Roche Receives FDA Clearance for Point-of-Care Bordetella Test
The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.
Category: POC Rapid Assays
POC Rapid Assays
Latest
POC Rapid Assays
Latest
bioMérieux Acquires SpinChip Diagnostics
bioMérieux has acquired SpinChip Diagnostics ASA, which has a POC immunoassay platform capable of delivering results within 10 minutes.
POC Rapid Assays
Latest
FDA Grants InBios First Marketing Rights for Anthrax POC Test
InBios has been granted the U.S. Food and Drug Administration’s (FDA) first marketing rights for an anthrax point-of-care (POC) test.
Virax Biolabs Introduces Monkeypox Antigen Rapid Test Kit
Virax Biolabs announced the distribution of its Monkeypox Virus Antigen Rapid Test Kits, now launched in markets accepting the CE mark.
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August/September 2022 Tech Guide: Point-of-Care Assays and Analyzers
The August/September 2022 Tech Guide that appears in CLP features a wide-range of products from top laboratory providers.
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De Novo Submission Made for Flu Molecular Test
Cue Health has made a de novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue Flu Molecular Test.
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Media Pooling Strategy Added to SARS-CoV-2 RT-PCR Test
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 has the additional capability to be used for pooling, using a three-in-one media pooling strategy.
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Accurate Rapid Test for Viruses Developed by UT Dallas Researchers
Researchers have developed an accurate rapid test for viruses that can deliver lab-quality test results within 30 minutes.
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GS Labs Reopens COVID Testing Site to Meet Demands
GS Labs offers rapid antigen tests, PCR tests, Rapid PCR and LAMP tests, and a combination rapid antigen COVID and flu tests.
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Optical Method for Rapid COVID Detection Obtains 100% Sensitivity
A new method has obtained a sensitivity of 100% and a specificity of 87.5% in the detection of SARS-CoV-2 in nasopharyngeal exudate from symptomatic people.
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Handheld COVID Breathalyzer Could Allow Mass Screening in Public Spaces
Researchers developed a prototype, handheld “breathalyzer” that can sensitively and accurately diagnose COVID-19 in less than 5 minutes.
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COVID Control: How Northeastern University Built an In-House Testing Lab from Scratch
Boston-based Northeastern University fully reopened in Fall 2021 thanks to a rigorous COVID testing program and an in-house laboratory.
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Biden outlines new Omicron strategy, will order 500 million at-home tests for Americans
President Joe Biden outlined a new plan to combat the surging Omicron variant, including a plan to deploy millions of at-home tests.
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Saliva May Be an Easier Alternative for Rapid COVID-19 Tests
A new study on rapid COVID-19 testing is investigating whether a saliva-based rapid antigen testing is more effective than the more common PCR tests.
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FDA Authorizes Additional Indication for BinaxNOW COVID-19 Self Test
The FDA reissued the EUA for the BinaxNOW COVID-19 Antigen Self Test as a single test without a prescription for people with COVID-19 symptoms.
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FDA Grants Emergency Use Authorization for Rapid SPERA COVID-19 Ag Test
The FDA has issued an EUA for the SPERA COVID-19 Ag Test, a rapid lateral flow immunoassay from Xtrava Health designed for use at the point of care.
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LumiraDx’s COVID-19 Antigen Test Expanded to Include Screening of Asymptomatic Individuals
LumiraDx announced that the intended use for its FDA EUA-authorized SARS-CoV-2 Antigen Test has been expanded to include asymptomatic individuals.
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Strategic COVID-19 Testing Could Prevent Distancing, Shutdowns
Making diagnostic tests for SARS-CoV-2 faster or more available could reduce reliance on costly interventions, such as distancing and shutdowns.
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