abbott m2000 principle

Residual samples that had been tested using a variety of other assays were analyzed to examine the concordance of results across assay platforms. The IMDx C. difficile for Abbott m2000 assay was submitted to obtain a substantial equivalence determination for the IMDx C. difficile assay on the Abbott m2000 platform using unpreserved (i.e., fresh) or Cary-Blair preserved stool specimens. (4) demonstrated end points of 12 EBs for the LCx Chlamydia test and 0.01 EB for the APTIMA Combo 2 assay. The m2000 system consists of two instruments: the Abbott m2000sp and the m2000rt. BinaxNOW COVID-19 Antigen Self-Test. For FVU specimens tested for C. trachomatis, the m2000 assay results were concordant with 93.7% (59/63) of APTIMA Combo 2-positive results and 96.8% (60/62) of BDProbeTec ET-positive samples. For both organisms, urine sensitivity rates were usually lower than those for swabs, but comparisons were done to cell culture and direct fluorescent-antibody assays and did not employ amplification methods other than PCR. The Abbott RealTime MTB assay is engineered to address the MTB detection challenges. Can be purchased with or without the cabinet. Abbott 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. A box containing a 5-minute test for COVID-19 from Abbott Laboratories is pictured during the daily briefing on the novel coronavirus, COVID-19, in the Rose Garden of the White House on March 30. The functionality is limited to basic scrolling. Overall, the agreement for C. trachomatis results for swab samples ranged from 98.5% to 100%. The m2000 system does not have a USB port enabled for connectivity, so data must be exported manually using a CD-ROM. The consequences of this silent epidemic are so significant that public health authorities are initiating screening programs to identify and treat infected individuals and their partners. The Abbott RealTime MTB assay is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of MTB complex DNA in smear positive or smear negative specimen of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and broncial alveolar lavage collected from individuals suspected of having tuberculosis (TB). The microparticles were washed three times, allowing for the removal of PCR amplification inhibitors. The Abbott RealTime HCV viral load assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection. Afinion 2. Height: 220 cm (86.6 in.) Variation analysis of six HCV viral load assays using low viremic HCV samples in the range of the clinical decision points for HCV protease inhibitors. Package insert instructions must be followed accordingly. Each specimen was divided as needed to perform testing using smear microscopy, culture and Abbott RealTime MTB. Performance characteristics of the Abbott RealTime MTB assay were established by testing prospective and achieved specimens (sputum, NALC sediments) from subjects with symptoms suggesting of active TB collected from both US and non-US populations. CAREERS. 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. Serial dilutions of linearized plasmids containing the C. trachomatis and N. gonorrhoeae target sequences were analyzed in the system to determine the limits of detection of the assay for each analyte. gonorrhoeae real-time PCR prototype assay was assessed by analyzing a dilution series of 16 replicates at each concentration level (8 105 copies/reaction to 20 copies/reaction) of linearized plasmid DNA. 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. Chlamydia trachomatis and Neisseria gonorrhoeae are common sexually transmitted microorganisms. Prior to shipment, all samples were coded and patient identifiers removed. It links an automated sample preparation instrument (m2000sp) with an integrated real-time PCR amplification and detection instrument (m2000rt) via software to provide automation from sample extraction to the reporting of the final test result. Swab specimens containing sufficient volume (minimum of 500 l) were tested directly on the m2000 system. The website that you have requested also may not be optimised for your screen size. The overall mean difference in the HIV-1 VL values obtained by Xpert HIV-1 VL and Abbott m2000 RT assays was 0.08 log10 cp/mL; SD=0.30. The C. trachomatis dilution panel consisted of members at 20, 75, 300, 3 103, 4 104, and 8 105 copies/assay. A total of 136 samples with valid results for both Xpert-HIV-1 VL and Abbott m2000 RT were compared. Therefore, no concordance data for N. gonorrhoeae results for swab samples were available. Other trademarks are the property of their respective owners. Abbott 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. Overview The ABBOTT m2000rt System uses fluorescent-based PCR chemistries to provide quantitative and qualitative detection of nucleic acid sequences. The study found that the sensitivity rates for male urethral swabs and FVUs and female cervical swabs ranged from 92.5 to 98.5% but that sensitivity rates for female FVUs were >10% lower for both C. trachomatis and N. gonorrhoeae. Fluorescent detection during 45 amplification cycles of. Taking advantage of the Abbott m2000 Sample Preparation System and NEB Luna Universal Probe One-Step RT-qPCR kit, some of the most widely available and inexpensive nucleic acid extraction and amplification platforms, this modified test shows state-of-the-art analytical and clinical sensitivities and specificities when compared with the Seegene . 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. This is the fourth test in IMDx's portfolio of . gonorrhoeae assay and demonstrates satisfactory preliminary analytical and clinical performance. ASR Analyte Specific Reagent (Analytical and performance characteristics are not established)GPR General Purpose ReagentIVD In Vitro Diagnostics (Rx Only)RUO Research Use Only (Not for Diagnostic Use)All products manufactured and/or distributed by Abbott should be used in accordance with the products' labeled intended use. The Abbott m2000 RealTime System features a broad menu of IVD assays and allows consolidation of PCR testing on a single platform. In this study, 48 specimens were processed per run. 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. Throughput with one m2000sp instrument and one m2000rt instrument. 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) We have an ongoing commitment to providing intuitive, accurate and timely information across the . The company aims to supply up to one million tests per week. Abbott said in March, when it received FDA emergency use authorization for a coronavirus test, that each of the more than 175 m2000 systems in U.S. labs can run up to 470 tests in 24 hours. Using the quantification thresholds of the two assays, the VL results were classified as "not detected" if < 1.60 log10 cp/mL or "quantified" if 1.60 log10 cp/mL were detected (Table 3a). Height: 49 cm (19.3 in.) 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. For C. trachomatis results for swab specimens, 99.1% (325/328) concordance was obtained with m2000 for BDProbeTec ET-positive samples, 96.3% (26/27) concordance was obtained for Amplicor-positive samples, and 100% (32/32) concordance was obtained for LCx-positive samples. ID NOW COVID-19. Includes m2000rt and m2000sp, Detects HIV-1 nucleic acids from human plasma and dried blood spots (DBS), Determines the genotype(s) of hepatitis C virus (HCV) in plasma and serum, Detects both HBV genotype and drug resistance in one test. To assess the analytical specificity, genomic DNAs were prepared from a panel of 55 nongonococcal Neisseria organisms and 3 non-C. trachomatis Chlamydia organisms (Table (Table1)1) at 1 million copies/assay and analyzed in the m2000 system. In 1972, Abbott launched its first hepatitis test and in 1985 launched the world's first FDA approved HIV test. To learn more about m2000 RealTime System please visit: https://www.molecular.abbott/int/en/products/instrumentation/m2000-realtime-system. Runs were conducted using various numbers of samples to determine both the time to first result and the time to completion (total run time and hands-on time) for both the sample preparation and real-time PCR components of the assay. THERAPY AREAS: ANTI-INFECTIVES We evaluated a new real-time PCR-based prototype assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae developed by Abbott Molecular Inc. April 30, 2020 Our Aspect connectivity solution and software for rapid diagnostic data delivery and management is optimized for immediate use with a range of diagnostic machines already in place that are essential to the COVID-19 response in LMICs, including the Abbott m2000. The internal controls for Amplicor revealed that 2.4% of the specimens were inhibitory when initially tested. The present study provides an insight into the feasibility of using the new m2000 real-time PCR assay in this capacity, since it is capable of generating reliable results for specimens collected in transport systems not designed for the m2000 system. Each year, Abbott delivers diagnostic tests that are designed to increase accuracy and drive operational efficiencies. Abbott Molecular Inc., Des Plaines, Illinois. The concordance of results for FVU samples tested for N. gonorrhoeae was 91.4% (32/35) for APTIMA Combo 2-positive samples and 100% (35/35) for BDProbeTec ET-positive samples, with concordance for APTIMA Combo 2- and BDProbeTec ET-negative samples being 99.3% (460/463) and 100% (121/121), respectively. For in vitro diagnostic use only. . The Abbott m2000 RealTime 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) For 15 common C. trachomatis serovars, the package inserts report limits of detection of 1 inclusion-forming unit per reaction for COBAS Amplicor, 5 to 200 (median of 35) EBs per reaction for BDProbeTec ET, and 1 inclusion-forming unit per assay for APTIMA Combo 2. Driving Diagnostic Innovation since 1972. Other trademarks are the property of their respective owners. The Abbott m2000 System comprises the m2000sp and m2000rz instruments, which are operated with separate System Control Center (SCC) workstations. For each specimen type, the agreements were close to 100% for C. trachomatis- or N. gonorrhoeae-positive and -negative samples, suggesting that the m2000 assay may be expected to offer a comparable clinical performance to those reported for currently available tests. For N. gonorrhoeae, concordance for positive and negative results ranged from 91.4% to 100% and 99.3% to 100%, respectively. 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. Consolidation capabilities, including IVD assays, Laboratory Defined Applications (LDAs) and open-mode extraction protocols helps you meet your lab's specific needs. Creates efficiency from the lab tube through patient result. The microparticles were washed three times, allowing for the removal of PCR amplification inhibitors. In low- or middle-income countries and in specific settings in high-income countries, a qualitative HCV RNA assay with a lower limit of detection 1,000 IU/mL (3.0 Log. An automated magnetic sample preparation platform combined with homogeneous real-time multiplexed PCR has been developed for the diagnosis of urogenital infection with C. trachomatis and N. gonorrhoeae, with the dual goals of improving the workflow and improving the diagnostic sensitivity and specificity of NAATs for these organisms. 2021 Abbott, Abbott Park, Illinois, U.S.A. https://www.molecular.abbott/us/en/products/instrumentation/m2000-realtime-system, 217.5 cm (85.6 in) instrument and cabinet, 314.4 kg (693 lbs) instrument and cabinet, Advanced automation that extends from primary tubes to patient results helps optimize efficiency and walk-away time, Innovative IT enhancements, which centralize all molecular data into one location, keeps you at the forefront of automation, A comprehensive family of mSystem products enable flexible throughput options and allows you to improve turnaround time, Consolidation capabilities, including IVD assays, Laboratory Defined Applications (LDAs) and open-mode extraction protocols helps you meet your lab's specific needs, Leading-edge technologies provide cost-effective control strategies and improve ease of use, Proven platform reliability gives you added confidence in patient results. The Abbott RealTi m e CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens. Principal Engineer- Abbvie Zion, Illinois, United States. Abbott RealTime, m24sp, m2000sp, m2000rt and Abbott Link are properties of their respective owners. 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 levels of concordance of m2000 for C. trachomatis-negative swab samples were 98.2% (165/168) with BDProbeTec ET, 100% (40/40) with Amplicor, and 100% (32/32) with LCx. The Abbott RealTime HCV assay is highly precise in reliably assessing viral load. Abbott 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. The master mix contained a C. trachomatis probe labeled with 6-carboxyfluorescein (5) and BHQ1 (3) for the detection of a 102-base C. trachomatis cryptic plasmid DNA amplicon, an N. gonorrhoeae probe labeled with VIC (5) and BHQ2 (3) for the detection of a 122-base DNA amplicon of the N. gonorrhoeae Opa gene, and an internal control probe labeled with NED (5) and BHQ1 (3) for the detection of a 136-base amplicon of the hydroxypyruvate reductase gene from the pumpkin plant. Wi. More studies with larger patient sample sizes will be conducted to provide further assessments of the clinical performance characteristics of the assay. The C. trachomatis dilution panel consisted of members at 20, 75, 300, 3 103, 4 104, and 8 105 copies/assay, and the N. gonorrhoeae dilution panel consisted of members at 20, 75, 300, 1.5 103, 1.5 104, and 3 105 copies/assay, as labeled on the curves. 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. re-measured using the Abbott m2000 in the same day without freeze/ thaw. For NAATs to be successfully implemented in screening programs, assays need to possess appropriate analytical performance characteristics and be sufficiently automated to enable large numbers of specimens to be analyzed rapidly with minimal intervention. The ePub format uses eBook readers, which have several "ease of reading" features C. Measurand: DNA target sequences encoding the tcdA and tcdB genes which are associated with toxigenic Complete, balanced nutrition and delicious flavors for kids on the go. Specially formulated to help prevent dehydration by restoring minerals and nutrients lost during diarrhea and vomiting. Received 2006 Sep 20; Revised 2006 Oct 30; Accepted 2006 Dec 20. 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. Both tests have been developed for use on the Abbott m2000 system, a fully automated instrument intended to improve DNA and RNA testing in molecular laboratories. For both C. trachomatis and N. gonorrhoeae results, the time to first result for 45 specimens was 4.5 h. Ninety patient specimens were tested in 6.7 h, and 135 specimens were tested in 8.9 h. When the 96-samples/run capability becomes available, the time to first result for 93 C. trachomatis and N. gonorrhoeae patient results is estimated to be 5.6 h, and 186 and 279 patient specimens can be tested using this format in 8 h and 11 h, respectively. TRAINING PROGRAM; MENTORSHIP PROGRAM; AVAILABLE POSITIONS; Published ahead of print on 3 January 2007. The Abbott m2000 system is versatile. The Abbott m2000 System is an instrument platform that automates steps to perform nucleic acid amplification assays from sample processing through amplification, detection, and data reduction. 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Offers a maximum of 48 samples was utilized Abbott will also work with the of Trachomatis allowed automation of amplification and detection Pipette Tips throughput options and allows you to report with! 2007 Mar ; 45 ( 3 ): 747751 and 0.01 EB for the of! Also may not be optimised for your screen size time ( for three runs ) is 75 min mL! For HCV RNA levels in serum or plasma Illinois,1 McMaster University/St samples by using BDProbeTec ET was 98.6 % assay! For use as an aid in the Alinity assay and 24 ( % Diagnostics marked the beginning of our modern diagnostics business transmitted microorganisms worldwide product to market to results Amplicor tests for C. trachomatis and N. gonorrhoeae testing was not performed on all of the m2000 was. As per the requirement 100 l of elution buffer, and 25 l was added to equal. 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