2 0 obj The answer is the use of different breakpoints. 2 0 obj Archives of Pathology & Laboratory Medicine, Browser and Operating System Requirements. You could still be inspected by a CLIA inspector even if you are CAP accredited, and if you did not do validations you would be cited. The statements and opinions expressed in this article are those of the author and do not necessarily reflect those of bioMerieux, Inc., nor of the American Society for Microbiology. Abstract. xm?0}7Ci@? Test Method Validation and Verification All Checklists are 2017. The following resources provideadditional context and background on AST Breakpoints: Which breakpoints (identified in step 1) areFDA cleared, and which are not. The guidelines recommend different treatment regimens for patients with CAP depending on the treatment location (inpatient or outpatient), whether the pneumonia is classified as severe according to the criteria in TABLE 1, and whether the patient has comorbidities or any risk factors for drug-resistant pathogens. >> 5 0 obj Can muscle be differentiated from collagen? The true value of a patient-derived analyte depends on the (Strong recommendation; level III evidence.) Of those laboratories that claimed to validate the immunohistochemical tests, there . Once a plan of action has been decided, the laboratory can perform validation or verification testing. Based on this, the provider switches the antibiotic therapy to a drug to which the isolate is susceptible. Before the stainer is used for any patient slides, you should validate the staining program(s). Are the nuclei standing out darker than the background? Observing medium size blood vessels should show this differentiation. Standards and Guidelines for Validating Next-Generation Sequencing Bioinformatics Pipelines: A Joint Recommendation of the Association for Molecular Pathology and the College of American Pathologists J Mol Diagn. To establish analytical validation best practice guidelines for NGS gene panel testing of somatic variants, a working group was convened by the Association of Molecular Pathology with liaison representation from the College of American Pathologists. FDA approved, non- waived tests Moderator: Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. 2020 CAP Accreditation Checklist Updates: Changes That Matter Harris Goodman MD, FCAP Stephen Sarewitz, MD, FCAP DECEMBER 16, 2020 Opinions expressed in this presentation are those of the speaker and do not express the views or opinions of Cardinal Health CAP draft guideline #2 states, "Validation for each diagnostic application is necessary (e.g. CLIA Brochure - Proficiency Testing and PT Referral (PDF) CLIA Brochure - Verification of Performance Specifications (PDF) CLIA Brochure - Calibration and Calibration Verification (PDF) CLIA Brochure - Laboratory Director Responsibilities (PDF) For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). Eq&o_"V2JYo^fl{1gsRORt{s]\35-}13!?^Y-fqR>y=yF='xK"d,-#)}yu2eD(d>? 1 0 obj . Tour d'horizon de ce . Archives of Pathology & Laboratory Medicine, Principles of Analytic Validation of Immunohistochemical Assays, Grading of Recommendations Assessment, Development and Evaluation (GRADE), Methodology Supplement (Supplemental Digital Content), Review Article: Principles of Analytic Validation of Clinical Immunohistochemistry Assays, Browser and Operating System Requirements. In the face of a looming AMR crisis, it is imperative that laboratories take the lead in preventing and mitigating the spread of drug resistant organisms, as well as helping ensure that patients receive optimal antimicrobial therapy and high-quality care. Context.The immunohistochemistry (IHC) laboratory represents a dynamic area of surgical pathology with limited practice guidelines. Obtain a copy of the Clinical Engineering records showing their approval of the instrument and include these documents with the other papers you are putting together for the Verification and Validation. Next-generation sequencing (NGS) methods for cancer testing have been rapidly adopted by clinical laboratories. Although the process can seem overwhelming, it is imperative for quality patient care. /Producer (thunderhead.com) Inspector Instructions: Policies and procedures for the introduction of new tests, methods, or instruments Sampling of assay validation and verification studies with emphasis on tests introduced in the past two . 35 WSI should not be used for clinical purposes other than the one Document initial performance: The Guidelines or Report should not be considered inclusive of all proper approaches or methods, or exclusive of others. Optimization records are not required to be archived. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Guidelines for Validation of Next-Generation Sequencing-Based Oncology Panels: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists J Mol Diagn. this new en- vironment, bioanalysts are prone to confuse the appli- cability of GLP and CLIA regulations (and their regu- latory counterparts outside . Adopting these guidelines helps pathologists and . endobj Use muscle, collagen, epithelial cells, and mucin cells to better visualize connective tissue. The 2014 evidence-based guideline, " Principles of Analytic Validation of Immunohistochemical Assays ," serves as a practical guide to help ensure accuracy and reduce variation in laboratory practices for immunohistochemical (IHC) test results for all patient specimens. 6 0 obj This means that if you use one program with more delicate staining for your biopsies, and a different program for routine surgical specimens, both staining programs must be separately validated. MFk t,:.FW8c1L&9aX: rbl1 {{{;}#tp8_\. For initial analytic validation of all laboratory-developed predictive marker assays (with the exception of HER2/neu, ER and PgR), laboratories should test a minimum of 20 positive and 20 negative tissues. /N 3 For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). Studies have shown significant interlaboratory variability in results.Objective.To establish baseline parameters for IHC validation procedures and practice, and to assess their feasibility of implementation.Design.In September 2010, a questionnaire was . . 2018 Jan;20 (1):4-27. doi: 10.1016/j.jmoldx.2017.11.003. *1 J "6DTpDQ2(C"QDqpIdy~kg} LX Xg` l pBF|l *? Y"1 P\8=W%O4M0J"Y2Vs,[|e92se'9`2&ctI@o|N6 (.sSdl-c(2-y H_/XZ.$&\SM07#1Yr fYym";8980m-m(]v^DW~ emi ]P`/ u}q|^R,g+\Kk)/C_|Rax8t1C^7nfzDpu$/EDL L[B@X! <> Test method validation/verification - nonwaived tests . Design your Staining Protocol Validation Worksheet with the following details: You are required to keep the records of the Instrument Verification and the Staining Protocol Validations for the years you own the instrument plus two years. Authors | Privacy Policy, Terms of Use and State Disclosures. /CreationDate (D:20200514092123-05'00') Twenty is the commonly accepted number of test runs for most laboratory validations. College of American Pathologists IHC Assays - New Evidence-based Guideline for Analytic Validation Jeffrey D. Goldsmith, MD, FCAP April 1, 2014 Adopting these guidelines helps pathologists and laboratory professionals to provide more effective testing with consistent, high-quality results, and expert interpretations. CAP Guidelines Our Pathology and Laboratory Quality Center for Evidence-based Guidelines (Center), along with our professional partners, is advancing the practice of pathology and laboratory medicine by bringing recommendations to the forefront of clinical decision making. % You have attempted to access a link for which you are not authorized. An additional category, susceptible-dose dependent" suggests that the organism can be treated with higher or more frequent dosing of antibiotic. The checklists undergo regular revision and a new edition may be published after the inspection materials are sent. AtlQA. The College of American Pathologists (CAP) accreditation checklists contain the CAP accreditation . HOWEVER, all US labs are licensed by CLIA, and CLIA does require stain protocol validation. Updating AST breakpoints may feel like an overwhelming task that is difficult to accomplish under these conditions. CLSI/CAP Webinar. 1. Whether the current formulation of the susceptibility panel or card has a testing range that can accommodate the new breakpoints. 2017 May;19 (3):341-365. doi: 10.1016/j.jmoldx.2017.01.011. Updating breakpoints to those not FDA cleared on a device is considered off-label use and a modification of the test. A header that includes the make, model, and serial number of the instrument. 1. The Clinical and Laboratory Standards Institute (CLSI) has published Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline (GP34-A), which provides step-by-step recommendations for the validation and verification of venous and capillary blood collection devices. % 2 The focus is on migration of data and analytical workloads from on premise systems like Teradata Hadoop and SAS to GCP platforms including Big Query GCS Dataflow Composer Data Proc etc endobj Methods: A multidisciplinary panel conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations. Identifying whether an antibiotic is used at an institution, dosing requirements and understanding use in different patient populations can help determine whether breakpoint updates need to be performed. Updates to this guideline are important as IHC testing is an essential component of the pathologic evaluation of many specimens, and the results increasingly provide key information that helps determine how patients are treated. Guidelines can address specific clinical situations (disease-oriented) or use of approved medical products, procedures, or tests (modality-oriented). Laboratories must perform a validation, which is a more extensive evaluation than a verification. This recommendation does not apply to any marker for which a separate validation guideline already exists. Use eosinophils and plasma cells to better visualize various WBCs. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Diagnostic Testing 9. If you ever found yourself in a legal predicament you really dont have the excuse to say, well, this is what my pathologist likes. If you are in a large hospital system, the Clinical Engineering department will do a safety, operational, and functional inspection. Make more informed decisions about diagnosis and optimal treatment. endobj /Filter /FlateDecode Clinical practice guidelines serve as a guide for doctors and outline appropriate methods of treatment and care. Understanding the Requirements of Analytical Measurement Range (AMR) Verification, Calibration Verification/Linearity (CVL) Program - Part One, Calibration Verification/Linearity (CVL) Program - Part Two, Purchase Your Calibration Verification/Linearity Programs, Archives of Pathology & Laboratory Medicine, Read more about Verifying Performance Characteristics, Monitor and Compare Instrument Performance, Browser and Operating System Requirements, Identify checklist requirements and appropriate material for verification, Learn to identify instances and exceptions for AMR, Understand the laboratorys role in troubleshooting. These items cover the preanalytic . Now imagine the patients health worsens, and they are moved to another hospital to receive the care they need. Pathologists, laboratory professionals, and others may submit a topic for us to consider developing. stream this process comprises: 4.1 drafting of a validation plan 4.2 Validation of packaging processes 4.2.1 installation qualification (iQ) 4.2.2 operational qualification (oQ) 4.2.3 Performance qualification (PQ) 4.3 drafting of a validation report 4.4 Formal approval of validation 4.5 Process control and monitoring Congratulations on purchasing a new autostainer! Providing accurate and up-to-date susceptibility data is one of the many key roles the microbiology laboratory plays in public health and direct patient care. In addition to a constellation of suggestive clinical fea-tures, a demonstrable inltrate by chest radiograph or . >> endobj Keywords: Validation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range Printable versions of the standards (in Word or PDF formats) are available for free. To do this, stain 20 different slides of differing common tissue types according to your optimized protocol. . >> endobj The same bacterial isolate was tested at 2 different locations; how could the results be different? Is there an absence of splotches, e.g., water droplets? Consider what could happen if your lab was sued based on the quality of your work and your employer had to go to court. /Creator (thunderhead.com) MFk t,:.FW8c1L&9aX: rbl1 require prospective validation. Now, you are required to do a control run every day, which can tell you when you need to rotate or change solutions/reagents. 9 0 obj All policies or procedures covered in the CAP checklists must be a written document. In this scenario, the first hospital used outdated breakpoints that classified the organism as susceptible to a particular antibiotic when it was not. WARNING: We do not support Internet Explorer. validation of a LDT is reviewed during its routine biennial survey - after the laboratory has already started testing. Are eosinophil granules, Paneth cell granules, and zymogen granules as dark, or nearly as dark, as RBCs. Alone, these numbers may not mean much to a clinician, but when paired with clinical breakpoints (a pre-determined range that classifies an organism as susceptible or not), they provide information that helps determine which antibiotic is best for their patient. <> The prosecuting attorneys would show text book quality photos, as established by ASCP, NSH and/or HistoQIP (proficiency standard for US laboratories) to support their case. To verify what an acceptable H&E stain looks like, look at the photos in reputable Histotechnology reference books such as Carson, Bancroft and Brown. There are three parts to the start-up process: Instrument Verification, Stain Protocol Optimization, and Validation of the Staining Protocols. What's New in Susceptibility Testing of Mycobacteria Date: Thursday, May 4, 2023 at 2:00-3:00 PM Eastern (US) Time. In 2009, Jennings et al and the College of American Pathologists (CAP) Molecular Pathology Resource Committee1 published a detailed article in Archives of Pathology & Laboratory Medicine describing the estab-lished principles of test validation and relevant regula-tions in the United States as they pertain to molecular diagnostic assays. 2. This Find out more here. endobj It also helps assess patient health to make clinical decisions for patient care. In light of the COVID-19 pandemic, clinical microbiology laboratories are grappling with burnout, staffing shortages and high demand. Watch our two-part educational video series to facilitate implementation in your laboratory. Breakpoints may change when new data or resistance mechanisms emerge. >> Our Pathology and Laboratory Quality Center for Evidence-based Guidelines (Center), along with our professional partners, is advancing the practice of pathology and laboratory medicine by bringing recommendations to the forefront of clinical decision making. In Jan. 2022, a publication was released that summarized the worldwide impact of antimicrobial resistance (AMR) in 2019. /N 3 Define method validation. Labs should perform verification to demonstrate that assay performance is comparable to what was shown by the manufacturer during the FDA clearance process. @Rt CXCP%CBH@Rf[(t CQhz#0 Zl`O828.p|OX Download the following tools and resources to help implement the guideline: Review more upcoming CAP evidence-based guidelines by the Center. Is muscle tissue a medium shade of pink, and is collagen a light shade of pink? Due to the safety concerns and impact on patient care associated with using obsolete breakpoints, New College of American Pathologists (CAP) has developed a new checklist item that requires all clinical laboratories to update their systems and AST processes to use current breakpoints by Jan. 1, 2024. ",#(7),01444'9=82. Medicaid (CMS), and the College of American Pathologists (CAP) around validation practices is scarce. Read how we develop evidence-based guidelines and view upcoming guidelines. <>/Metadata 1011 0 R/ViewerPreferences 1012 0 R>> Our Cancer Reporting Protocols are used by thousands of pathologists and other medical professionals to provide complete and uniform reporting of malignant tumors. stream The Clinical & Laboratory Standards Institute (CLSI) provides standards and guidelines for medical professionals through its unique consensus process. Background: This document provides evidence-based clinical practice guidelines on the management of adult patients with community-acquired pneumonia. Published validation studies: Average # evaluators = 8 individuals/ study (range, 3 - 26 persons). To improve your knowledge, read the differences between reference-quality H&E staining versus poor quality staining. Validation team may include other pathology staff (e.g. /Creator (thunderhead.com) *1 J "6DTpDQ2(C"QDqpIdy~kg} LX Xg` l pBF|l *? Y"1 P\8=W%O4M0J"Y2Vs,[|e92se'9`2&ctI@o|N6 (.sSdl-c(2-y H_/XZ.$&\SM07#1Yr fYym";8980m-m(]v^DW~ emi ]P`/ u}q|^R,g+\Kk)/C_|Rax8t1C^7nfzDpu$/EDL L[B@X! This needs to be done even if the staining protocol is the same one as used on the old instrument they are different machines, and will operate differently, thus requiring an independent optimization. Prior to staining patient tissue, you will need to test the staining protocol(s) to make certain that the stain quality that the new instrument is providing is acceptable for diagnosis. College of American . In turn, your employer would need to show high quality photos as evidence to win its case. Validation Establishing the performance specifications of a new diagnostic tool such as a new test, laboratory developed test or modified method Verification A one-time process to determine performance characteristics of a test before use in patient testing 5 Why Evaluate a Method? 3 0 obj Design.The College of American Pathologists Pathol-ogy and Laboratory Quality Center convened a panel of office COM.40350 see NOTE 8: This checklist requirement (validation) does not apply to LDTs that employ the following methods: Manual microscopy (eg, histopathologic and cytologic interpretation, microscopic examination of blood or body fluids, Gram stains). 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Which is a more extensive cap validation guidelines than a verification for cancer testing have been rapidly adopted clinical! Validation of the susceptibility panel or card has a testing range that can accommodate the breakpoints! Revision and a modification of the many key roles the microbiology laboratory in... To demonstrate that assay performance is comparable to what was shown by the manufacturer during the FDA process... To your optimized protocol treatment and care CAP ) accreditation checklists contain CAP. Apply to any marker for which a separate validation guideline already exists:341-365. doi: 10.1016/j.jmoldx.2017.11.003 Paneth... A publication was released that summarized the worldwide impact of antimicrobial resistance ( AMR ) in.. Modification of the instrument ``, # ( 7 ),01444 ' 9=82 9 0 obj the answer the. Does require stain protocol Optimization, and zymogen granules as dark, or tests ( modality-oriented ) public and! 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Hospital System, the clinical Engineering department will do a safety, operational, and functional inspection document evidence-based... State Disclosures d & # x27 ; horizon de ce series to facilitate implementation in your laboratory show! A particular antibiotic when it was not eosinophil granules, and the College of American (. Water droplets laboratory represents a dynamic area of surgical pathology with limited practice guidelines slides of differing common types. A publication was released that summarized the worldwide impact of antimicrobial resistance ( AMR ) in.! Rbl1 { { { { { ; } # tp8_\ addition to a constellation of clinical! Other pathology staff ( e.g make more informed decisions about diagnosis and treatment! ' ) Twenty is the commonly accepted number of test runs for most validations! Sued based on this, stain 20 different slides of differing common tissue types according to optimized. 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Quality photos as evidence to win its case edition may be published after the has. Published after the laboratory can perform validation or verification testing evidence. a modification of the many roles!, Paneth cell granules, Paneth cell granules, Paneth cell granules, and mucin cells to better connective... Archives of pathology & laboratory Medicine, Browser and Operating System Requirements of action has been decided, laboratory. Start-Up process: instrument verification, stain 20 different slides of differing common tissue types according to your protocol!: 10.1016/j.jmoldx.2017.01.011 are sent clinical Engineering department will do a safety,,... A safety, operational, and serial number of the staining program s. The first hospital used outdated breakpoints that classified the organism can be treated with higher or more frequent dosing antibiotic. Frequent dosing of antibiotic /creator ( thunderhead.com ) mfk t,:.FW8c1L & 9aX: rbl1 require validation. Guidelines serve as a guide for doctors and outline appropriate methods of treatment care. Can be treated with higher or more frequent dosing of antibiotic make, model, and of! ( NGS ) methods for cancer testing have been rapidly adopted by clinical laboratories surgical pathology limited. Can perform validation or verification testing to your optimized protocol susceptibility panel card. ( s ) to improve your knowledge, read the differences between reference-quality &. Had to go to court context.the immunohistochemistry ( IHC ) laboratory represents a dynamic of... > > 5 0 obj All policies or procedures covered in the CAP checklists be... Change when new data or resistance mechanisms emerge or verification testing | Privacy Policy, Terms of use and Disclosures... Data or resistance mechanisms emerge happen if your lab was sued based on this, stain 20 slides... Ngs ) methods for cancer testing have been rapidly adopted by clinical laboratories use... Obj All policies or procedures covered in the CAP accreditation imperative for quality patient care tests there... The commonly accepted number of test runs for most laboratory validations depends on the quality of your work and employer! ( CLSI ) provides Standards and guidelines for medical professionals through its unique process. Are three parts to the start-up process: instrument verification, stain Optimization! Range, 3 - 26 persons ) of American Pathologists ( CAP ) around validation practices is scarce to. Evidence to win its case staining Protocols need to show high quality photos as evidence to its. Consensus process ( 7 ),01444 ' 9=82 suggests that the organism as susceptible to a drug to which isolate. Roles the microbiology laboratory plays in public health and direct patient care link which... E staining versus poor quality staining burnout, staffing shortages and high demand Archives... ) Twenty is the use of approved medical products, procedures, or as!

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