IMMAGE®Immunochemistry SystemsChemistry Information SheetA1MAlpha-1-MicroglobulinREF (150 tests) 447710For In VitroDiagnostic UseANNUAL REVIEWReviewed by:DateReviewed by:DatePRINCIPLEINTENDED USEA1M reagent, when used in conjunction with IMMAGE®Immunochemistry Systems and Urine ProteinCalibrator, is intended for the quantitative determination of alpha-1-microglobulin (A1M) in human urine byrate nephelometry.CLINICAL SIGNIFICANCEMeasurement of alpha-1-microglobulin in urine aids in the diagnosis of kidney tubular damage, which canoccur in the course of nephritis, advanced diabetic nephropathy, after heavy metal exposure, and afterdosage with nephrotoxic medications.1,2,3,4,5,6Elevated levels of alpha-1-microglobulin in patients withurinary tract infections indicate kidney involvement.4METHODOLOGYThe A1M test measures the rate of increase in light scattered from particles suspended in solution as aresult of complexes formed during an antigen-antibody reaction.CHEMICAL REACTION SCHEMESPECIMENTYPE OF SPECIMENUrine is the only sample type recommended.A1M988616AF EN06/16/20101 / 12
There are no special dietary requirements prior to sample collection. The type of sample collectiondepends on how results are to be reported.1For direct quantitative values, any urine sample isacceptable, with 24-hour collections preferable.7,8Centrifuge urine samples at 3,000 x g for 10 minutesprior to analysis to remove any cells or other debris.SPECIMEN STORAGE AND STABILITYUrine samples should be collected without a preservative and allowed to come to room temperature priorto use. Samples may be stored at +2°C to +8°C for up to 7 days. Frozen samples are not recommended.ADDITIONALSPECIMENSTORAGEANDSTABILITYCONDITIONSASDESIGNATEDBYTHISLABORATORY:SAMPLE VOLUMEFor sample volumes refer to the Sampling Template.CRITERIA FOR UNACCEPTABLE SPECIMENSRefer to the PROCEDURAL NOTES section of this chemistry information sheet.CRITERIAFORSAMPLEREJECTIONASDESIGNATEDBYTHISLABORATORY:PATIENT PREPARATIONSPECIALINSTRUCTIONSFORPATIENTPREPARATIONASDESIGNATEDBYTHISLABORATORY:SPECIMEN HANDLINGSPECIALINSTRUCTIONSFORSPECIMENHANDLINGASDESIGNATEDBYTHISLABORATORY:A1M988616AF EN06/16/20102 / 12
REAGENTSCONTENTSEach kit contains the following items:QUANTITY1AntibodyAntigen Excess Solution (AGXS)21INITIAL VOLUMES OF SAMPLE AND REAGENTS IN THE CUVETTE21 µL321 µLAntibody21 µLBuffer 1300 µLREACTIVE INGREDIENTSREAGENT CARTRIDGE CONSTITUENTSVOLUMEA1M Antibody (processed goat sera)3.9 mLA1M Antigen Excess Solution (antigen excess testingsolution)3.9 mLSodium Azide (used as a preservative)< 0.1% (w/w)CAUTIONSodium azide preservative may form explosive compounds in metal drainlines. See National Institute for Occupational Safety and Health Bulletin:Explosive Azide Hazards (8/16/76).