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Immunoassays
Seegene launches 3rd RUO mpox assay
By
LabPulse.com staff writers
After introducing two research use only (RUO) mpox assays in August, Seegene has expanded its mpox assay line with a third RUO assay designed to address the spread of the mpox virus variant clade Ib currently prevalent in the mpox outbreak in Africa.
September 10, 2024
Rapid blood test for heart attack holds promise for shorter ED stays
By
LabPulse.com staff writers
A rapid blood test that can distinguish heart attack in people presenting at emergency departments (EDs) with chest pain has been developed by researchers.
September 5, 2024
New assay developed for persistent African HIV strains
By
LabPulse.com staff writers
A multinational research team has developed a test to measure the persistence of HIV in people who have been infected by strains of the virus found predominantly in Africa, providing a necessary tool in the search for a cure for HIV.
July 9, 2024
CRISPR-based paper test could improve influenza testing access, outbreak surveillance
By
LabPulse.com staff writers
Researchers from the Broad Institute of MIT, Harvard, and Princeton University have developed a low-cost paper strip test that uses CRISPR to distinguish between the two main types of seasonal influenza, A and B, as well as subtypes H1N1 and H3N2.
June 21, 2024
FDA grants 510(k) clearance to Genetic Signature for parasitic GI infection kit
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Genetic Signature's EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated molecular workflow.
June 7, 2024
Roche garners FDA EUA for 4-in-1 respiratory panel
By
LabPulse.com staff writers
Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas Liat SARS-CoV-2, influenza A/B, and RSV nucleic acid test.
June 10, 2024
Diasorin receives FDA 510(k) clearance for fungal infection panel
By
LabPulse.com staff writers
Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Liaison Plex Yeast Blood Culture assay, the second molecular multiplexing panel developed for the firm's Liaison Plex system.
June 6, 2024
University of Florida researchers develop CRISPR-based assay for HPV detection
By
LabPulse.com staff writers
Researchers at the University of Florida have developed a testing method that utilizes CRISPR gene-editing technology to detect HPV in blood or saliva samples that could promote earlier cervical cancer detection.
May 7, 2024
Researchers tweak TB treatment assay to support global use
By
Nick Paul Taylor
Researchers have developed a tuberculosis (TB) treatment assay that could be a faster, simpler method for monitoring patients.
April 10, 2024
BioMérieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By
LabPulse.com staff writers
BioMérieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
CAP releases updated guideline for validation of IHC assays
By
LabPulse.com staff writers
The College of American Pathologists (CAP) has updated its evidence-based guideline for analytic validation of immunohistochemical assays to provide increased accuracy and consistency in laboratory practices.
February 26, 2024
High-sensitivity assay improves diagnosis for patients with heart muscle injury in U.K. study
By
Matt Limb
A high-sensitivity blood test can improve diagnosis for 1 in 5 patients who have a heart muscle injury, according to a U.K. hospital study.
December 6, 2023
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