Co-Diagnostics Begins Clinical Testing for Respiratory Multiplex PCR Test
The company aims to support FDA 510(k) clearance submission for its point-of-care platform detecting flu A/B, COVID-19, and RSV.
Category: Covid 19
Covid 19
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Covid 19
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FDA Clears Hologic’s Aptima SARS-CoV-2 Assay
Hologic, Inc. has received FDA 510(k) clearance for its Aptima SARS-CoV-2 assay, initially authorized for emergency use in 2020.
Covid 19
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Thermo Fisher Gets FDA Clearance for COVID Diagnostic PCR Kit Â
The TaqPath COVID-19 Diagnostic PCR Kit enables labs to adopt a validated in vitro diagnostic workflow for SARS-CoV-2 detection.
Healgen Scientific Opens Houston Facility to Bolster COVID-19/Flu Test Production
Healgen Scientific launched the manufacturing facility to help produce the Healgen Rapid Check COVID-19/Flu A&B Antigen Test.
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The New Era of Respiratory Virus TestingÂ
The landscape of respiratory virus testing has evolved rapidly, driven by burgeoning diagnostic solutions like multiplex testing.
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Routine Lab Tests Can’t Reliably Diagnose Long COVID
A new study found routine lab tests may not effectively diagnose long COVID, underscoring the need for new biomarkers and diagnostic tools.
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Bioelectric Device Quickly Detects Coronavirus Variants
Researchers have developed a bioelectric device using biomembranes to quickly detect and classify harmful variants of coronavirus.
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Fast 3-in-1 Antigen Test for COVID, Influenza Gets EUAÂ
Watmind USA received FDA Emergency Use Authorization for its rapid OCT SpeedySwab Covid + FLU A&B Self-Test.
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The Benefits of Home Testing for COVID Immunity, Booster Decisions
A new study found that at-home antibody tests can effectively detect inadequate COVID immunity, aiding decisions about booster vaccinations.
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FDA Issues Warning Against Using Cue Health COVID Tests
The FDA warned against using Cue Health’s COVID tests due to modifications that reduced test reliability and increased risk of false results.
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iHealth Unveils At-Home Antigen Test for COVID-19 and Flu A&B
iHealth Labs received FDA Emergency Use Authorization for its COVID-19/Flu A&B Rapid Test Kit, enabling quick self-testing at home.
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PeploBio and IncellDX Launch Long COVID Test in the UK
The lab-developed test will help diagnose Long COVID and is aimed to provide accurate insights into personalized treatment approaches.
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QuidelOrtho’s Rapid COVID Test Gets 510(k) Clearance
The COVID test is cleared for those aged 14 or older when self-testing, and those aged two and older when administered by an adult.
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Long-Haul COVID: Blood Test Could Predict Lung Problems
Researchers have discovered a potential way to predict which patients are likely to suffer long-haul COVID and associated lung problems.
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Fibrinolytic Biomarkers Can Identify Patients at Risk of Severe COVID
Researchers found that proteins regulating plasminogen-plasmin levels can be used as biomarkers to identify those at risk or severe COVID.
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Blood Analysis Finds Long COVID Characteristics
Analysis of blood samples from patients with Long COVID has revealed serum protein changes as the likely culprit.Â
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COVID Diagnostic Prototype that Glows Produces Results Quickly
Using a molecule found in crustaceans, researchers developed a rapid approach that detects COVID comparably to one used in vaccine research.
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MaximBio Secures $49.5M Manufacturing Award for Pandemic Testing
MaximBio received a $49.5 million award to help fortify their domestic manufacturing capabilities for potential future pandemic preparedness.
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