Nhs health check internalexternal quality control table of. Page 2 setup test procedure take the time to examine and familiarize yourself with the contents of the alere cholestech ldx system. Patient care supplies kimberly clark alere hemopoint cholestech 10991. Drug testing supplies from clia waived,inc, drug tests. Alere cholestech ldx system user manual pdf download. Alere cholestech ldx analyzer system 7day rental 10959. The cholestech ldx system requires no user calibration. If the numbers are outside the printed range, call cholestech technical service at 18007330404. Work schedule changes from every other day to everyday.
All quality control procedures and followup actions should be documented. Record the result on the blood cholesterol quality control log. Complete procedure to check lipid profile by ldx machine. All content is posted anonymously by employees working at alere. Majority of the workers are temps that never get converted even after working years for the company. Cholestech ldx quick reference manual pdf download. Cholestech ldx test cassettes lipid profile cassettes.
Alere cholestech ldx system empowers people to lead longer, healthier and more active lives by providing easy to use, accessible diagnostic tools and information to healthcare practitioners in over 77 countries. Laboratory quality assurance and standardization programs. Class 3 device recall alere cholestech ldx analyzer and alere. Abbott test cassette for ldx cholesterol analyzer cassettes. To run a test, just add a sample to the cassette and place it into the analyzer. Shop online for a wide selection of abbott ldx multianalyte controls enables users to monitor the performance of the cholestech ldx system for commonly tested analytes.
Ecord the results in the optics check log each day. Customers was informed of the affected product, problem and actions to be taken. Cholestech is committed to helping office based healthcare providers to efficiently identify atrisk medical patients and treat them more effectively. Alere cholestech ldx system empowers people to lead longer, healthier and more active lives by providing easy to use, accessible diagnostic tools and information to healthcare practitioners in. The alere i instrument has a small footprint and easy to use graphical user interface for convenience within a busy hospital or pointofcare environment. The cholestech ldx system brings a wealth of benefits to healthcare professionals and patients. Data link provides you with quick and easy access to patient test resultsanytime and anywhere. Assayed quality control material for use with the cholestech ldx system. Alere cholestech optics check cassette 10228 medtek. Cholestech ldx system pointofcare lipid testing system. Alere determine hiv12 agab combo quick reference card.
While we work to ensure that product information is correct, on occasion manufacturers may alter their ingredient lists. The cholestech ldx system is the efficient and economical point of care testing for cholesterol and related lipids, and blood glucose. These tests are critical to learning about peoples bodies and making sure they can be at optimal health. Point of care testing for cholesterol and related lipids as well as blood glucose serve as specialized tools that provide information for immediate risk assessment and therapeutic monitoring of heart. Alere cholestech ldx glu lipid profile cassette 10pk 10991.
How the alere cholestech ldx analyzer works the alere cholestech ldx analyzer uses reflectance photometry the amount of light reflected from a solid surface to measure the amount of substances in blood. We recommend that you do not solely rely on the information presented and that you always read labels, warnings. Statistical quality control 102 basic approach to statistical quality control 103 the deming cycle 103 manufacturing to speci. Cholestech ldx multianalyte level 1 and level 2 controls. Page 5 qc schedule april december 2016 page 6 image log in and qc submission help sheet page 7 8. The cholestech ldx is a small, portable analyzer and test cassette system. These simple tests can be used to determine a patients risk for heart disease or to. Date patient id test results tech initials hgb gdl hct% 1 2 3 4 5 6 7 8 9 10 11 12 14 15 16 17 18 19 20 21 22 23 24 25 serial number cuvette lot number cuvette. Alere issued a recall notification to customers via telephone and email. Cholestech training for the alere cholestech ldx testing for total cholesterol, hdl, ldl, and triglycerides is an important step for patients, medical practices and corporate wellness programs to. Alere cholestech cholesterol testing machine medtek supplies. The system serves as a diagnostic tool that provides information for immediate risk assessment. Alere cholestech ldx system the cholestech ldx machine from alere is an efficient way for medical professionals to provide accurate cholesterol results to their patients in a short amount of time. Iqc and optic results were recorded by the operator and inspected by the laboratory on a monthly basis.
Class 2 device recall cholestech ldx lipid controls. Abbott cholestech ldx analyzer the cliawaived alere cholestech ldx analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in pointofcare lipid profile, cholesterol, and glucose testing. Alere cholestech ldx system medline industries, inc. Comparing the accuracy of 2 pointofcare lipid testing devices. We recommend the following quality control procedures for the alere cholestech ldx system. Article information, pdf download for comparing the accuracy of 2 pointofcare lipid. Internal quality control iqc checks were performed twice weekly using the twolevels of manufacturer supplied control materials. Cholestech corporation material safety data sheet section 1 identity name cholestech ldx test cassette address 3347 investment boulevard, hayward, ca 945453808 telephone number 800 7330404 for additional information contact technical service date prepared february 28, 2007 common name used on label cholestech ldx tc. Cholestech ldx analyzer lipid profile, cholesterol, and. Weqas hba1c quality control assessment external x delivered every other month, shipped in a clear plastic container via royal mail. Disclaimers i work for biositeinvernessalere alere produces testing devices for use at the pocso i have more data on the testing areas my company covers.
Quality control storage and handling of control material frequency of testing sample requirement logging results fingerstick procedure ancillary capillary tube requirements proper fingerstick procedure running a test troubleshooting user manual alere product support. The alere logo, alere and cholestech ldx are trademarks of the alere groups of. Positive internal control the pinkpurple control line. Alere cholestech ldx quality control optics log trilogy foundation. Alere cholestech lipid profile plus glucose cassette, 10box. Cholestech gdx analyzer user manual storage instructions display the cholestech gdx analyzer must be stored at a temperature cartridge this icon will be used with up and down between 10 and 35. Cholestech ldx lipid profile and glucose cassettes 10991. Thats why more healthcare professionals choose alere for pointofcare diagnostics. Cholestech 452 ldx cholesterol analyzer with printer r product code. Alere cholestech ldx patient result log stat technologies. This products resides on a fisher scientific gsa or va contract.
Internal quality control process user guide including log book. Check the control assay sheet for the correct sample setting for running controls. Quality control test with each new shipment andor each new lot date ch. The controls are used to verify your ability to perform the test and interpret the results. Actual product packaging and materials may contain more andor different information than that shown on our web site. Alere cholestech ldx optics check log stat technologies. To run a test, just add a sample to the cassette and place it in the analyzer. Comprehensive training guide for api, finished pharmaceutical and biotechnologies laboratories presents costeffective training courses that cover how to apply advances in the life sciences to produce commercially. Manual for the complete process to change testing modes. Weqas hba1c quality control assessment external page 3 weqas afinion lipid panel control. If you have questions, please contact alere san diego, inc at 18773088289. Date control cuvette result low liquid qc result high liquid qc result tech initials 1 2 3 4 5 6 7 8 9 10 11 12 14 15 16 17 18 19 20 21 22 23 24 25 1 2 3 4 5 6 7 8.
Pay careful attention to possible errors in technique. Kob alere cholestech ldx til professionelle abbott. These controls degrade rapidly and shoul d be run as soon as possible after receipt. Alere 10991 cholestech ldx lipid profile glu cassettes.
Alere determine syphilis tp accurate syphilis results in 15 minutes. Alere afinion hba1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin % hemoglobin a1c, hba1c in human whole blood afinion hba1c control contains liquid preparations of stabilized porcine whole blood control c i and human whole blood control c ii more information. Class 2 device recall alere cholestech ldx analyzer. Cholestech ldx system quality control log we have provided you with a log sheet that can be duplicated and used for your records when you test quality control materials on the cholestech ldx system. This diagnostic tool provides information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. The cholestech ldk analyzer measures total cholesterol and hdl cholesterol by an enzymatic method based on the.
Cholestech training for the alere cholestech ldx youtube. Performance evaluations on the alere cholestech ldx system. Alere cholestech ldx system waived laboratory procedure. Kob alere cholestech ldx hos abbott tidligere abbott. The easytouse alere cholestech ldx analyzer provides a complete lipid profile as recommended by national guidelines. Manufacturing to reduce variations 104 process control in service industries 105 customer defections. Alere cholestech ldx efficient and economical point of care testing for cholesterol and related lipids, and blood glucose serve as diagnostic tools that provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Abbott cassette cartridges for cholestech ldx system. Alere afiniontm as100 analyzer system intended use alere afinion as100 analyzer with alere afinion data connectivity converter adcc is a compact multiassay analyzer for pointofcare testing, designed to analyze the alere afinion test cartridges. Alere cholestech ldx quick reference manual pdf download.
Additionally, alere cholestech cholesterol cassettes show the results quickly. Ensure that all results are within established ranges. Alere hemopoint h2 system h2 qcqa result log meter serial number control cuvette lot number control cuvette target value lot number exp. Cholestech hemoglobin analyzer offers efficient and economic diagnostic testing at the point of medical care for cholesterol and related lipids, liver function and blood glucose and glycemic control. Alere determine tb lam ag screen in just 25 minutes for hivassociated tb. Open the drawer perform a fingerstick collect the sample dispense the sample connecting the alere configuration menu cholestech ldx analyzer. Alere cholestech ldx lipid profile glucose cassettes 10991 box of 10 tests lipid profileglu cassette measures total cholesterol tc, a measure of the total amount of cholesterol in the blood, high density lipoprotein hdl cholesterol good cholesterol, and triglycerides or trg fatty acids and glycerol that circulate in the blood and are stored as body fat as well as glucose glu. Cholestech ldx cassettes cholestech machine wilburn. More so in emergencies where speed of delivery overshadows aspects or activities that would otherwise provide checks and balances in a sector that already has so much at stake. Class 3 device recall alere cholestech ldx multianalyte controls.
The measure of service process quality 105 process control for internal services 106 quality function. Cholestech ldx measuring instruments pdf manual download. Our website helps you find all the top quality medical supplies so that you may order hospital supplies quickly and easily at a low cost. The cholestech ldx system is designed to combat americas number one killer, heart disease. Quality control external quality control material should be run routinely to show that your system is giving accurate results. If you are viewing this page as a nonregistered user, the prices displayed is list price. Diagnostic products quidel 3m health care coaguchek xs. Abbott cholestech ldx analyzer ldx lipid monitoring system.
With just a drop of blood, this system can provide a descriptive profile on hdl, ldl, total cholesterol, triglycerides, and other information. For your alere cholestech cholesterol test cassettes, click on any of the links on the page or give us a call today at 80156339. Alere datalink dx is our online reporting and test management system specifically designed for our clinical clientele. Negative background control the clear background in the test window. Our experience is that the ldx instrument, in the hands of trained nonlaboratory staff, does generate reliable results, due to the instrument design and the quality control mechanisms we have added. Customers were instructed if they have the affected lot contact the alere technical service department at 8773088289 to report this lot and receive a free replacement. Written to help companies comply with gmp, glp, and validation requirements imposed by the fda and regulatory bodies worldwide, quality control training manual. To view your gsa or va contract pricing, log in using your account number, or become a registered user by contacting one of our customer service teams.
Browse technology quality control ebooks to read online or download in epub or pdf format on your mobile device and pc. Verify that the dating of the reagent cassette and quality control material has not been exceeded. Alere cholestech ldx system efficient and economic pointofcare testing for cholesterol and related lipids, blood glucose and glycemic control, and liver enzymes provides information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and. The amount of color formed is converted by the analyzer to a. A statistical approach to the principles of quality control and management, incorporating modern ideas, methods, and philosophies of quality management, fundamentals of quality control and.
The analyzer measures color changes of the four reagent pads. Now including hgtv, food network, tlc, investigation discovery, and much more. In a few minutes the results will appear on the screen. To learn more contact your local account executive. For all testing you will need to ensure you order enough alere test cassettes to carry out quality control. Alere san diego is recalling the alere cholestech ldx multianalyte control because the assigned control ranges for the total cholesterol tc and triglyceride trg analytes are incorrect. Nhs health check internalexternal quality control table.
Two levels of controls must be run on each day of patient testing. Wilburn medical provides convenient online ordering and our shipping is quick and. Quality control qc is an aspect of logistics management that is rarely applied, partially applied or completely ignored. Cholestech lcs multianalyte controls by abbott medline. It is easy to use and gives fast and reliable results. The alere cholestech ldx system is an easy to use system providing diagnostic tools and information to various health care providers worldwide. The alere logo, alere and cholestech ldx are trademarks of the alere groups of companies. Alere pima cd4 absolute cd4 count in less than 20 minutes. Alere cholestech ldx quality control log 2016 alere. The alere logo, alere and cholestech ldx are trademarks of the alere groups. If you have an individual subscription to this content, or if you have. Alere determine tm hiv12 agab combo controls are available separately and are for use only with alere determine tm hiv12 agab. Run the optics check cassette and quality control material before running patient samples. Cholestech ldx system certification quiz proprofs quiz.
Alere hiv combo 4th generation, delivering results in just 20 minutes. All aspects of the quality assurance program should be. Alere q hiv12 detect accessible, molecular testing in. Mix quality control material well by gentle inversion before use, and follow the same procedure used for testing patients samples. Fundamentals of quality control and improvement authors.
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