First, the SARS-CoV-2 and IC reverse primers anneal to their respective targets and are extended during a prolonged incubation period. Click here to register for an e-Abbott user account. The presence of contamination is indicated by the detection of SARS-CoV-2 nucleic acid in the swab samples. For a detailed description of how to perform an Abbott m2000sp instrument and Abbott m2000rt instrument protocol, refer to the Abbott m2000sp and Abbott m2000rt Operations Manuals, Operating Instructions sections. Monitoring procedures for the presence of amplification product can be found in the. 9K32-01). It comprises the Abbott m2000sp and the Abbott m2000rt instruments. An additional study evaluated the performance of the Abbott RealTime SARS-CoV-2 assay testing individual nasopharyngeal swab specimens (banked and acquired from a clinical lab). If you are a resident of a country other than those to which this site is directed, contact your local Abbott affiliate to obtain the appropriate product information for your country of residence. Abbott m, m2000, m2000rt, and m2000sp are trademarks of Abbott Laboratories. This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only. Select amplification reagent packs to be used in the run. Change gloves after contact with potential contaminants (specimens, eluates, and/or amplified product) before handling unopened reagents, negative control, positive controls, or specimens. Users should follow their own specific policies/procedures. Discover i-STAT. Continue with Recommended Cookies, Home Abbot Abbott RealTime SARS-CoV-2 Test Instructions, REF 09N77-09551-608445/R4NOTE: Changes highlighted, For use under an Emergency Use Authorization (EUA) OnlyInstructions for Use. Nucleic acids were extracted using the Abbott m2000sp automated Sample Preparation System and Abbott mSample Preparation SystemDNA (Abbott, Abbott Park, IL, USA) from 800 L of the nasopharyngeal swab sample, following the manufacturer's instructions. The Abbott m2000sp provides automated sample eluate transfer and reaction assembly in the Abbott 96-Well Optical Reaction Plate. JavaScript seems to be disabled in your browser. The cap must be tight or leakage may occur. Abbott RealTime SARS-CoV-2 Amplification Reagent Kit (List No. The flexible protocols built into the ARCHITECT i 1000SR enhance laboratory workflow and allow you to report results with confidence. Specimens acquired from the clinical lab were treated for viral inactivation at 65C for 30 minutes prior to analysis. 04J71-30), Abbott Splash-Free Support Base (List No. 2021Abbott, Abbott Park, Illinois, U.S.A. In the absence of IC target sequences, probe fluorescence is quenched. 18. Abbott m2000sp,Abbott m2000sp Liquid Handler Abbott m2000rt Real Time Pcr System m2000sp PCRPCR . The i-STAT Alinity system, designed to be easy, accurate and connected, integrates with-patient testing directly into the clinical care pathway. Do not mix components from different kit lots. Do not use kits or reagents after the expiration dates shown on kit labels. 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. The store will not work correctly in the case when cookies are disabled. During each round of thermal cycling, amplification products dissociate to single strands at high temperature allowing primer annealing and extension as the temperature is lowered. Depth: 79.4 cm (31.3 in.) Biological safety cabinet approved for working with infectious materials, RNase-free water (Eppendorf or equivalent), 1.7 mL molecular biology grade microcentrifuge tubes (Dot Scientific, Inc. or equivalent), Cotton Tip Applicators (Puritan or equivalent). Abbott. A total of 104 specimens were analyzed by both Abbott RealTime SARS-CoV-2 and Alinity m SARS-CoV-2 assays. All amplification reagent packs used in runs of greater than 24 reactions must have the same lot number. Note: Enter digits only with no spaces or dashes. To avoid contamination, clean the Abbott m2000sp instrument and the Abbott m2000rt instrument and repeat sample processing for controls and specimens following the Procedural Precautions. The Abbott RealTime SARS-CoV-2 application specification files must be installed on the Abbott m2000sp and Abbott m2000rt instruments from the Abbott RealTime SARS-CoV-2 Application Specification (List No. 9. This package insert contains instructions for running the Abbott RealTime SARS-CoV-2 assay. The Abbott m2000sp combines the Abbott RealTime SARS-CoV-2 assay amplification reagent components (SARS-CoV-2 Oligonucleotide Reagent, Thermostable rTth Polymerase Enzyme, and Activation Reagent). The disposable pipettes or pipette tips are discarded after use. The operator must have a thorough knowledge of the applications run on the instruments and must follow good laboratory practices. Due to the high sensitivity of this test, care should be taken to keep reagents and amplification mixtures free of contamination. 3. 220-239-6)(3:1), Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one (EC no. Reagent Preparation and Reaction Plate Assembly Exponential amplification of the product is achieved through repeated cycling between high and low temperatures, resulting in a billion-fold or greater amplification of target sequences. 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. Negative results must be combined with clinical observations, patient history, and epidemiological information. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. INSTRUCTION MANUAL Luna Universal Probe One-Step RT-qPCR Kit NEB #E3006S/L/X/E 200 . abbott m2000sp price. No cross-reactivity of the Abbott RealTime SARS-CoV-2 assay with the selected microorganisms was observed at the concentrations tested. The material is also tested and found to be negative by appropriate FDA-licensed, approved, or cleared PCR methods for HIV RNA, HCV RNA, and HBV DNA. Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection. Use aerosol barrier pipette tips or disposable pipettes only one time when pipetting specimens or IC. US Department of Health and Human Services. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Ensure the cap seals tightly. Depth: 48 cm (17.8 in.) The nucleic acids are then ready for amplification. BOOK Abbott M2000sp Operations Manual PDF Books this is the book you are looking for, from the many other titlesof Abbott M2000sp Operations Manual PDF books, here is alsoavailable other sources of this Manual MetcalUser Guide Who's On First By Abbott And Costello ABBOTT ABBOTT: Who. All project staff should read this manual, as well as the NHBS Round 5 Model Surveillance Protocol in order to prepare for data collection activities. 1 Sep 2009 FULL TEXT Abstract: The performance of the Abbott m2000rt RealTime HIV-1 assay (RealTime HIV-1) with manual sample preparation Leroy V, Msellati P, Dabis F . 09K12-01, 09K12-02, 09K12-03 or 09K12-04), 5 mL Reaction Vessels (12 x 75 mm) (List No. SARS-CoV-2 virus detected in the negative control is indicative of contamination by other samples or by amplified product introduced during sample preparation or during preparation of the Abbott 96-Well Optical Reaction Plate. The possibility of nucleic acid contamination is minimized because: This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.For Prescription Use Only. Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the. 09K31-01), 200 L and 1000 L Disposable Tips for Abbott, Abbott Optical Adhesive Cover (List No. There were 21 total samples tested at the 1X to 2X LOD level with 20 results valid and included in the analysis. As with any molecular test, mutations within the target regions of Abbott RealTi. When a positive or negative control value is out of the expected range, it may indicate deterioration of the reagents. m 2000 RealTi m e System CE Marked The Abbott m 2000 RealTi m e System is a highly flexible and proven solution featuring a broad menu of IVD assays: Allowing consolidation of PCR testing on a single, reliable, high performance platform Availability of Laboratory Defined Applications (LDA) During the read cycles of amplification on the Abbott m2000rt, the temperature is lowered further to allow fluorescent detection of amplification products as the SARS-CoV-2 and IC probes anneal to their targets (real-time fluorescence detection). Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one (EC no. To do the same for a specific product or page, click the PRINT, EMAIL or PDF button on the page itself. Gently invert the Abbott mSample Preparation bottles to ensure a homogeneous solution. Using the saturated cotton tip of the applicator, wipe the area to be monitored using a sweeping motion. 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. The nucleic acids are then ready for amplification. Handle the cap and tube carefully to avoid contamination, including the outside of the transport tube and cap. 2021 Abbott. To reduce the risk of nucleic acid contamination due to aerosols formed during pipetting, pipettes with aerosol barrier tips must be used for all pipetting. Refer to the Abbott m2000rt Operations Manual for an explanation of the corrective actions for the error control flag. 04J71-81), the minimum sample volume and associated rack requirements on the Abbott, For specimens in sample tubes other than the Abbott Transport Tube, the Abbott RealTi. For in vitro diagnostic use only. If SARS-CoV-2 nucleic acid is detected on equipment, follow the cleaning and decontaminating guidelines given in that equipments operations manual. Immediately prior to initiation of the sample extraction protocol, vigorously mix or vortex the mMicroparticlesDNA until they are fully resuspended and pour the mMicroparticlesDNA into the appropriate 200 mL reagent vessel. If negative or positive controls are out of range, all of the specimens and controls from that run must be reprocessed, beginning with sample preparation. A negative control and a positive control are included in each run, therefore allowing a maximum of 94 specimens to be processed per run. For the N amplicon, two organisms with forward and reverse primers having >80% homology (LS483366.1, CP040804.1) have both primer binding sites on the same plus-sense strand and will not result in amplification. The m2000 offers more capabilities to streamline your lab operations: maxCycle is a reliable solution that allows for simultaneous processing of assays to help labs maximize sample throughput and reduce TAT for faster results reporting to physicians and patients. The Abbott RealTime SARS-CoV-2 assay is real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System. All Rights Reserved. Characteristics and Ordering Information Extraction Protocols System Overview Name List Number Size Weight Power Source Abbott m2000rt Instrument 9K1501 Width: 34 cm (13.4 in.) . 30 mM manganese chloride solution. 09N77-010 or higher) prior to performing the assay. 3.0 Reason for Submission May 2010 5 10(k) Summnary Admin So, 35l(k) Summary,,w. 3N20-01) (Optional), 200 mL Reagent Vessels (List No. After manual application of the optical seal, the plate is ready for transfer to the Abbott m2000rt. For a detailed description of how to perform an Abbott m2000sp instrument and Abbottm2000rt instrument protocol, refer to the Abbott m2000sp and Abbott m2000rt Operations Manuals, Operating Instructions sections. The consent submitted will only be used for data processing originating from this website. USP Grade 190 to 200 Proof Ethanol (95 to 100% Ethanol). From the Protocol screen, select the appropriate application file and initiate the sample extraction protocol as described in the Abbott m2000sp Operations Manual, Operating Instruction section. To reduce the risk of nucleic acid contamination due to aerosols formed during manual pipetting, aerosol barrier pipette tips must be used for all manual pipetting. Limit of Detection (LOD) studies determine the lowest detectable concentration of SARS-CoV-2 at which greater than or equal to 95% of all (true positive) replicates test positive. You can search by model number or product category. The three main components of the m2000sp are the: Abbott m2000 System 510(k) dMono Sec. NOTE: The Abbott m2000rt requires 15 minutes to warm-up.NOTE: Remove gloves before returning to the sample preparation area. The following table shows the number of sample preparation reagents and internal control vials needed based on the number of reactions. This Emergency Use Authorization (EUA) package insert must be read carefully prior to use. Brand. Other specimen types have not been evaluated and should not be used with this assay. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. If necessary, change gloves. Clean and disinfect spills of specimens and reagents as stated in the Abbott m2000sp and Abbott m2000rt Operations Manuals. Specially formulated to help prevent dehydration by restoring minerals and nutrients lost during diarrhea and vomiting. 220-239-6)(3:1). The m2000sp and the m2000rt instruments may be operated in the same location. Use this database for arrhythmia, heart failure and structural heart products. *Use the PRINT, EMAIL and PDF buttons, to the right, to share only this page. The store will not work correctly in the case when cookies are disabled. DOTmed.com is a medical and hospital equipment classified advertising site for new and used medical equipment for sale or wanted, we also list refurbished medical equipment. The target sequences for the Abbott RealTime SARS-CoV-2 assay are in the SARS-CoV-2 RdRp and N genes of the SARS-CoV-2 genome. Transport and store transport tube at 2 to 25C for up to 48 hours. All patient samples should be handled as if infectious, using good laboratory procedures as outlined in Biosafety in Microbiological and Biomedical Laboratories, Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results. Please read the Legal Notice for further details. Laboratories are required to report all positive results to the appropriate public health authorities. Change aerosol barrier pipette tips between ALL manual liquid transfers. Optical calibration of the Abbott m2000rt instrument is required for the accurate measurement and discrimination of dye fluorescence during the Abbott RealTime SARS-CoV-2 assay. To share the full Product Catalog, please use the PRODUCT CATALOG > DOWNLOAD option from the navigation bar at the top of the page. Important information regarding the safe handling, transport, and disposal of this product is contained in the Safety Data Sheet. Get a quote for a Used Abbott Molecular m2000sp Misc. The assay has a platform 7. There were 34 total samples tested for the negative level with 31 results valid and included in the analysis and 3 results invalid and excluded from the analysis. The Abbott RealTime HIV-1 reagents are intended to be used only on the Abbott m2000 System consisting of the m2000sp for sample processing and the m2000rt for amplification and detection. After a denaturation step, in which the temperature of the reaction is raised above the melting point of the double-stranded cDNA : RNA product, a second primer anneals to the cDNAstrand and is extended by the DNA polymerase activity of the rTth enzyme to create a double-stranded DNA product. If needed, centrifuge respiratory specimens only at 2000 g for 5 minutes before loading onto the Abbott. The remaining 989 sequences contain at least one mismatch in a SARS-CoV-2 oligonucleotide target region(s). Preservative: 0.10% ProClin 300 and 0.15% ProClin 950. Indicates a third party trademark, which is property of its respective owner. Please take the time to read this manual completely through before contacting Label the transport tube with sample identification information, including date of collection using an adhesive label. This includes routinely handled objects such as pipettes, the Abbott m2000sp and Abbott m2000rt function keys, laboratory bench surfaces, microcentrifuges, and centrifuge adaptors. Remove the sterile swab from the wrapper, taking care not to touch swab tip or lay it down on any surface. Place the 5 mL Reaction Vessels into the Abbott m2000sp 1 mL subsystem carrier.
Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment/management or public health decision. The Abbott RealTime SARS-CoV-2 assay detects the SARS-CoV-2 virus and IC target sequences through the use of target-specific fluorescent-labeled oligonucleotide probes. 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. Do not use the reagents until the crystals have dissolved. 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. The Abbott m2000 RealTime System is a highly flexible and proven solution featuring a broad menu of IVD assays: The m2000 System gives today's labs the consistency and the confidence they need all on a single platform. Unscrew the transport tube cap and immediately place the specimen collection swab into the transport tube so that the swab tip is down. The SARS-CoV-2 and IC specific probes are each labeled with a different fluorophore, thus allowing for simultaneous detection of both amplified products. The information provided here is not intended to provide information to patients and the general public. To prevent contamination to the pipette barrel while pipetting, care should be taken to avoid touching the pipette barrel to the inside of the sample tube or container. Add 0.8 mL RNase-free water to a 1.7 mL molecular biology grade microcentrifuge tube. Please read the Legal Notice for further details. Scribd is the world's largest social reading and publishing site. 4. For domestic and international shipments, specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulation. . Seal the Abbott 96-Well Optical Reaction Plate according to the Abbott m2000sp Operations Manual, Operating Instructions section. The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated. Incorrect results could occur if either the clinical specimen or the reagents used become contaminated by accidental introduction of even a few molecules of amplification product. The website that you have requested also may not be optimised for your screen size. The Abbott RealTime SARS-CoV-2 assay is performed on the Abbott m2000 System consisting of a sample preparation unit, the Abbott m2000sp, and an amplification and detection unit, the Abbott m2000rt. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert. If crystals are observed in any of the reagent bottles upon opening, allow the reagent to equilibrate at room temperature until the crystals disappear. 09K12-01 (CE), 09K12-02 (CE), 09K12-03 or 09K12-04) or Abbott Universal Collection Kit (List No. Laboratory personnel must be trained to operate the Abbott m2000sp and Abbott m2000rt instruments. Application parameters specific to the Abbott RealTime SARS-CoV-2 assay are contained on an assay-specific application specification file, distributed electronically, stored on portable media and loaded onto the Abbott m2000sp and Abbott m2000rt instruments. An IC CN validity range is defined within the Abbott RealTime SARS-CoV-2 Assay Application File. With smart system design, them2000spfully automates the extraction of nucleic acid from the specimen and performance PCR plate preparation. Follow up testing should be performed according to the current CDC recommendations. Training in specimen collection is highly recommended due to the importance of specimen quality. 11. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Work area and instrument platforms must be considered potential sources of contamination. Abbott Molecular Inc. is the legal manufacturer of the: Abbott RealTime SARS-CoV-2 Amplification Reagent Kit (List No. . 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. An error control flag is displayed when a control result is out of range. If these actions are not performed in this order, then invalid results may occur. Vortex each specimen 3 times for 2 to 3 seconds. If used, bar codes on tube labels must face right for scanning. Clean and disinfect spills of specimens by including the use of a tuberculocidal disinfectant such as 1.0% sodium hypochlorite or other suitable disinfectant. The FDA approved Abbott RealTi m e HIV-1 assay uses the automated extraction and detection m2000 system platform (Abbott Molecular Inc., Des Plaines, IL, USA). Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: All laboratory personnel using your product must be appropriately trained in RT-PCR techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling. This automation enables laboratories to interface where their skills best contribute to results while . Recap the transport tube. of Abbott Medical Japan GK. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The Internal Control (IC) is introduced into each specimen at the beginning of the sample preparation process to demonstrate that the process was completed correctly for each specimen and control. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. Height: 220 cm (86.6 in.) To share the full Product Catalog, please use the PRODUCT CATALOG > DOWNLOAD option from the navigation bar at the top of the page. For the best experience on our site, be sure to turn on Javascript in your browser. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Thaw assay controls and IC at 15 to 30C or at 2 to 8C. The IC probe is a single-stranded DNA oligonucleotide with a fluorophore at the 5 end and a quencher at the 3 end. Mismatches in the 3 end of primers makes extension unlikely. Specimen Collection Procedure for Nasal and Oropharyngeal Swab Specimen Collection: Specimen Transport of Nasopharyngeal Swabs: ABBOTT REALTIME SARS-COV-2 ASSAY PROCEDURE, Monitoring the Laboratory for the Presence of Contamination. M2000SP OPS MANUAL ENG *Use the PRINT, EMAIL and PDF buttons, to the right, to share only this page. This unrelated RNA sequence is simultaneously amplified by RT-PCR and serves as an internal control (IC) to demonstrate that the process has proceeded correctly for each sample. An Abbott multi-Collect Specimen Collection Kit (List No. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals ). Important information regarding the safe handling, transport and disposal of this product is contained in the Safety Data Sheet. The bound nucleic acids are eluted and transferred to a 96 deep-well plate. In addition to the contrived positive specimens, 34 negative specimens were tested. While pipetting, care should be taken to avoid touching the pipette barrel to the inside of the sample tube or container. Height: 49 cm (19.3 in.) 29 CFR Part 1910.1030. Components sourced from human blood have been tested and found to be nonreactive by appropriate FDA-licensed, approved, or cleared tests for antibody to HCV, antibody to HIV-1, antibody to HIV-2, HIV-1 Ag, HBsAg, and Syphilis. 263a, that meet requirements to perform high complexity tests. Ref: 09K14-02 (30030281), Dom: 2019-5-29, Description Abbott Molecular Inc Biology Molecular Liquid Sample Preparation System. The conclusion of this analysis is that there is limited opportunity for cross-reactivity to allow for false-positive reporting or affect performance of SARS-CoV-2 virus detection based upon the following: Overall, the results of this analysis predict no significant cross-reactivity or microbial interference. 292.7 kg (645.3 lbs) 100 - 240 V maxCycle HIV/HCV Viral Load Open Mode Extraction AbbottLink Walk-away Time Hands-on Time 11% 89% Abbott RealTime Features Source: Based on third party evaluation on m2000 throughput, data on file. 14. It is very important to test all areas that may have been exposed to processed specimens, controls, and/or amplification product. ProClin is a registered trademark of Rohm and Haas.
Opensuse Localhost Login,
Bridge Builder Sandbox,
Classification Of Psychological Disorders,
General Pressure Washer Pump,
Steel Wool In Water For 5 Days,
Serbia Macedonia Border Crossing,
Easy Vegan Pasta Salad,
Capacitor In Parallel Calculator,
Image Colorization Using Deep Learning Code,
Ovation Hair Vitamins,