-19 Test – Useful But Not a Game Changer
Soon, people in the U.S. will be able to pick up a rapid antigen test for COVID-19 from their local drugstore without a prescription.
FDA Okays First Combo FLU + COVID-19 Diagnostic for Home Testing
The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
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FDA Approves Lucira COVID-19 Self-Test with Rapid Results
The FDA has authorized the Lucira COVID-19 All-In-One Test Kit — the first coronavirus diagnostic for self-testing at home and that provides rapid results.
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Pulmonary Fibrosis: New Recommendations for Genetic Testing
The PFF recommends patients with possible or likely genetic forms of pulmonary fibrosis be considered for genetic evaluation when possible to determine whether genetic testing is appropriate.
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New COVID-19 Assay Can Monitor Vaccine Responses
Leinco Technologies has developed a proprietary, fully validated assay: the COVID-19 ImmunoRank Neutralization MICRO-ELISA test.
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FDA Authorizes First COVID-19 Test Where Results Can Be Read Directly From Testing Card
The BinaxNOW COVID-19 Ag Card is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
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Michigan Instruments Supplying Lung Simulators for COVID-19 Ventilator Development
Michigan Instruments has delivered lung simulators to help in research and ventilator development to combat the shortages caused by the COVID-19 pandemic.
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FDA Authorized Six Additional COVID-19 Tests This Week
As of Aug 13, 2020, the FDA has now authorized 213 COVID-19 tests under emergency use authorizations.EUAs, including 174 molecular tests, 37 antibody tests, and 2 antigen tests.
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FDA Authorizes GWU SARS-CoV-2 Test
The FDA issued an emergency use authorization for the GWU SARS-CoV-2 RT-PCR Test to George Washington University’s Public Health Laboratory.
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Ventilators: Make the Time for Testing and Calibration
Despite innovation and advancements in modern ventilator management, it’s still essential for clinicians to know that the information they provide is accurate.
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Hans Rudolph Develops Testing Kit to Aid COVID-19 Ventilator Demand
Hans Rudolph Inc has developed a Ventilator Testing Kit that incorporates the company’s SmartLab Data Acquisition System and other Hans Rudolph respiratory testing components.
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FDA Authorizes ‘Pooled’ COVID-19 Testing for up to Four Samples
The FDA authorized a Quest Diagnostics COVID-19 test for “pooled” samples, allowing four people to be tested with one assay.
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FDA Clears Nonin’s Handheld CO-Pilot Device for EMS
Nonin Medical’s CO-Pilot is a handheld device with wireless capabilities that helps EMS, firefighters and military personnel measure patient parameters following cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
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