For determination of hemoglobin a1c in human whole blood. Afinion test cartridges, is for in vitro diagnostic use only. Abbott alere afinion as100 analyzer, abbott cardiometabolic. Afinion as100 analyzer for hba1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin % hemoglobin a1c, hba1c in human whole blood. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies. Alere afinion acr is a fully automated in vitro diagnostic test for.
Afinion 2 analyzer is a compact multiassay analyzer for pointofcare testing and is designed to analyze the afinion test cartridges. Selfstudy packet hemoglobin a1c johns hopkins pathology. Abbott alere afinion as100 analyzer community, manuals and. Abbottafinion 2 analyzer, tests and controls kit afinion 2. The johns hopkins hospital pointofcare testing program self. Afinion testsystem har utformats for att mojliggora snabb och enkel analys pa plats, oberoende av provtyp, vilket kan vara helblod, plasma eller urin, och ge korrekta resultat under patientkonsultationen for en forbattrad patienthantering. Control material afin ion hba1c control ref 1115178 is recommended for routine quality control testing. Afinion hba1c is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin a1c in human whole blood. The alere afinion crp test cartridge must reach an operating. Afinion hba1c test cartridges can be stored unopened at room.
Afinion hba1c is one ofthe first tests developed for the afinion as100 analyzer. It utilizes the latest technology and provides a simple, fast and reliable method by which to monitor patients disease progression. A clia certificate of waiver is needed to perform testing in a waived setting. The system, including both hba1c and ac r assays and the afinion. Mideast snow interactive code british town hopes king richard. The analyzer is designed to enable simple and fast onthespot testing, regardless of the sample type, which may be whole blood or urine, and to deliver accurate results during patient consultation for improved patient. Afinion hba1c as100 cartridges hemoglobin test box of 15. Abbottafinion 2 analyzer, tests and controls kit afinion. The afinion as100 analyzer provides valuable nearpatient testing. Afinion 2 user manual us 3 intended use of the afinion 2 system afinion 2 system, consisting of the afinion 2 analyzer and the afinion test cartridges, is for in vitro diagnostic use only. Omgaende hba1c resultater pa behandlingsstedet med henblik pa effektiv overvagning af glyk. Multiple sample types the alere afinion as100 analyzer is designed to enable simple and fast onthespot testing, regardless of the sample type, which may be whole blood, plasma or urine, and to deliver accurate results during patient consultation for improved patient management. Pocd afinion as100 hba1c method and sample collection.
The afinion as100 test cartridges and control solutions are stable until the manufacturers expiration date when stored refrigerated, 2 8c 36 46f. Alere afinion tm acr microalbumin test for quantitative determination of albumin, creatinine and albumincreatinine ratio acr in human urine, used for early identification of renal disease in patients with diabetes andor hypertension. Afinion analyzer system suitable for both laboratory and nonlaboratory users. The system, including both hba1c and ac r assays and the afinion as100 a nalyzer. When the cartridge enters the analyser, the integrated camera reads the barcode. Abbott afinion analyzer abbott rapid diagnostics ab. Afinion 2 installation and training abbott point of care.
Afinion as100analyzersystem,consistingoftheafinionas100analyzerandtheafiniontest cartridges,isforin vitro diagnosticuseonly. The johns hopkins hospital pointofcare testing program. November 29, 2018 alere technologies as monica vallestad. The afinion hba1c test cartridges can be stored in unopened foil pouches at room temperature for 90 days afinion as100 analyzer is designed to enable onthespot testing, regardless of the sample type, which may be whole blood, plasma or urine, and to deliver accurate results during patient consultation for improved patient management. Abbott afinion 2 user manual pdf download manualslib. Consult the package insert that comes with each afinion test kit for assay specific information. Hba1c screening will only be offered to people previously diagnosed with diabetes. Afinion hba1c is waived under the clinical laboratory improvement amendment of 1988 information codes and messages caused by analyzer failure. Connect the alere afinion to your ehr with relaymed. Alere afinion hba1c user manual alere afinion hba1c control log 1.
Multiple sample types the alere afinion as100 analyzer is designed to enable simple and fast onthespot testing, regardless of the sample type, which may be whole blood, plasma or urine, and to deliver accurate results during. Alere afinion 2 analyzer 1116554 at no charge with the. Alere afinion as100 analyzer thofu investments limited. Multiple sample types the analyzer is designed to enable simple and fast onthespot testing, regardless of the sample type, which may be whole blood, plasma or urine, and to deliver accurate results during patient. Alere afinion hba1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin % hemoglobin a1c, hba1c in human whole blood afinion. The sample material is collected with the integrated sampling device before. The afinion hba1c test cartridges can be stored in unopened foil pouches at room temperature for 90 days. Page 30 alere technologies as service representative. Powers on and completed self test and ready for cartridge as shown in picture. The alere afinion as100 analyzer is a compact rapid, multiassay analyzer that provides valuable near patient testing at the pointofcare. From just a small urine or fingerstick whole blood sample, labaccurate results for acr and hba1c are made available during the consultation. Alere afinion as100 3 x 15 tests clia waived hba1c. The abbott alere cholestech afinion 2 analyzer makes it fast and easy to test quantitative determinations of hba1c and acr. Alere afinion hba1c glycated hemoglobin hba1c in whole blood to monitor metabolic control in patients with diabetes.
Med afinion 2 analyzer kan du snabbt och enkelt kan gora kvantitativa analyser av hba1c, lipidpanel, acr och crp. Alere afinion hba1c dx analytic performance of afinion a1c is indisputable in laboratory settings the code is explained in the user manual. The afinion hba1c dx is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin a1c in human whole blood. The alere afinion as100 analyzer makes it fast and easy to test quantitative determinations of hba1c, lipid panel, acr, and crp. Hba1c must reach a temperature of 1830c before use. Data connectivity converter adcc, alere afinion test cartridges and alere afinion controls is for in vitro diagnostic use only. Hemoglobin a1c screening performed using the afinion as100 analyzer machine by trained personnel is intended to provide a rapid nondiagnostic, hba1c screening result that identifies whether a hba1c level is within the expected range, or impaired. Alere afinion as100 user manual us english diabetes management at the pointofcare presentation english implementation of hba1c point of care testing in.
During manufacture, afiniontm as100 analysers are calibrated against a reference system. Afinion hba1c test cartridges can be stored unopened at room temperature 1525c or 5977f for 90 days. External validation and lay user field studies ofafinion. Lipid panel must reach a temperature of 1830c before use. Measurement ofhba1c with afinion as100 analyzer demonstrates robustness,simplicity and insignificant risk oferroneous results. This user manual is valid for the afinion tests waived under the clinical laboratory improvement. The analyzer displays an information code that can be interpreted by the operator using the analyzer b code 201. Afinion hba1c analysen er en test til kvantitativ bestemmelse af glykeret h. This product can only ship to a medical or an educational facility.
Abbott alere afinion as100 analyzer manuals and documents. Afinion as100isacompactmultiassayanalyzerforpointofcaretesting. Interpretation of results interpret the alere afinion crp test results with careful consideration to the patients medical history, clinical examinations and other laboratory results. Alere afinion hba1c hemoglobin and acr analyzer ebay. Alere afinion hba1c hemoglobin analyzer as100 for sale online. Congratulations on the purchase of your afinion as100 analyzer.
The afiniontm hba 1c is traceable to the ifcc reference method for hba 1c. Control material afinion hba1c control ref 1115178 is recommended for routine quality control testing. Abbott alere afinion as100 analyzer community, manuals. The afinion hba1c assay is a test for quantitative determination of glycated hemoglobin hba1c in human whole blood, used to monitor metabolic control in patients with diabetes. Successful performance and documentation of quality control 2 levels of controls b. Afinion hba1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin % hemoglobin a1c, hba1c in human whole bloodafinion. The alere afinion crp quick guide also provides an illustrated stepbystep procedure. Oct 03, 2019 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. The afinion test system utilizes the latest technology and provides a simple, fast, and reliable method by which to monitor patients disease progression. 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. The afinion hba1c assay, for the alere afinion 2 analyzer, is a test for quantitative.
Alere afinion as100 3 x 15 tests clia waived hba1c placement. Information codes specific for the afinion hba1c assay. Alere afinion acr albumin, creatinine and albumincreatinine ratio acr in urine for early detection of renal disease in patients with diabetes andor hypertension. The afinion hba1c dx is a modification of the existing device, alere afinion hba1c for use with the alere afinion as100 analyzer, with the addition of a diagnostic intended use. Frequency of control testing controls should be analyzed. Accessgudid alere afinion hba1c 07070060005683 hemoglobin a1c test kit. The alere afinion as100 analyzer makes it fast and easy to test quantitative determinations of hba1c and acr. It is designed to analyse the afinion test cartridges. The afinion as100 analyzer connect comprises of the afinion as100 analyzer and the afinion data connectivity converter. The afinion hba1c test cartridge contains all of the reagents necessary for the determination of % hba1c. Consult the afinion hba1c package insert, section test result reporting. May 2016 product focus diabetes medical laboratory observer. This procedure has been established for each lot of test cartridges and then stored in the barcode label.
The afinion hba1c assay is a test for quantitative determination of glycated hemoglobin hba1c in human whole blood, used to monitor metabolic control in. Afinion as100 is a compact multiassay analyzer for pointofcare testing. Alere afinion hba1c is waived under the clinical laboratory improvement amendment information codes caused by sample or test cartridge. Af1116069 alere afinion lipid panel 15t af1116072 alere afinion lipid quality controls 2 x 1. Afinion 2 system is ideal for pointofcare testing in physician offices, clinics, community health centers and hospital outpatient clinics. Afinion hba1c control according to regulation ec no. Member of militant internet forum requests plane hijacking manual a militant islamist internet forum member going by the name deeb mohammed. The alere afinion acr assay with acr controls for use with the alere afinion as100 analyzer was cleared under k072409. Afinion hba1c as100 cartridges hemoglobin test box of. Afinion 2 analyzer user manual afinion hba1c error code. Afinion instrument abbott rapid diagnostics ab alere. 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.
752 378 989 1621 630 610 1765 593 125 534 46 1230 1667 1312 199 770 830 1694 1016 171 985 521 527 223 431 200 1863 1199 909 1110 509 384 1448 1787 724 908