Instruct patients to keep their patient information guide handy at all times. In 2019, approximately 290 000 people died from HCV-related liver disease, primarily due to cirrhosis and hepatocellular carcinoma (primary liver cancer). Both cartridges are required to perform the assay.Volumes (mL) listed in the table below indicate the volume per cartridge set. For a detailed description of how to run an assay, refer to Alinity s System Operations Manual, Section 5. Specifications may be assigned to non-validating controls. All 131 specimens were repeatedly reactive using the Alinity s Anti-HCV II assay and the commercially available anti-HCV assay. Abbott, Abbott Park, Ill, has announced that its Alinity m molecular diagnostics system and assays have received the CE mark. If the release control does not meet specifications, refer to the Alinity s System Operations Manual, Section 10, for additional information. Primary tubes may be on board the system for up to 10 hours. SpecificitySpecificity was determined by testing 55 cadaveric serum specimens, 55 cadaveric EDTA plasma specimens, 55 living donor serum specimens, and 55 living donor plasma specimens. The anti-HCV present in the sample binds to the HCV-coated microparticles and to the acridinium-labeled HCV conjugate. . Other trademarks are the property of their respective owners. Clear, nonhemolyzed specimens should be used when possible. False reactive results can be expected with any test kit. Abbott has product lines of branded generic pharmaceuticals, diagnostic systems and tests, pediatric and adult nutritional products (including well-known brands such as Similac and PediaSure), and medical devices for the treatment of cardiovascular diseases, including diabetes . SpecificityA total of 5277 fresh serum specimens and 7082 fresh plasma specimens from volunteer whole blood donors were collected at 3 distinct blood centers. rotor reaches the required RCF or rpm to the time it begins decelerating. VIEW NOW ADD TO LEARNING PLAN Alinity h-series Online Training The online product training provides users with basic step-by-step instructions on the use of the Alinity h-series hematology analyzer. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Repeatedly reactive specimens were further tested using an HCV qualitative RNA assay and an FDA-approved immunoassay for anti-HCV. Dispose of contents/container in accordance with local regulations. Printed copies of the user manuals may be requested from Customer Service. Other trademarks are the property of their respective owners. A non-reactive test result does not exclude infection. You can access your favorites from the Favorites tab at the top of the page. 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. abbott alinity user manual Abbott & Co - Medical Technology | Issue 15 | May 2019. Madison, WI: Westgard Quality Corporation; 2010. The website that you have requested also may not be optimized for your screen size. Abbott Announces Fda Clearance For Its Alinity Ci-Series Next www.hhmglobal.com. Perform any test, any time, including STAT samples, Consistent throughput regardless of assay mix. The relative centrifugal force is generated during centrifugation. Alinity s Anti-HCV II Reagent KitHepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide. 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. software may be downloaded and installed on i-STAT Alinity instruments either by a network connection to the Abbott Managed Server, or from the Abbott Point of Care website via a USB memory device. Abbott Manuals and User Guides All-Guides Database contains 120 Abbott Manuals (111 Devices) for Free Downloading (PDF). Performance has not been established for cadaveric specimens that have undergone more than 6 freeze/thaw cycles. If using primary or aliquot tubes, refer to the Alinity s System Operations Manual, Section 4 to ensure sufficient specimen is present. Abbott Alinity QC. Daily quality control results are outside of quality control limits used to monitor and control system performance. ACCELERATOR a3600 is a Class II laser product. 2011;100(1):9298. 5 In general 55%-85% of HCV infected individuals develop chronic infection, which is characterized by the continued detection of both HCV RNA and antibodies to HCV, persisting for decades after initial infection. Abbott Barcode Reader Manuals 1 Devices / 1 Documents Full list of Abbott Barcode Reader Manuals Abbott Blood Glucose Meter Manuals 27 Devices / 60 Documents Full list of Abbott Blood Glucose Meter Manuals The i-STAT Alinity is a hand-held, portable blood testing system, that allows a large menu of blood tests from a single device, from different types of blood chemistries to different types of . Abbott GmbHMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580DISTRIBUTED IN THE USA BYAbbott LaboratoriesAbbott Park, IL 60064 the USACustomer Service: Contact your local representative or findcountry-specific contact information at www.transfusion.abbottUS License No. After 48 hours, these specimens need to be recentrifuged between 30 000 75 000 g-minutes. 3HCV is spread through contact with blood from an infected person, such as sharing needles to inject drugs. J Hepatol. 2014;61(1 Suppl):S45-57. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. The calibrator must be priority loaded.Each assay control must be tested to evaluate the assay calibration.Once calibration is accepted and stored, it may be used for 14 days. Maximum number of replicates sampled from the same sample cup: 10. World Health Organization. By using our website, you agree to the use of cookies. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. Research driven dual target assay design. Hepatitis B, hepatitis C and HIV transfusion-transmitted infections in the 21st century. 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. In this case, reactive sample results must not be considered invalid.Quality Control GuidanceRefer to Basic QC Practices by James O Westgard, Ph.D. for guidance on laboratory quality control practices. the alinity m resp-4-plex assay is a multiplex real-time reverse transcription (rt) polymerase chain reaction (pcr) test intended for the simultaneous qualitative detection and differentiation of rna from sars-cov-2, influenza a virus (flu a), influenza b virus (flu b), and/or respiratory syncytial virus (rsv) in anterior nasal or nasopharyngeal To minimize the effects of evaporation, verify adequate sample cup volume is present prior to running the test. Total %CV values were determined. Release ControlsThe Alinity s Anti-HCV II Release Control must be tested in order to release test results.The release control is tested at user-defined intervals. 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. * Includes time on board the system.Reagents may be stored on or off the system. Genotype DetectionA total of 131 preselected HCV positive specimens of known genotype (genotypes 1-6) obtained from commercial vendors were tested using Alinity s Anti-HCV II assay. i This assay is for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.Sample, streptavidin-coated microparticles complexed with biotinylated HCV constructs, acridinium-labeled HCV conjugate, and assay diluent are combined to create a reaction mixture and incubated. The Abbott Alinity hq analyzer demonstrated excellent reproducibility and between-batch precision for all CBC and WBC differential parameters. The page provides a catalogue of brands and devices, each offering to view or download an updated manual Amplatzer Duct Occluders Service Manual Spectrum Datascope Spectrum Datascope 0070-01-0556-02_revD_srvc color 88 Octane Vs 87 The i-STAT Alinity system, designed to be easy, accurate and connected, integrates with-patient testing directly into . Global epidemiology and genotype distribution of the hepatitis C virus infection. Manage Settings 11 Pictures about Abbott & Co - Medical Technology | Issue 15 | May 2019 : Abbott receives FDA EUA for lab PCR assay that detects, differentiates SARS-COV-2, Flu A, Flu B, Abbott Alinity C - MYCO Instrumentation and also Instrumentation Instrumentation | American . McGraw-Hill; 2010:349 3 7 7. During this time, all subsequent samples may be tested without further calibration unless: This assay may require recalibration after maintenance to critical parts or subsystems or after service procedures have been performed. Basic QC Practices. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. 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. This Internet site that you have requested is intended for the residents of a particular country or countries and may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. If you want easier access to view often, click the heart icon next to each document below to add to your favorites. 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 . Printed copies are free of charge and will arrive in approximately 3 to 7 days. For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter. In general, antibodies to HCV are absent in the early weeks of infection and are not detected on average until 8-11 weeks after infection. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Having trouble finding a patient information guide, manual, or IFU? It is an automated platform, which can run more tests in less . Reduces complexity and streamlines workflow, Improve resource flexibility and ease of training, Drives maintenance and service cost optimization. All other specimens (including previously frozen plasmapheresis specimens) must be centrifuged between 30 000 75 000 g-minutes. 2 This time period, referred to as the pre-seroconversion window period, often extends for several weeks after initial infection with HCV. 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. Remove bubbles with an applicator stick before analysis. No interference was observed using the Alinity s Anti-HCV II assay.The effect of potentially interfering substances has only been evaluated for those listed in this package insert. 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. b One HBV positive specimen was repeatedly reactive using the Alinity s Anti-HCV II assay and negative by supplemental testing. A. Kit ContentsAlinity s Anti-HCV II Reagent Kit 04W56NOTE: This product is composed of 4 components, which are packaged as a 2-cartridge reagent set. 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. When the assay control values are within range, sample results are generated, and a valid release control result is required to release test results. Have an Abbott Molecular Laboratory representative contact you about our lab solutions. Abbott Molecular used the regulatory pathway in the development of its real-time monkeypox polymerase chain reaction test. EUA package insert instructions must be followed accordingly. When an invalidate control meets assigned specifications, sample processing continues, and a valid release control result is required to release test results. Please select the specific Country and Language for Use website you intend to access. As a result, the guide may make assumptions about th. Alinity m Resp-4-Plex AMP Kit Instruction Manual. You are about to enter a geographic specific site, The product specific Instruction for Use document is intended for the residents of a specific country or countries, as noted in the site selection. More on this. 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. If removed from the system, store reagents with new replacement caps in an upright position at 2 to 15C. Both the initial and repeat reactive rates for the serum specimens were 0.11% (6/5277), both the initial and repeat reactive rates for the plasma specimens were 0.11% (8/7082), and both the initial and repeat reactive rates for the plasmapheresis donor specimens were 0.19% (6/3167). 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. 22, alinity m pipette tips 50 ul, 9n2601, 60x96. Alinity ci-series Operations Manual.pdf - Free ebook download as PDF File (.pdf), Text File (.txt) or read book online for free. 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. Hepatitis C virus (HCV) is the causative agent of acute and chronic hepatitis infection. Seroconversion SensitivityThe seroconversion detection of Alinity s Anti-HCV II assay was compared to an FDA-licensed commercially available anti-HCV assay. Representative performance data are provided in this section. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. 56, alinity m service & support. Representatives are ready to offer support, gather feedback, and answer questions. The test, called the Alinity m MPXV test, uses lesion swab specimens from individuals suspected of . In 15 panels, the Alinity s Anti-HCV II and commercially available anti-HCV assays were reactive on the same bleed. The Alinity s Anti-HCV II assay is designed to detect antibodies to recombinant antigens representing Core and NS3 regions of the HCV genome. VIEW NOW If the user-assigned specifications for the non-validating control(s) are not met and the release control specifications are met, there will be no effect on sample processing. Data is not easily or effectively used to optimize performance. Minimum concentration: Peptide 50 ng/mL, antigens 200 ng/mL.ASSAY DILUENT Preservative: sodium azide. CLSI Document EP05-A3. 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. Preservative: sodium azide.CONJUGATE Acridinium-labeled HCV antigens (E coli, recombinant) and acridinium-labeled HCV Core synthetic peptide conjugate in pyrophosphate-buffered saline. Abbott Laboratories recognizes the importance of incorporating cybersecurity considerations early and throughout our product design and development process. For troubleshooting information, refer to the Alinity s System Operations Manual, Section 10. 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. Instructions must be carefully followed. The company's new technology will help keep up with the growing demand for infectious disease testing. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Some examples of search types are: XIENCE, MITRACLIP, stent, valve. Search: Abbott Alinity User Manual. Differences between genotypes are associated with responses to treatment. To prevent cross-contamination, the use of disposable pipettes or pipette tips is recommended. For a description of the flags that may appear in this field, refer to Alinity s System Operations Manual, Section 5. Pyrophosphate-buffered saline with surfactants. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. abbott-architect-user-manual 1/5 Downloaded from odl.it.utsa.edu on November 7, 2022 by guest . Anti-HCV II Reagent Kit en Anti-HCV II 04W56 H14970R01 B4W5G0 04W5660 Instructions must be carefully followed. If an invalidate control fails to meet assigned specifications, no sample results are calculated or provided by the system. 6th ed. Dienstag JL. WL2948775 Rev. Specimens should be free of bubbles. 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All-Guides Database contains 120 Abbott Manuals (111 Devices) for Free Downloading (PDF). 10. For optimal performance, it is important to perform routine maintenance as described in Alinity s System Operations Manual, Section 9. 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. Wayne, PA: CLSI; 2018. Contains Sodium Azide. Preservative: sodium azide.ANCILLARY WASH BUFFER Pyrophosphate-buffered saline. There were no changes to the interpretation; the data demonstrate that cadaveric serum and EDTA plasma specimens can be stored at the following conditions when tested using the Alinity s Anti-HCV II assay. Prior to centrifugation, previously frozen specimens (including previously frozen plasmapheresis specimens) must be mixed gently and thoroughly after thawing. 2020 Abbott Laboratories. 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. 2 Each HCV genotype can be presen in any given country, but there are geographical differences in prevalence. Falsely elevated results have been observed due to non-specific interactions (refer to the SPECIFIC PERFORMANCE CHARACTERISTICS section of this package insert). The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate Human Immunodeficiency Virus type 1 (HIV-1) RNA using plasma, serum and dried blood spot (DBS). Performance characteristics of this product have not been established for laboratory diagnosis of HCV infection. Core Laboratory at Abbott The Alinity h-series is part of a holistic family of personalized solutions from Abbott. CI = Confidence Interval; IR = Initially Reactive; RR = Repeatedly Reactive aBased on supplemental test results for the 20 repeatedly reactive specimens, 14 specimens were positive (3 blood donor serum, 6 blood donor plasma, and 5 plasmapheresis donor specimens), and 6 specimens were negative (3 blood donor serum, 2 blood donor plasma, and 1 plasmapheresis donor specimens); all 14 repeatedly reactive specimens found to be positive by supplemental testing were excluded from the specificity calculations.For total donors, the IR rate not reactive on retest was estimated to be 0.00% (0/15 506) with a 95% confidence interval of 0.00% to 0.08%.IR Rate Not Reactive on Retest = 100% (Number of IR Number of RR) / (Number Tested Number of RR). A total of 3167 specimens from plasmapheresis donors were collected at one additional blood center. Alinity h-series Operator's Manual The operator's manual provides approved procedures for operating the instrument correctly and efficiently. Contact with acids liberates very toxic gas. c Three of the 403 preselected anti-HCV positive specimens were from individuals diagnosed with acute infection based on the medical diagnosis and HCV RNA and/or anti-HCV results. Specifications may be assigned to invalidating controls. Receive exclusive access to resources with the Abbott Customer Portal (Diagnostics Portal). 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. FreeStyle, Libre, and related brand marks are marks of Abbott. Abaxis Global Diagnostics | Better at Point of Care | Abaxis In 10 panels, the 2 assays were reactive within 1 bleed. Alinity Mp Instrument | Abbott Molecular www.molecular.abbott. Biosafety in Microbiological and Biomedical Laboratories. For proper maintenance and usage, it's important to be able to have a maytag user manual handy. 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. It is the responsibility of the operator to verify that the correct specimen types are used with the assay. The "Yes" link below will take you out of the Abbott Laboratories family of websites. diagnostics alinity abbott. It is divided into at least 6 different genotypes (1-6) and several subtypes based on nucleotide sequence homology. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies. Four to six platforms are often needed for routine PCR testing, causing inefficiencies and requiring more staff training and broader knowledge. 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. We and our partners use cookies to Store and/or access information on a device. However, behind the scenes, the process of developing those . Each specimen was tested once using each of 3 lots of Alinity s Anti-HCV II Reagent Kit. Handheld and Abbott recommends that labeling be downloaded, printed, reviewed, and readily available for reference. Safety PrecautionsCAUTION: This product requires the handling of human specimens. If an assay control value is not within range, sample results are not generated for in-process or scheduled samples. We use cookies to give you the best possible service. Wiring diagram of charging system on craftsman riding mower 917.288250 Craftsman 917370610 user manual mower manuals and guides 1105177l Mtd . Every day, countless blood samples are tested to help diagnose and treat illness. Westgard JO. Alinity and related brand marks are trademarks of Abbott. Abbott Alinity User Manual ACCELERATOR a3600 is a Class II laser product FemoStop Gold Femoral Compression System We buy, sell, broker, and liquidate Chemistry, Hematology, Immunology, Coagulation, PCR, DNA and Analytical GCMS/LCMS analyzers and can save you up to 75% off new equipment costs! 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. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. Comparison with a Sysmex XN-9000 analyzer and manual 400-cell differential showed excellent .