EN_A1M.doc - IMMAGE Immunochemistry Systems Chemistry Information Sheet A1M Alpha-1-Microglobulin REF(150 tests 447710 For In Vitro Diagnostic Use

EN_A1M.doc - IMMAGE Immunochemistry Systems Chemistry...

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IMMAGE ® Immunochemistry Systems Chemistry Information Sheet A1M Alpha-1-Microglobulin REF (150 tests) 447710 For In Vitro Diagnostic Use ANNUAL REVIEW Reviewed by: Date Reviewed by: Date PRINCIPLE INTENDED USE A1M reagent, when used in conjunction with IMMAGE ® Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of alpha-1-microglobulin (A1M) in human urine by rate nephelometry. CLINICAL SIGNIFICANCE Measurement of alpha-1-microglobulin in urine aids in the diagnosis of kidney tubular damage, which can occur in the course of nephritis, advanced diabetic nephropathy, after heavy metal exposure, and after dosage with nephrotoxic medications. 1,2,3,4,5,6 Elevated levels of alpha-1-microglobulin in patients with urinary tract infections indicate kidney involvement. 4 METHODOLOGY The A1M test measures the rate of increase in light scattered from particles suspended in solution as a result of complexes formed during an antigen-antibody reaction. CHEMICAL REACTION SCHEME SPECIMEN TYPE OF SPECIMEN Urine is the only sample type recommended. A1M 988616AF EN 06/16/2010 1 / 12
There are no special dietary requirements prior to sample collection. The type of sample collection depends on how results are to be reported. 1 For direct quantitative values , any urine sample is acceptable, with 24-hour collections preferable. 7,8 Centrifuge urine samples at 3,000 x g for 10 minutes prior to analysis to remove any cells or other debris. SPECIMEN STORAGE AND STABILITY Urine samples should be collected without a preservative and allowed to come to room temperature prior to use. Samples may be stored at +2°C to +8°C for up to 7 days. Frozen samples are not recommended. A DDITIONAL SPECIMEN STORAGE AND STABILITY CONDITIONS AS DESIGNATED BY THIS LABORATORY : SAMPLE VOLUME For sample volumes refer to the Sampling Template. CRITERIA FOR UNACCEPTABLE SPECIMENS Refer to the PROCEDURAL NOTES section of this chemistry information sheet. C RITERIA FOR SAMPLE REJECTION AS DESIGNATED BY THIS LABORATORY : PATIENT PREPARATION S PECIAL INSTRUCTIONS FOR PATIENT PREPARATION AS DESIGNATED BY THIS LABORATORY : SPECIMEN HANDLING S PECIAL INSTRUCTIONS FOR SPECIMEN HANDLING AS DESIGNATED BY THIS LABORATORY : A1M 988616AF EN 06/16/2010 2 / 12
REAGENTS CONTENTS Each kit contains the following items: QUANTITY 1 Antibody Antigen Excess Solution (AGXS) 2 1 INITIAL VOLUMES OF SAMPLE AND REAGENTS IN THE CUVETTE 21 µL 321 µL Antibody 21 µL Buffer 1 300 µL REACTIVE INGREDIENTS REAGENT CARTRIDGE CONSTITUENTS VOLUME A1M Antibody (processed goat sera) 3.9 mL A1M Antigen Excess Solution (antigen excess testing solution) 3.9 mL Sodium Azide (used as a preservative) < 0.1% (w/w) CAUTION Sodium azide preservative may form explosive compounds in metal drain lines. See National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards (8/16/76).

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