Health Alliance Validates Bird Flu Test for Outbreak Preparedness
The Health Alliance validated a bird flu PCR assay for human diagnostics, a tool for early detection of avian influenza outbreaks.
Category: Immunoassay Reagents & test Kits
Immunoassay Reagents & test Kits
Latest
Immunoassay Reagents & test Kits
Latest
Sysmex Expands Sale of Reagents for Alzheimer’s Testing to Europe
These reagents, the HISCL β-Amyloid 1-42 and 1-40 assay kits, have attained CE-IVD marking as of May 17, 2022.
Immunoassay Reagents & test Kits
Latest
T2Biothreat Panel FDA 510(k) Submission Announced
T2 Biosystems, Inc.,has submitted a 510(k) premarket notification to the FDA for the Company’s T2Biothreat Panel.
Dissecting Limitations and Challenges of Mpox Testing
Clinical labs learned about the limitations of mpox testing during last summer’s outbreak, taking away valuable lessons.
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Your Expired COVID Test Kits Might Still Be Good. Here’s How to Find Out
Americans who are still in possession of COVID tests they acquired earlier in the year may wonder whether or not the tests have expired.
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Thermo Fisher’s Monkeypox Test Gets FDA Emergency Use Authorization
The FDA granted Emergency Use Authorization (EUA) for Thermo Fisher Scientific’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit.
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PerkinElmer SCID-SMA Kit Gets FDA Authorization
PerkinElmer has announced that the FDA has authorized the marketing of the EONIS SCID-SMA assay kit for the diagnosis of SMA and SCID.
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The Native Antigen Company’s Range of Omicron Antigens Now Includes BA.5 Variant
The Native Antigen Company announced the launch of its latest SARS-CoV-2 antigens for the newly designated omicron BA.5 variant.
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Hologic Gets BARDA Contract to Support IVD Approval of COVID Assays
Funding will bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Aptima SARS-CoV-2 assay in line with the FDA’s IVD standards.
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Monkeypox Diagnostic Testing Launched by US BioTek
US BioTek Laboratories is now offering Monkeypox Diagnostic Testing, utilizing a lesion swap specimen and RT-PCR testing.
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FDA Authorizes Quest Diagnostics’ Monkeypox Test for Emergency Use
Quest Diagnostics received emergency use authorization (EUA) from the U.S. FDA for it’s lab-developed Monkeypox virus test.
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Immunoassay Tech Developer Unveils SARS-CoV-2 Neutralizing Antibody Test Kit
Protein detection platform developer, Spear Bio, unveiled its first product to market: the NAB-Sure SARS-CoV-2 neutralizing antibody test kit.
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Siemens Healthineers Brings Millions of Rapid COVID Tests to Market
R.R. Donnelley & Sons Co., a supply chain solutions provider, supported Siemens Healthineers to accelerate delivery of rapid COVID self-tests.
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MicroGEM & Medline Partner to Equip Healthcare Providers with Saliva Point-of-Care PCR Tests
MicroGEM announced that Medline is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.
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Spear Bio’s NAB-Sure Test Kit Aids Analysis of COVID Immune Response
The NAB-Sure SARS-CoV-2 Neutralizing Antibody Test Kit helps researchers better understand COVID immune response and validate vaccines.
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GenScript Responds to Monkeypox Health Emergency with Real-Time PCR Test
GenScript USA, a subsidiary of GenScript Biotech Corp., announced the immediate availability of a monkeypox virus PCR test kit.
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FDA Approves VENTANA MMR RxDx Panel
The U.S. Food and Drug Administration (FDA) has approved a label expansion for Roche’s VENTANA MMR RxDx Panel.
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Meridian’s SARS-CoV-2 Molecular Assay Gets FDA Re-Authorization
Meridian Bioscience received re-authorization from the FDA of its Emergency Use Authorization (EUA) for a SARS-COV-2 molecular assay.
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