WebAlinity m is a fully integrated and automated molecular diagnostics analyzer that uses innovative technology to deliver the next level of flexibility and efficiency to your lab. We surveyed health systems and labs around the world to develop the Alinity m to meet your needs, now and into the future. SPECIFICATIONS WebBackground: Viral load (VL) determination is an essential parameter of the management of patients infected with HIV, HBV or HCV. Many available molecular systems run on a …
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Webdna probe, nucleic acid amplification, chlamydia - Abbott Realtime CT; Alinity m STI Amplification Kit, Alinity m STI Control Kit; Alinity m STI Application Specification File ... genotyping, hepatitis c virus - Abbott RealTime HCV Genotype II Amplification Including Uracil-N-Glycosylase (UNG) 08L21-066, 6L87-02; Abbott RealTime HCV Genotype II ... WebNov 1, 2024 · Results. The dilution panel suggested that the Alinity m DBS assay is one log more sensitive than our current DBS HCV RNA assay. Mock DBS demonstrated 100% specificity, and 100% sensitivity for samples with plasma HCV RNA viral loads > 2.7 log 10 IU/mL, however four samples with viral loads between 1.3 and 2.4 log 10 IU/mL were not …
WebU.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.13 Silver Spring, MD 20993 www.fda.gov Abbott Molecular, Inc. Elina Arroyo Regulatory Affairs Manager 1300 E. Touhy Avenue Des Plaines, Illinois 60018 Re: P190025 Trade/Device Name: Alinity m HCV Product Code: MZP Filed: September 30, 2024 … WebMay 12, 2024 · The FDA cleared the Alinity m system for use with Abbott’s HCV (hepatitis C) assay in late March. Abbott said it is working with hospitals and health systems in the U.S. to install this new ...
WebApr 27, 2024 · The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. WebJul 19, 2024 · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP: Product: The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. Code Information: Serial Number 00654: Recalling Firm/ Manufacturer: Abbott Molecular, Inc. 1300 E Touhy Ave Des Plaines IL 60018-3315
WebMar 5, 2024 · Assays available for use on the Alinity m system worldwide include: SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR HPV. The easy-to-use system will help to improve laboratory workflow and efficiency with its large capacity and fast turnaround time, being able to run …
The Alinity m HCV is a laboratory test used to help diagnose people who currently have hepatitis C virus (HCV) infection. It is a molecular test (RT-PCR assay) that detects the amount of ribonucleic acid (RNA) from HCV found in the patient’s blood sample. See more A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood is inserted into the the Alinity m Instrument, where the RNA is separated from the blood and … See more This lab test should not be used to screen blood donors because FDA has not licensed it for this purpose. See more The Alinity m HCV is used when doctors want to determine whether a patient has current HCV infection. The test is also used when a doctor … See more The test helps doctors diagnose a current (active) HCV infection and manage the treatment of patients who are going through HCV treatment. See more toyland monctonWebSTN: 125677. Proper Name: Hepatitis C-virus Encoded Antigens (Recombinant c100-3, HCr43) Tradename: Alinity s Anti-HCV. Manufacturer: Abbott GmbH & Co. KG. … toyland movie youtubeWebMay 1, 2024 · A workflow analysis of 1,068 samples compared turnaround times (TATs) on five m2000 systems and one Alinity m system running Alinity m HIV-1, HCV, HBV, HR HPV, and STI assays. The Alinity m assay system demonstrated high detectability and precision at clinical decision points and excellent correlation with Abbott RealTime assay … toyland movie 1961WebMay 4, 2024 · Alinity m systems are designed to be more efficient – running more tests in less time and minimizing human errors – while continuing to provide quality results. The … toyland ms2WebThe Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in … toyland movie cartoonWebThe Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System for the detection of DNA from 14 high-risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while ... toyland movie 1934WebMay 4, 2024 · About Alinity m. Assays available for use on the Alinity m system in the U.S. include: SARS-CoV-2 (Emergency Use Authorization), Resp-4-Plex (Emergency Use … toyland music box