Thanks to extensive clinical validation on nsclc through concordance with pdl1 ihc 22c3 pharmdx for autostainer link 48, laboratories can implement pdl1 testing on dako omnis with complete diagnostic confidence. Autostainer link 48 ensures optimal staining results and o. Manufacturer specifications autostainer 48 link, dako. Page 1 leica autostainer xl automated slide stainer instructions for use leica autostainerxl, v2. Dako autostainer plus slide stainer rankin used histology. Colley and stead white paper on autostainer link 48 software. Dako pt link pretreatment module the dako pt link pretreatment module is an easytouse pretreatment system that optimizes staining consistency.
Followingincubation with the primary monoclonal antibody to pd l1 or the negative control reagent ncr, specimens are incubated with a linker antibody specific to the host species of the primary antibody. Pdf optimized immunohistochemistry workflow facilitated by new. Readytouse antibodies and advanced connectivity options complete a solution that helps you ensure patients quickly. Reduced down time by experienced technicians who fully understand the design and function of the autostainer. The autostainer xl achieves its high throughput by means of an innovative. Refer to pdl1 ihc 288 pharmdx interpretation manual nonsquamous nonsmall. Autostainer link 48 dako and a benchmark ultra ventana medical systems, tucson, az according to the manufacturers instructions. Canadian multicenter project on standardization of programmed. None of the equipment posted for sale on is owned by medwow, should you have any questions regarding a specific item, please direct them to the appropriate seller by making use of. Following the alpha study, a phase ii beta test of new software developed specifically to enhance efficiency was evaluated. Epitope, staining platform, clone name, clone format, version date, view.
Leica st5010 autostainer xl automated slide stainer. Reliability and innovation come together in autostainer link 48. Autostainer, ups 110v only, report printer, 2x label printers, computer pkg, pt module a80500024 110v a80500023 240v autostainer 480s product description items included specifications part number autostainer 480s autostainer 480s, ups 110v only, report printer, 2x label printers, computer pkg max. None of the equipment posted for sale on is owned by medwow, should you have any questions regarding a specific item, please direct them to the appropriate seller by making use of the available communication channels on the items page. Link 48 and innovative dakolink software constitute a proven workhorse in the ihc staining laboratory. Dako pt link pretreatment module rankin histology lab. Laboratories without this stainer may optionally develop highly accurate 22c3 ihc laboratorydeveloped test ldt on other. The autostainer xl is the result of an extensive research program to provide an innovative stainer which meets the quality requirements of the modern laboratory, as well as. Overview of automated immunohistochemistry archives of. Lab vision autostainer 480s2d thermo fisher scientific. An overall 76% of the samples that were difficult to score were in the 1%.
Epitope staining platform clone name clone format version date view. Central coast pathology donated a dako autostainer to the biomedical engineering department that can perform immunohistological stains of up to 48 samples simultaneously using tightly controlled reagent volumes and incubation times. Plus, combine it with the cv5030 glass coverslipper to create a workstation that eliminates the manual handling of slide racks between staining and coverslipping. Pt link and autostainer link 48 contribute to reliable, high quality results slide after slide. The dako pdl1 22c3 pharmdx kit is a qualitative assay intended for use in the detection of pdl1 in formalinfixed, paraffinembedded ffpe in non. The autostainer link 48 is dakos newest addition to the dako link solution for immunohistochemistry.
The dako autostainer plus is a co mbination of har dware and software integrated with the appropriate reagents to automate immunohisto chemical and imm unocytoche mical staining methods. However, dako recommends to discontinue the use of herceptest in the slide position 34, 35 and 36, depending on make and model of the. Save space and centralize slide programming by connecting up to three instruments and three pt links to one computer the dakolink software has optimized runtime estimation. Dako currently supplies one such instrument, the autostainer link 48. High agreement of pdl1 scores was found between pdl1 ihc 22c3 pharmdx on the autostainer link 48 and the dako omnis platform, whether applied to histologic or cytologic cell blocks, with an overall agreement of 99% and positive agreement and negative agreement of 95%.
Optimal fixation for total preanalytic phase evaluation in. Manage all your slides with one solution stay ahead of the changing needs in ihc. Semantic scholar extracted view of optimized immunohistochemistry workflow facilitated by new dako autostainer link 48 software by elizabeth c. Autostainer link 48 ensures optimal staining results and offers a high slide and reagent capacity. Therefore, for laboratories using the ptlink, an additional brief 15 minute. Manufacturer specifications autostainer 48 link, dako please note. Aug 10, 2017 the pdl1 ihc 22c3 pharmdx assay requires autostainer link 48 instrument. Autostainers are renowned for their consistency and reliability and are the most widely used ihc platfor. Used dako autostainer link 48 slide stainer for sale dotmed. Agilent hp autostainer link 48 user guide pdf medwrench. The clone used in the autostainer was mib1 in dako autostainer link 48, and it was 309 in benchmark ultra. Patients rely on ihc and ish slides for definitive answers. Dako autostainer, dako pt link 48 autostainer, and biocare. With quality, efficiency and total tissue care, bond helps you complete more slides, with highdefinition staining and minimal tissue loss.
Leica autostainer xl instructions for use manual pdf download. Staining quality was excellen t for both antier a clone ep1 and antipr clone pgr 1294 on the dako omnis. While some laboratories still employ manual methods to. Faster response time since the autostainer is the only instrument we service.
The contractors service representative csr shall contact the coracor to schedule an inspection or prior to responding to a service call. Pdl1 ihc clone 22c3, pharmdx is an fda approved companion diagnostic for pembrolizumab performed on a dako autostainer link 48. View and download leica autostainer xl instructions for use manual online. Leica vt100s vibratome the leica vt s vibrating blade microtome is. Pdf use of the 22c3 antipdl1 antibody to determine pdl1. Deparaffinization, rehydration, and target retrieval was performed in the pt link dako pt100 using a 3in1 procedure.
Ihc staining procedure was performed using the dako autostainer link 48 platform and an automated staining protocol validated for the pdl1 ihc 22c3 pharmdx assay. Dako autostainer plus slide stainer the dako autostainer plus slide stainer s3800 is an automated horizontal slideprocessing system compatible with openmarket reagents for immunostaining formalinfixed, paraffinembedded tissues, frozen sections, cytospins, cell smears, and fineneedle aspirates. The performance of the assay for pdl1 status determination based on 1% and 5% thresholds was established for daytoday, sitetosite, observertoobserver reproducibility on the dako autostainer link 48 by conducting a blinded study in 3 external clinical laboratory improvement amendments certified clinical labs where the laboratory. Dako autostainer solution brochure us version agilent. As100 autostainer plus link instrument 35 and 36 as480 autostainer link 48 instrument system 34 s3400 autostainer 35 and 36 s3800 autostainer plus 35 and 36 you may continue to use your instrument s. Rabbitmousegoat link 10 x 11 ml streptavidin peroxidase 10 x 11 ml substrate chromogens product code no. Artisan link provides walk away automation for special stains, controlling all procedural requirements and includes the following hardware.
Statement of work preventive maintenance for pathology lab. Leica autostainer xl instructions for use manual pdf. The dako autostainer is a proven and validated system. Autostainer link dakos fourth generation autostainer solution based on nearly 50 years of experience developing leadingedge technology for the pathology lab. The dako autostainer link 48 system at the university of. Comparison of pdl1 expression using 2 validated pdl1 ihc 2. Meet the immunohistochemistry needs of most laboratories with the thermo scientific autostainer 480s2d, a standard, compact platform that provides flexible options to meet varied workflow needs. Quick startup dakos autostainer support team installs and tests the system to ensure proper operation. The food and drug administrationapproved pdl1 ihc 22c3 pharmdx cdx assay dakoagilent was used as a reference standard ihc assay and as a comparator assay for the assessment of diagnostic accuracy. Csr shall acknowledge receipt of a service call within 2 hours and shall arrive on the premises to effect repairs within 24 hours. Pdf immunohistochemical performance of estrogen and. Leica st5010 autostainer xl the proven autostainer xl continues to provide reproducible, consistent, highquality staining and increased workload throughput.
Up to 48 slides can be individually programmed and processed in a given run. Includes flex readytouse reagents, dakolink software, pt link and autostainer link 48. Setup autostainer link 48 pt link setup autostainer plus impressively high autostainer link 48 speed and capacity new autostainer link 48, full 48 slides load dakos previously fastest autostainer, full 48 slides load new autostainer link 48, 30 slides load common 30slide instrument 60% more slides are processed in one run on the new. Patented reaction chamber slide carousel with a 48 slide capacity reagent carousel with up to 50 reagents the artisan link software monitors and runs the staining instruments from the workstation pc. Clinical utility of the combined positive score for. Autostainer xl laboratory equipment pdf manual download. Leica bond polymer refine 1 100% ventana benchmark ultra.
This study compared the results from pdl1 expression level analysis across four immunohistochemistry platforms dako autostainer link 48, dako omnis, leica bondiii, and ventana benchmark ultra. Asts carries a complete inventory of parts to fix the majority of autostainer problems upon the first visit. The testing was performed according to the assays instruction manual on the autostainer link 48 dako agilent. Optimal fixation for total preanalytic phase evaluation in pathology. Pdf optimized immunohistochemistry workflow facilitated by. Jun 26, 2018 this study compared the results from pdl1 expression level analysis across four immunohistochemistry platforms dako autostainer link 48, dako omnis, leica bondiii, and ventana benchmark ultra. The pdl1 ihc 22c3 pharmdx assay requires autostainer link 48 instrument. Scoring methods the cps is given by summing the number of pdl1stained cells tumor cells, lymphocytes, macrophages and dividing the.
1254 1409 13 78 847 239 1309 323 225 1520 492 282 305 1236 525 1211 66 410 1268 664 786 1354 1434 1320 746 955 905 75 178 1143 1300 577 726 494 705 1181 328 829 1374 354 1111 342 1047 178 386 170 754 582 573 211