Quick Guide To Quality Assurance Of Xpert MTB/RIF Testing
Quick Guide toQuality Assuranceof Xpert MTB/RIFTesting
Quick Guide toQuality Assuranceof Xpert MTB/RIFTesting
ContentsAcknowledgementsiiiAcronyms and AbbreviationsivAbout this quick guidevTarget audiencevBackground1Standards and key activities for assuring quality1From standards and procedures to implementation1Key quality assurance activities3Element 1. Governance3Element 2. Strategic planning4Element 3. Quality procedures and documentation5Element 4. Training, competency assessment and certification6Element 5. Data connectivity and remote monitoring7Element 6. A safe and functional testing site8Element 7. Equipment and supplies9Element 8. External quality assessment (EQA)10Element 9. Monitor performance of Xpert MTB/RIF testing and the QA/QC system11Element 10. Strengthen the clinical-laboratory interface and the diagnostic cascade12Additional resources13Notes14iiQuick Guide to Quality Assurance of Xpert MTB/RIF Testing
AcknowledgementsThis guide is substantially based on a pre-publication version which was developed and piloted bythe Foundation for Innovative New Diagnostics (FIND) and the U.S. Centers for Disease Control andPrevention (CDC), with funding from the United States President’s Emergency Plan for AIDS Relief(PEPFAR) under Cooperative Agreement 3U2GPS002746. The following people contributed to thedevelopment and review of the original version:Lead writers: André Trollip and Heidi Albert (FIND, Cape Town, South Africa). Reviewers: HeatherAlexander, Kyle DeGruy, Patricia Hall, Peter Minchella, Bill Coggin (CDC), Daniela Cirillo, Elisa Tagliani(San Raffaele Scientific Institute, Milan, Italy), Martina Casenghi (Médecins Sans Frontières-AccessCampaign, Geneva, Switzerland), Kekeletso Kao, Jesse Wambugu (FIND, Geneva, Switzerland).Revision and finalization of the guide: led by Thomas Shinnick (independent consultant), Heidi Albert(FIND, South Africa) and Josephine San Pedro (CDC) with technical contributions from Andre Trollip(FIND, South Africa), Kyle de Gruy and Patricia Hall (CDC). Critical review was provided by membersof the Global Laboratory Initiative (GLI) Core Group, including Lice Gonzalez Angulo, Maka Akhalaia,Kathleen England, Marguerite Massinga Loembe, Alaine Umubyeyi Nyaruhirira and Abiola Tubi. Copyediting: Beatrice Gordis (FIND, Switzerland)The mention of specific companies or of certain manufacturers’ products does not imply that they arerecommended in preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken to verify the information contained in this publication.However, the published material is being distributed without warranty of any kind, either expressedor implied. The responsibility for the interpretation and use of the material lies with the reader. In noevent shall there be liability for damages arising from its use. The findings and conclusions in this reportare those of the authors and do not necessarily represent the official position of the Centers for DiseaseControl and Prevention/ The Agency for Toxic Substances and Disease Registry.The revision and finalization of the guide was made possible through funding from the AfricanSociety for Laboratory Medicine (ASLM) as part of a project supported by the United States President’sEmergency Plan for AIDS Relief (PEPFAR) under Grant No.NU2GGH000710.iiiQuick Guide to Quality Assurance of Xpert MTB/RIF Testing
Acronyms and AbbreviationsCDCU.S. Centers for Disease Control and PreventionCQIContinuous quality improvementEQAExternal Quality Assurance / AssessmentGLIGlobal Laboratory InitiativeM&EMonitoring and evaluationMDR-TBMultidrug-resistant tuberculosisNTPNational TB ProgrammeNTRLNational TB Reference LaboratoryPPEPersonal protective equipmentPTProficiency testingQAQuality assuranceQCQuality controlRIFRifampicinSOPStandard operating procedureTBTuberculosisTOTTraining of TrainersWHOWorld Health OrganizationivQuick Guide to Quality Assurance of Xpert MTB/RIF Testing
About this guideThis quick guide provides an overview of the processes and tools to establish and implement a qualityassurance (QA) system for the Xpert MTB/RIF test across the diagnostic network and summarizes thedetailed practical guidance found in the Practical Guide to Implementing a Quality Assurance System for XpertMTB/RIF Testing1.The QA system is designed to ensure the following are in place and sustained: All testing is done in compliance with national testing algorithms and SOPs; A cadre of competent users are available to perform the test; Testing sites provide uninterrupted diagnostic and testing services unaffected by stock-outs andmodule failures; Samples of optimum quality and quantity are collected Xpert MTB/RIF test results are reported in a timely manner to avoid delay in treatment; Technical assistance, guidance and on-site supportive supervision and training are provided to testingsites, particularly where needed; The TB diagnostic network is monitored, using electronic systems where possible, and the datacollected are analysed, evaluated and used for decision-making.The strategies and approaches described in this document are not unique to the Xpert MTB/RIF test.This guide can therefore be used to inform development of a quality improvement approach for othertests using the GeneXpert platform, as well as other molecular near point-of-care and point-of-careinstrument-based diagnostic tests or platforms.Target audienceThis guide is intended for implementers of the Xpert MTB/RIF test and quality assurance managersacross the laboratory diagnostic network. Specifically, this guide is intended to inform Ministry ofHealth officials, National TB Programme officials, National TB Reference Laboratory personnel, donors,implementing partners, quality assurance unit personnel, programme managers, testing site managers,supervisory staff and GeneXpert users at national, regional or testing site level on how to implementactivities to assure the quality of Xpert MTB/RIF results.Note: In this guide, the term ‘testing sites’ is used to denote a site where the Xpert MTB/RIF test is beingperformed and includes both traditional laboratories and point-of-care or other clinical testing siteswhere the Xpert MTB/RIF test is being performed. Furthermore, to ensure the quality of the overalldiagnostic process, some of the QA processes (e.g., use of SOPs, participation in supervisory visits,monitoring performance indicators, training, etc.) target activities at participating clinical sites (e.g.,specimen collection sites, sample referral centers, and clinics).Note: In this guide, the term Xpert MTB/RIF test is used to denote either the Xpert MTB/RIF test or theXpert MTB/RIF Ultra test. When the two tests differ (e.g., whether or not a ‘trace’ result is generated), thetests will be described separately.1 Available at: k Guide to Quality Assurance of Xpert MTB/RIF Testing
BackgroundFailure to provide a quality Xpert MTB/RIF result can result in either under- or over-diagnosis ofTB. Under-diagnosis can lead to worsening of disease and can contribute to the spread of TB (anddrug-resistant TB) in the community (Bailey, 2011)2. Over-diagnosis may result in unnecessary patienttreatment and stigma. Failure to get accurate results can undermine confidence in laboratory testingleading to under-utilization of services and over-reliance on clinical diagnosis.A laboratory test is just one part of the diagnostic process, which starts with the patient experiencingsymptoms and seeking care (passive case finding), or a health care worker identifying a person to beevaluated for TB (active case finding), then continues to a test being ordered by the health care worker,referral of the specimen to the laboratory for testing, receipt of the test results by the health care worker,initiation of appropriate treatment, and finally to monitoring of response to therapy. Lack of qualityor delays in any of these steps can reduce the clinical and public health impact of laboratory testing.As such, a system to ensure the quality of laboratory testing must address all the relevant parts of thediagnostic cascade, not just what happens in the laboratory.Standards and key activities for assuring qualityQuality standards are requirements that must be fulfilled to assure quality Xpert MTB/RIF testing.Standards that were developed to measure the performance of the TB diagnostic network form the basisof the benchmarks used for the Xpert MTB/RIF QA system. They are based on standards developed bythe Global Laboratory Initiative (GLI) for ensuring the quality of AFB smear microscopy3, by the AfricanSociety of Laboratory Medicine and Association of Public Health Laboratories for evaluating diagnosticnetworks4, and by USAID and partners for evaluating TB diagnostic networks in Nigeria and India5.The QA activities associated with each standard are shown in Table 1 and are discussed in subsequentsections in this document. Note that the number of each QA element (e.g., Element 1) correspondsto a subsequent section in this quick guide as well as to the corresponding section in the full QAImplementation Guide.From standards and procedures to implementationThis quick guide provides an overview of the practical steps to be taken at the national level and at thetesting sites for the implementation of a system for ensuring the quality of Xpert MTB/RIF testing at alllevels of the TB diagnostic network. At the national and supervisory levels, the QA activities focus on theprocesses and systems needed to ensure quality testing in all facilities and includes developing nationalpolicies and procedures; monitoring and evaluating performance indicators; conducting ExternalQuality Assurance (EQA) and Proficiency testing (PT) programs; and providing supportive supervision.At the individual testing site, the QA system focuses on the processes and procedures to ensure the qualityand reliability of each test performed in the laboratory and a well-functioning laboratory-clinical interfaceto ensure efficient referral for testing, prompt reporting and linkage to care of diagnosed patients.The key steps required to accomplish each of the individual QA elements shown in Table 1 are brieflydescribed in the subsequent sections. More details and specific practical guidance on accomplishing theactivities are available in the full Xpert QA Guide.2 Bailey S.L. et al. 2011. Missed opportunities for tuberculosis diagnosis. Int J Tuberc Lung Dis 15: 205-103 TB Microscopy Network Accreditation. An assessment tool. Global Laboratory Initiative. 2013. croscopy Network Accreditation Web.pdf4 Ondoa, P. et al. A new matrix for scoring the functionality of national laboratory networks in Africa: introducing the LABNET scorecard. AfricanJournal of Laboratory Medicine, 5, Oct. 2016. iew/498/7125 Albert, H. Essential standards for a TB diagnostic network. ASLM20161Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Table 1: Diagnostic Network Standards and Key QA ActivitiesDiagnostic Network StandardsKey QA ActivitiesStructures & policies are in place that enablecontinuous, country-wide availability of free, qualityassured diagnosis according to the national guidelines.Governance (Element 1): Establish a governancestructure with clearly defined roles, responsibilities &linkagesPlanning (Element 2): Conduct a situational analysis,strategic planning, and develop a prioritized, budgetedaction plan for phased implementation of the QAactivitiesA minimum package of tests & quality standards isdefined for each level of the TB diagnostic network.QA documentation (Element 3): Develop &disseminate the SOPs, bench aids, forms, documents& records that will be needed to ensure the quality oftestingAdequate numbers of competent, well-trained &motivated technical & managerial staff are available atall levels of the diagnostic network.Training & certification (Element 4): Develop &implement a training, competency assessment &certification program to ensure the availability ofqualified laboratory staffInter-operable & inter-connected electronic recording& reporting systems are in place that generate reliabledata that are monitored & analysed in real time.Data connectivity & remote monitoring (Element5): Utilize remote monitoring systems to collect &analyse data relating to performance indicators, QA andprocurementTesting is performed in a manner & in facilitiesthat ensure safety for the staff, the customers, thecommunity & the environment.A safe and functional testing site (Element 6): Create &maintain safe & functional testing sitesTesting is performed with state-of-the-art and wellmaintained equipment and an uninterrupted supply ofquality reagents & consumables.Equipment & supplies (Element 7): Ensure wellfunctioning equipment & a reliable supply of reagentsContinuous quality improvement (CQI) targets allfacilities within the network and includes qualityindicator monitoring, external quality assurance ®ular on-site supervision.Proficiency testing (PT) & supportive supervision(Element 8): Develop and implement an externalquality assessment (EQA) program that includesquality indicator monitoring, PT, on-site supportivesupervision and timely feedback and corrective actionsMonitoring & evaluation (Element 9): Monitor &evaluate the performance of Xpert MTB/RIF testing &of the QA/CQI systemAn efficient diagnostic-clinical interface allows forappropriate diagnostic tests to be ordered & performed& ensures the timely linkage of diagnosed patients toappropriate care &treatment.Strengthen the clinical-laboratory interface & thediagnostic cascade (Element 10): Strengthen theclinical-laboratory interface to ensure that nationaltesting algorithms are followed, the correct test isordered, quality samples are collected, accurate resultsare reported, results are correctly interpreted & patientsare placed on appropriate therapy2Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Key Quality Assurance ActivitiesElement 1. GovernanceIt is important to note that while these guidelines focus on Xpert MTB/RIF QA and CQI programs,governance structures may already exist for other programs such as HIV, TB, QA and biosafety oflaboratory services. Xpert MTB/RIF QA and CQI activities should be incorporated wherever possibleinto existing governance structures with clear lines of communication and reporting.The governance structure at the national and supervisory level will likely vary by country. In manycountries, implementation of national policies and procedures are coordinated at the central level bythe Ministry of Health, national TB programme (NTP) or national TB reference laboratory (NTRL). Insome settings, particularly in large countries, these activities may be decentralized to the regional level.Commonly, the central level provides policies, guidance and tools for standardized QA activities, whilethe regional and district levels operationalize and supervise the QA activities and monitor the adherenceto the procedures. In turn, data collected at the testing sites are reviewed regionally and centrally andused to inform and update policies and procedures, thereby closing the CQI cycle.Activities at a glanceNational, Regional, and District LevelTesting site levelEstablish a governance structureEstablish a governance structureEstablish a National QA Office orCoordination Team with a NationalLaboratory QA OfficerAppoint, train and empower a QA officerEstablish lines of communication acrossthe diagnostic network3Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 2. Strategic planningThe strategic planning process is typically conducted at the national level with input from other levelsand should include 1) a situational analysis to determine the current status of Xpert MTB/RIF QAactivities, 2) design of a QA system customized to the country’s situation, 3) development of a costedprioritized action plan for phased implementation of the required QA activities with targets and a timeline, and 4) allocation of an adequate budget and resources for the implementation and annual operationof QA activities.The situational analysis informs the implementation of QA activities at central, regional, testing site andparticipating clinical site level. Some QA components may have already been implemented to varyingdegrees. The phased implementation plan and time line should focus on providing the appropriatestructures (e.g., quality teams, data monitoring units), support (e.g., training, supportive supervision,constructive feedback) and monitoring and evaluation processes (e.g., collection and regular analysisof key performance data) needed to implement a functioning QA process. For example, implementinga proficiency testing (PT) program without implementing a corresponding system of timely feedback,corrective actions and supervisory visits will greatly limit the usefulness and impact of the PT programon the quality of testing.Depending on available human resources and funding, countries may decide to prioritizeimplementation of certain activities that could rapidly produce improvements in the quality of testingwith a limited investment. That is, certain activities (e.g., monitoring and evaluating quality indicators)require limited resources to implement and maintain, beyond initial development of data collectiontools and training of staff.Countries may focus on implementing all QA components and monitoring all indicators at a selectednumber of sites initially, and once successfully implemented, a scale up plan will be developed forall sites. Alternatively, countries may work on establishing a selection of QA activities at all sites, thenexpanding the range of QA activities once the initial implementation has been completed. Eitherway, an important focus should be on the quality of the entire diagnostic cascade including clinical,programmatic and laboratory services. Monitoring the progress of implementation will help identifychallenges that could affect the outcome. Addressing these challenges will greatly improve the chances ofsuccessful rollout of the QA activities.Activities at a glanceNational, Regional, and District LevelTesting site levelAssemble the teamParticipate in a situational analysisDefine roles and responsibilitiesAssist with the development of anaction planConduct situational analysisAssist with the development of aQA budgetDevelop a strategic plan to implementand sustain the QA systemSet the budget and time line4Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 3. Quality procedures and documentationWithout accurate and complete documentation, the quality of Xpert MTB/RIF test results may becompromised. The documentation must address activities throughout the diagnostic cascade includingdocumentation for clinical and programmatic activities (e.g., specimen collection and referral, reporting)as well as laboratory activities. Standardized documents, records and forms should be developed at the national level and distributedto all testing and participating clinical sites to assure conformity. Standardizing documents, records and forms will take time. Therefore, plan the implementation ofstandardized documentation in a systematic manner. SOPs, forms, documents and records must be up-to-date, accurate, and readily accessible at all testingand participating clinical sites. A document control system is needed to ensure regular review of quality documents (e.g., SOPs) andthe correctness of the documentation that supports laboratory testing.Activities at a glanceNational, Regional, and District LevelTesting site levelGenerate QA documentsReceive documents from supervisory ornational levelDisseminate QA documentsCustomize documents by adding testingsite specific informationImplement document control systemImplement a document control systemEnsure users read and understand the QAdocuments5Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 4. Training, competency assessment and certificationTraining, competency assessment and certification are critical components of providing quality assuredXpert MTB/RIF test results. The implementation of the Xpert MTB/RIF test in a quality assured mannerrequires training beyond the steps required to carry out the test. Manufacturer-supplied on-site trainingfollowing installation is often too short to cover QA activities. The testing site manager must ensure thatGeneXpert users are trained in the operation of the GeneXpert instrument, correct performance of theXpert MTB/RIF test and carrying out the associated QA activities.Competency assessments should be performed after training and periodically (e.g., annually).Assessment of skills of staff performing on-site supervision, training and mentoring should be included,as well as competency assessment for performing the test. Templates for conducting and recording theresults of a competency assessment can be found in the Xpert QA Guide.Activities at a glanceNational, Regional, and District LevelTesting site levelCustomize training packageConduct trainingTrain users in the operation of theGeneXpert instrument, Xpert MTB/RIFtest and QA activitiesPerform competency assessmentsAssess users for competency6Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 5. Data connectivity and remote monitoringDiagnostics connectivity refers to the ability to connect diagnostic test devices that produce results ina digital format, such as GeneXpert instruments, in such a way as to transmit data reliably to a varietyof users. Key features of the systems are the ability to remotely monitor performance, conduct QAand manage inventory. With remote monitoring, designated persons can use any internet-enabledcomputer to access the software platform, providing them with an overview of the facilities, devices andcommodities in their network. Software can track consumption and inventory to avoid stock-outs andexpiring cartridges, as well as identify commodity lots or specific instruments with poor performanceor abnormal error rates for QA purposes. This can provide a highly cost-effective way to ensure properfunctioning of a diagnostic device network.Data can also be transmitted automatically to 1) clinicians and patients which allows for faster patientfollow-up, 2) laboratory information management systems or electronic registers, reducing staff timeand the chance of transcription errors, and greatly facilitating monitoring and evaluation processes,and 3) the NTP to assist with surveillance of disease trends or resistance patterns, as well as enhance thecapacity of the NTP to generate the data needed for several of the performance indicators of the End TBStrategy.Detailed information on the design and implementation of a diagnostics connectivity solution may befound in the GLI Quick Guide to TB Diagnostics Connectivity Solutions.6Activities at a glanceNational, Regional, and District LevelTesting site levelSelect a data connectivity solutionWork with national level to determinewhich diagnostic connectivity system willbe usedConnect all GeneXpert instrumentsObtain and install all needed hardwareand equipmentPrepare SOPs and train usersIdentify and train usersImplement SOPsEstablish lines of communication6 GLI Quick Guide to TB Diagnostics Connectivity Solutions. 2016. http://www.stoptb.org/wg/gli/gat.asp.7Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 6. A safe and functional testing siteIn a functional testing site, the GeneXpert instrument will be properly positioned in a clean, securelocation and placed on a vibration free bench (not directly under an air conditioning unit). In addition,there should be an uninterrupted supply of power and appropriate working and storage conditions(humidity and temperature controlled). In a safe environment, WHO biosafety recommendations forconducting the Xpert MTB/RIF test will be followed with adequate ventilation, appropriate personalprotective equipment (PPE) will be used, and biologic waste will be disposed of safely and in accordancewith regulations. Failure to provide a safe and functional work environment can impact the quality oftesting in several ways, including: An unsafe testing site is a hazard to staff, patients and the environment In an unsecure testing site, test results may be delayed if there is equipment failure or theft Testing sites that do not maintain uninterrupted power, optimal working temperature, and a cleanenvironment can have equipment failures and high error rates that delay reporting and waste reagentsThe selection of which sites will conduct Xpert MTB/RIF testing is usually determined by the NTP orNTRL and is based on factors such as TB epidemiology, geographic considerations, testing workload,efficiency of referral networks, and patient access to services. The Xpert MTB/RIF testing sites may belocated in a peripheral clinic, district laboratory, or a high-throughput reference laboratory. Eachtesting site should be evaluated for readiness using a standardized checklist prior to the testing ofclinical specimens. In addition, existing testing sites should be regularly assessed for safety andoperational functionality.Activities at a glanceNational, Regional, and District LevelTesting site levelAssess each testing site for readinessPlace the GeneXpert instrument correctlyand secure from theftUpgrade facilities as needed to create asafe functional work environmentEnsure an uninterrupted power supplyRegularly assess existing testing sites forsafety and functionalityEnsure an optimal working temperaturePerform a risk assessmentEnsure sufficient ventilation for testingproceduresProvide suitable PPE and train staff in itscorrect useDiscard waste as recommendedUse appropriate disinfectant and preparecorrectly8Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 7. Equipment and suppliesThe GeneXpert is a precision instrument that requires regular maintenance as described by themanufacturer to ensure that it provides accurate and precise results. A robust inventory system isrequired to monitor Xpert MTB/RIF cartridge consumption. Accurately forecasting Xpert MTB/RIF testsupply needs reduces the risk of service interruption due to shortage of cartridges and testing materials.Failure to maintain an adequate, uninterrupted supply of quality-assured reagents can affect qualitybecause 1) stock-outs result in delayed testing and delayed reporting of results and 2) use of poor qualityor expired reagents can result in high error rates and inaccurate test results. New lot testing, also knownas lot-to-lot verification, should be performed (at least at the national level) on new batches of cartridgesto ensure their fitness for use.Activities at a glanceNational, Regional, and District LevelTesting site levelDevelop and implement plans and policiesto ensure maintenance and servicing ofthe GeneXpert instrumentMaintain all testing site equipment in agood working conditionPerform preventative maintenanceEstablish a system to ensure anuninterrupted supply of quality-assuredreagentsMonitor instrument performance andperform on-request maintenance asrequiredImplement a system for new lot testing ofbatches of cartridgeEnsure warranties and service contractsare in place and adhered toForecast how many cartridges willbe usedImplement a stock control system tomanage Xpert MTB/RIF stockStore Xpert MTB/RIF cartridges inaccordance with manufacturer’srecommendations9Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 8. External quality assessment (EQA)An EQA program includes quality and performance indicator monitoring, PT, regular on-site supportivesupervision with timely feedback, corrective actions and follow-up. The Xpert MTB/RIF PT programmeis an important tool for communicating with and motivating staff. If used correctly, the PT programmecan identify and resolve problems in Xpert MTB/RIF testing. On-site evaluations and supportivesupervision can facilitate evaluation of the quality of testing, analyze QA results, identify problems,develop corrective actions, provide initial and refresher training, and document improvements. Failureto implement a comprehensive EQA program is a missed opportunity to identify and correct problemsthat affect the quality of testing.Activities at a glanceNational, Regional, and District LevelTesting site levelDevelop and implement a program foron-site supervision prioritizing poorlyperforming sitesEnroll the testing site in an Xpert MTB/RIFPT programmePerform PT testing as required. Receiveand analyse PT reportsDevelop and implement a PT programTroubleshoot unexpected PT results andidentify corrective actionsParticipate in a system of supportivesupervision and on-site evaluations10Quick Guide to Quality Assurance of Xpert MTB/RIF Testing
Element 9. Monitor performance of Xpert MTB/RIF testingand the QA/CQI systemRoutine monitoring of quality indicators, also known as performance indicators, is a critical element ofassuring the quality of any diagnostic test or system and is essential to inform decision-making. Qualityindicators should include testing site performance indicators, clinical indicators and programmaticindicators, including those that measure test results, supplies, test performance, PT results and QAprocesses. The Xpert QA Guide provides detailed descriptions of recommended key performanceindicators for monitoring the quality of Xpert MTB/RIF testing and targets for the indicators as wellthe key indicators for the quality of the diagnostic cascade and the overall QA system that should bemonitored at the supervisory or national level.All laboratories should collect and analy
Element 8. External quality assessment (EQA) 10 Element 9. Monitor performance of Xpert MTB/RIF testing and the QA/QC system 11 Element 10. Strengthen the clinical-laboratory interface and the diagn
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