FDA Clears Sekisui Diagnostics Rapid COVID-19 and Flu A&B Combo Test
The CLIA-waived test detects and differentiates SARS-CoV-2, influenza A, and influenza B from a single nasal swab for point-of-care use.
Category: Covid 19
Covid 19
Latest
Covid 19
Latest
COVID Next: Charting an Evolving Industry
Industry experts predict clinical diagnostics will continue evolving in the wake of COVID with automation, AI, and decentralized testing.
Covid 19
Latest
Scientists Pinpoint Mutations That Supercharged SARS-CoV-2 Spread
Researchers identified key SARS-CoV-2 mutations that increased the virus’ ability to spread via a novel genomic surveillance model.
Medical AI Tool IDs Long COVID from Patient Health Records
Investigators have developed an AI tool to analyze electronic health records, helping clinicians identify cases of long COVID.
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AMP Releases Best Practices Report for SARS-CoV-2 Genomic Surveillance Using NGS Tech
The AMP published a consensus report on best practices for SARS-CoV-2 genomic surveillance using next-generation sequencing (NGS).
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Nasal Swab Tests Can Predict COVID Disease Severity
Nasal autoantibodies can predict COVID severity, providing insights for personalized treatment and applications for other respiratory viruses.
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COVID Variants Flagged By New Software
Researchers developed a new surveillance technique that can detect emerging COVID variants before they become widespread.
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Healgen Scientific Gets De Novo Marketing Authorization for OTC COVID and Flu Test
Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test received FDA De Novo authorization for OTC use.
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New Test System Using Janus Particles Rapidly Detects COVID
The new testing system uses Janus particles to rapidly detect viral proteins, with potential applications extending beyond COVID.
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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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