Respiratory Infection: Page 2

PerkinElmer receives EUA for respiratory SARS-CoV-2 panel
By LabPulse.com staff writers
Qualified laboratories can immediately begin using the RT-PCR test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) isolated from nasopharyngeal swabs, anterior nasal swabs, and midturbinate swabs, the company said.
October 6, 2021
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
Lumos touts cost savings for point-of-care infection test
By LabPulse.com staff writers
FebriDx is a finger-stick blood test that distinguishes bacterial from viral acute respiratory infections. The study, published September 30 in the Journal of Health Economics and Outcomes Research, found that FebriDx had a sensitivity of 95% to detect bacterial infections and a negative predictive value of 99% to rule out these infections.
October 6, 2021
2021 10 06 22 07 0734 Antibiotics Concept 400
Ortho launches IL-6 reagent pack
By LabPulse.com staff writers
Conditions that can be targeted by the test include autoimmune disorders, sepsis, severe respiratory infections from COVID-19, and community-acquired pneumonia in critically ill patients.
July 22, 2021
2020 06 18 17 24 6922 Immunoassay Analysis 400
Ink dries on Hologic's deal to buy Mobidiag
By LabPulse.com staff writers
Mobidiag's product line includes molecular diagnostic instruments and tests for acute care conditions, including gastrointestinal and respiratory infections, antimicrobial resistance management, and healthcare-associated infections, according to a release.
June 16, 2021
2019 02 01 17 54 2200 Hologic Rsna 2018 400
Hologic acquires Mobidiag for $795M
By LabPulse.com staff writers
The deal includes a cash payment of approximately $714 million for Mobidiag's equity and net debt of approximately $81 million.
April 7, 2021
2019 08 20 21 43 1377 Hologic Aacc 2019 400
Qiagen secures EUA for COVID-19 test
By LabPulse.com staff writers
NeuMoDx Flu A-B/ respiratory syncytial virus (RSV)/SARS-CoV-2 Vantage is a polymerase chain reaction (PCR) assay that will enable clinicians to identify the cause of respiratory viral infection, whether it's due to SARS-CoV-2, influenza, or RSV.
March 28, 2021
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
FDA authorizes Quest's combined COVID-19 and flu RT-PCR test
By LabPulse.com staff writers
The kit is available for prescription use with Quest's Self-Collection Kit for COVID-190 + Flu by individuals suspected to have respiratory viral infection consistent with COVID-19 when their healthcare provider deems home collection to be appropriate, according to the FDA. After collecting their sample at home, patients can ship it to a Quest laboratory for analysis.
December 7, 2020
2016 09 02 09 36 05 93 Fda Logo V2 400
Quidel gets EUA for combo flu, COVID-19 test
By LabPulse.com staff writers
The ABC Test, also known as the Sofia 2 Flu + SARS Antigen FIA, is a cartridge-based, point-of-care diagnostic that works with both nasopharyngeal and nasal swab specimens. The test is designed for use in individuals with suspected respiratory viral infection within five days of symptom onset, according to the company.
October 5, 2020
2020 06 15 18 14 5259 Swab Sample Collection 400
GenMark releases new rapid respiratory infection panel test
By LabPulse.com staff writers
The company's ePlex Respiratory Pathogen 2 (RP2) panel is now available in the U.S. for distribution and use. Earlier this month, GenMark requested an emergency use authorization for the panel with the U.S. Food and Drug Administration.
June 28, 2020
2020 06 29 16 41 7549 Pathogenic Bacteria Viruses 400
Diagnostics wanted for emerging infections, tomorrow's pandemics
By Bruce Carlson
In a 2018 global IVD market report, Kalorama Information lead analyst Shara Rosen wrote that the dark side of globalism is the spread of unwanted conditions. There are many examples of previously unknown or rare pathogens that spread and became a major problem globally -- this can happen rapidly with people traveling by air throughout the world, Rosen noted.
June 18, 2020
2019 08 08 22 40 7691 Carlson Bruce Aacc 2019 400
Quidel builds point-of-care respiratory infection panel with BARDA cash
By LabPulse.com staff writers
The funding will support the development of a point-of-care diagnostic assay that tests for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. The respiratory virus panel would run on Quidel's Sofia 2 flagship instrument.
June 11, 2020
2019 08 05 19 10 8249 Dollar Sign 400
Sekisui secures FDA clearance, CLIA waiver for rapid flu antigen test
By LabPulse.com staff writers
Utilizing traditional lateral flow technology, the test kit is designed for qualitative detection of influenza type A and type B nucleoprotein antigens from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The company noted the importance of being able to rule flu in or out in the process of assessing patients for other respiratory infections during the COVID-19 pandemic.
June 8, 2020
2020 06 09 23 04 8474 Seksui Osom Ultra Plus Flu Test (1) 400
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