3rd ed. Ancillary wash buffer is added and incubated. For instructions on performing a calibration, refer to the Alinity s System Operations Manual, Section 5.Three replicates of Alinity s Anti-HCV II Calibrator 1 are automatically tested by the system. Alinity m benefits from this legacy and commitment to high quality assay development. 1, 2 About 30% of infected individuals resolve their infection, which is characterized by continued detection of antibodies to HCV, but with HCV RNA no longer being detectable. US Department of Health and Human Services. We gathered the pros' top secrets. CI = Confidence IntervalHemoglobin levels of cadaveric serum specimens ranged from 37 to 902 mg/dL.b Cadaveric serum specimens were collected up to 25.5 hours after death.c Hemoglobin levels of cadaveric EDTA plasma specimens ranged from 10 to 210 mg/dL.d Cadaveric EDTA plasma specimens were collected up to 24.5 hours after death.Refer to the SPECIMEN COLLECTION AND PREPARATION FORANALYSIS, Specimen Storage section of this package insert for the maximum storage times allowed. Providing true randomaccess and STAT prioritization, Ability to manage the majority of routine PCR tests on a single platform, Driving standardization through simple, universal design elements, Delivering on the Abbott legacy of high-quality product designs and assays. Please read this instruction carefully before, lSPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS, PERFORMANCE CHARACTERISTICS OF CADAVERIC SPECIMEN TESTING, Abbott Cardiomems Patient Electronics System Instructions, http://www.who.int/news-room/fact-sheets/detail/hepatitis-c, SCT RC7-PD2 Camera Extension Kit for Poly Director II User Guide, VAPORESSO Luxe II 220W Starter Kit User Manual, beurer IL 35 Infrared Lamp Instruction Manual, KEMOT SER-1000 Automatic Voltage Regulator Owners Manual, GEARLAB 5-port Gigabit Nano switch User Manual, Scx Design W1630L 10W Wireless Charging Phone Stand Bamboo Instruction Manual, POLAR GE959 Portable Air Conditioning Unit Instruction Manual, AUKEY EP-T25 Wireless Earbuds User Manual, mifo S ANC TWS Bluetooth Earphone User Guide, SATECHI X3 Bluetooth Backlit Keyboard User Manual, Whirlpool Side-by-Side Refrigerator User Guide, PowerXL Cordless Iron & Steamer User Guide. 2020 Abbott Laboratories. Abbott Point of Care has identified an issue with the recently released i-STAT Alinity product software, version OSi15(A-500.3.35.-1). With the volumes of blood tests conducted each day, people might consider the process to be simple or routine. Reactive specimens were evaluated by calculating the percent differences between the mean S/CO of Day 0 and the mean S/CO of each storage condition and related timepoint. b The following risk factors were diagnosed or treated for HIV, sexual contact with HIV-infected individual, hemodialysis patient, high-risk sex behaviors, history of incarceration, illicit drug use (intravenous or intranasal), intranasal cocaine user, intravenous drug user, men who have sex with men, multiple sex partners, occupational exposure, tattoo, body piercing or acupuncture, persons with known exposure to HCV, and transfusion recipient (received transfusion prior to July 1992 or received a transfusion from HCV positive donor). 3 days If specimens are not processed directly after initial centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing. Nonreactive specimens were evaluated by calculating the differences between the mean S/CO of Day 0 and the mean S/CO of each storage condition and related timepoint. Acute viral hepatitis. Abbott Announces Fda Clearance For Its Alinity Ci-Series Next www.hhmglobal.com. The system does not provide the capability to verify specimen types. To prevent cross-contamination, the use of disposable pipettes or pipette tips is recommended. Center for Disease Control. Perform any test, any time, including STAT samples, Consistent throughput regardless of assay mix. The low-level reactive specimens were prepared by spiking 10 nonreactive cadaveric serum specimens and 10 nonreactive cadaveric EDTA plasma specimens to a target S/CO value near the cutoff with human plasma reactive for anti-HCV. Alinity m delivers true random access; continuous loading for samples, reagents, commodities and access to waste; fast time to first result; and high throughput. Abbott molecular, abbott park, il. WBC, red blood cells (RBC), hemoglobin (HGB), and platelets showed good linearity and acceptable carry-over. Abbott, Abbott Park, Ill, has announced that its Alinity m molecular diagnostics system and assays have received the CE mark. Alinity m delivers true random access; continuous loading for samples, reagents, commodities and access to waste; fast time to first result; and high throughput. Take for instance the new i-STAT Alinity System from Abbott, a fast and efficient with-patient testing technology that provides lab-quality blood testing results within 2-10 minutes. A. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. %CV = Coefficient of Variation expressed as a percentage; N = Number of Replicates; NA = Not Applicable: %CVs are not meaningful when S/CO approaches zero; SD = Standard Deviationa Includes within-run, between-run, and between-day variabilityb Includes within-run, between-run, between-day, between-site, between-lot, and site-lot interaction variability. Total %CV values were determined. The Alinity m System is a fully integrated and automated molecular diagnostics analyzer which utilizes real-time PCR technology. However, behind the scenes, the process of developing those . 4th ed. To minimize the effects of evaporation, verify adequate sample cup volume is present prior to running the test. All specimens must be tested or retested within 48 hours of initial centrifugation. This test is not intended for use as an aid in the diagnosis of infection with HCV. Instruct patients to keep their patient information guide handy at all times. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. World Health Organization. To . The test, called the Alinity m MPXV test, uses lesion swab specimens from individuals suspected of . Performance has not been established for the use of umbilical cord blood or bodily fluids such as urine, saliva, semen, amniotic fluid, cerebrospinal fluid, or pleural fluid. It is an automated platform, which can run more tests in less . In 10 panels, the 2 assays were reactive within 1 bleed. Hepatitis C virus (HCV) is the causative agent of acute and chronic hepatitis infection. Abbott Laboratories is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott Laboratories. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. Discard after 15 days. Less commonly, HCV is transmitted through blood transfusion, sexual or perinatal routes or contact with contaminated personal items. Phone: (877) 696-3754 Email us Heart Failure Technical Services Pulmonary Pressure Monitoring Phone: (844) 692-6367 Mechanical Circulatory Support (MCS) Phone: (800) 456-1477 Alinity and related brand marks are trademarks of Abbott. Continue with Recommended Cookies, Home Abbott Abbott Alinity s Anti-HCV II Reagent Kit Instruction Manual, Anti-HCV II Reagent Kit enAnti-HCV II04W56H14970R01B4W5G004W5660. Abbott Laboratories recognizes the importance of incorporating cybersecurity considerations early and throughout our product design and development process. The website that you have requested also may not be optimised for your screen size. If the release control does not meet specifications, refer to the Alinity s System Operations Manual, Section 10, for additional information. 2014;61(1 Suppl):S45-57. The i-STAT Alinity was built on the proven technology of the i-STAT 1 System, and is an easy-to-use, portable blood analyzer that delivers real-time, lab-quality diagnostic test results.The i-STAT Alinity's award-winning design features a more intuitive interface that simplifies the testing process even further, allowing for minimal operator training. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies. 1, 2Anti-HCV assays are used to identify individuals infected with HCV and to prevent transmission of the virus to recipients of blood or blood products. Printed copies are free of charge and will arrive in approximately 3 to 7 days. Each specimen was tested once using each of 3 lots of Alinity s Anti-HCV II Reagent Kit. The unit of measure for the product of RCF ( g) and centrifugation time (minutes). Each specimen was tested once, within 24 hours of spiking, using each of 3 lots of the Alinity s Anti-HCV II Reagent Kit.All specimens were reactive on all 3 reagent lots. SensitivityA total of 807 specimens from the categories shown in the table below were tested using Alinity s Anti-HCV II assay at 3 clinical sites. Patented Atellica Magline Transport: rapid, bidirectional, variable-speed sample transport that gives independent control over every sample, including STATs, pediatric, and special sample containers ADD-00069776B Abbott is the world leader in . Links which take you out of Abbott Laboratories worldwide web sites are not under the control of Abbott Laboratories, and Abbott Laboratories is not responsible for the contents of any such site or any further links from such site. After 48 hours, these specimens need to be recentrifuged between 30 000 75 000 g-minutes. For reagents stored off the system, it is recommended that they be stored in their original trays or boxes to ensure they remain upright.For information on unloading reagents, refer to the Alinity s SystemOperations Manual, Section 5.Indications of Reagent DeteriorationDeterioration of the reagents may be indicated when a calibration error occurs or a control value is out of the specified range.Associated test results are invalid, and samples must be retested.Assay recalibration may be necessary.For troubleshooting information, refer to the Alinity s System Operations Manual, Section 10. 3HCV is spread through contact with blood from an infected person, such as sharing needles to inject drugs. Printed copies are free of charge and will arrive in approximately 3 to 7 days. Specimens may be stored on or off the clot, red blood cells, or separator gel. We surveyed health systems and labs around the world to develop the Alinity m to meet your needs, now and into the future. 6-9. IR = Initially Reactive; RR = Repeatedly Reactive The specimens included the following: Anti-HIV-1/HIV-2 Positive (12), Anti-HTLV I/II Positive (11), HBV Positive (25), Anti-HAV Positive (15), Anti-HDV Positive (12), Anti-CMV (15), Co-infected CMV/EBV/ HSV (14), Anti-T pallidum Positive (15), Non-viral Hepatitis (15), Rheumatoid Factor Positive (15), Anti-ds DNA Positive (11), Pregnant Females (15), Multiparous Females (15), Hyper IgG/IgM (11), Influenza Vaccine Recipient (15), Hemodialysis Patients (15), HAMA Positive (15), E Coli Infection (13), Heterophilic Antibody Positive (14), Fungal (Yeast) Infection (15), ANA Positive (13), and Autoimmune Hepatitis (13). CLSI Document EP05-A3. Follow local chemical disposal regulations based on your location along with recommendations and content in the Safety Data Sheet to determine the safe disposal of this product.For the most current hazard information, see the product Safety Data Sheet.Safety Data Sheets are available at www.transfusion.abbott or contact your local representative.For a detailed discussion of safety precautions during system operation, refer to Alinity s System Operations Manual, Section 8. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. CI = Confidence Interval; RR = Repeatedly Reactive Preselected anti-HCV positive specimens were positive by anti-HCV assays and an FDA-licensed HCV RNA nucleic acid test. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Gower E, Estes C, Blach S, et al. For a description of the flags that may appear in this field, refer to Alinity s System Operations Manual, Section 5. You are about to leave for a 3rd party website. The Alinity s An ti-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.The Alinity s An ti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. A valid release control result is required to release test results. For troubleshooting information, refer to the Alinity s System Operations Manual, Section 10. Each specimen was tested at Day 0, and then subjected to either 2 to 8C storage for 14 days, room temperature (15 to 30C) storage for 3 days, 20C or colder storage for 12 months, or 6 freeze/thaw cycles. Search: Abbott Alinity User Manual. Alinity mp Instrument | Abbott Molecular. b One HBV positive specimen was repeatedly reactive using the Alinity s Anti-HCV II assay and negative by supplemental testing. Alinity 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. InterferencePotentially Interfering Endogenous SubstancesA study was performed testing potential interferents at or above the concentrations recommended in CLSI EP37. Testing of cadaveric serum and EDTA plasma specimens from patients with plasma dilution due to transfusions of > 2000 mL of blood or colloids within 48 hours, or > 2000 mL of crystalloids within 1 hour (or any combination thereof) prior to collection of the specimens has not been verified. Please select the specific Country and Language for Use website you intend to access. Abbott Molecular used the regulatory pathway in the development of its real-time monkeypox polymerase chain reaction test. A total of 3167 specimens from plasmapheresis donors were collected at one additional blood center. Abbott alinity qc abbott alinity user manual. abbott-architect-user-manual 1/5 Downloaded from odl.it.utsa.edu on November 7, 2022 by guest . For proper maintenance and usage, it's important to be able to have a maytag user manual handy. Preservative: sodium azide.ANCILLARY WASH BUFFER Pyrophosphate-buffered saline. Performance has not been established for cadaveric specimens that have undergone more than 6 freeze/thaw cycles. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Wayne, PA: CLSI; 2014. Viral Hepatitis. The Abbott Alinity hq analyzer demonstrated excellent reproducibility and between-batch precision for all CBC and WBC differential parameters. Madison, WI: Westgard Quality Corporation; 2010. 14 days If specimens are not processed directly after initial centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing. If an assay control value is not within range, sample results are not generated for in-process or scheduled samples. We and our partners use cookies to Store and/or access information on a device. The relative centrifugal force is generated during centrifugation. Globally, an estimated 58 million individuals are chronically infected. specimens with obvious microbial contamination. Other trademarks are the property of their respective owners. SPECIFICATIONS 2 This time period, referred to as the pre-seroconversion window period, often extends for several weeks after initial infection with HCV. Alinity s Anti-HCV II Reagent KitHepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide. Use a new applicator stick for each specimen to prevent cross ontamination. Quality Control ProceduresAssay ControlsThe Alinity s Anti-HCV II Assay Controls must be tested once every 24 hours when the system is being used.Assay control values must be within the ranges specified in the Alinity s Anti-HCV II Assay Control Kit package insert. From the couple eagerly awaiting the results of a pregnancy blood test to a worried cancer patient hoping for more answers . We use cookies to give you the best possible service. LEAB Automotive GmbH Thorshammer 6, SCT RC7-PD2 Camera Extension Kit for Poly Director II RC7-PD2 Application RC7-PD2 Installation Supporting the Poly EagleEye Director, VAPORESSO Luxe II 220W Starter Kit Thank you for choosing Vaporesso product. 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Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Bubbles may interfere with the detection of the reagent level in the cartridge and cause insufficient reagent aspiration that may adversely affect results. Basic QC Practices. Of the 314 specimens, 1 was repeatedly reactive using the Alinity s Anti-HCV II assay and was anti-HCV negative by supplemental testing.
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