25OH Vitamin D Total Assay - University of California, San Francisco

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UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CLINICAL LABORATORIES 6. LIAISON 25 OH VITAMIN D TOTAL SPECIMEN DILUENT is stored at 2 – 8˚C upon receipt. When stored and handled as directed, the reagent is stable until the expiration date. 7. LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS are stored at 2 – 8˚C upon receipt. When stored and handled as directed, the reagent is stable until the expiration date. Once the vials are opened, the reagents are stable for 4 weeks when properly stored. INDICATIONS OF REAGENT DETERIORATION When a control value is out of the specified range, it may indicate deterioration of the reagents or errors in technique. Associated test results are invalid and samples must be retested. Assay recalibration may be necessary. VI. WARNINGS AND PRECAUTIONS CAUTION For In Vitro Diagnostic Use. 1. This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate biosafety practices should be used for materials. 2. Some reagents used in this assay contain human source material and should be treated as potentially infectious. Each unit used in the preparation of this product has been tested by an FDA-approved method and found non-reactive for the presence of HBsAg, antibody to HCV and antibody to HIV1/2. While these methods are highly accurate, they do not guarantee that all infected units will be detected. This product may also contain other human source material for which there is no approved test. Because no known test method can offer complete assurance that hepatitis B virus, hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV) or other infectious agents are absent, all products containing human source material should be handled in accordance with good laboratory practices using appropriate precautions as described in the Centers for Disease Control and Prevention / National Institutes of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories.” 4th ed., May 1999. 3. Some reagents contain sodium azide as a preservative. Because sodium azide may form explosive lead azide or copper azide in plumbing, it is recommended that drains be thoroughly flushed with water after disposal of solutions containing sodium azide. 4. For a detailed discussion of safety precautions during system operation, refer to the LIAISON User Manual. HANDLING PRECAUTIONS Do not use reagent kits beyond the expiration date. 1. Contents of starter reagent bottles should never be pooled when replacing new containers with those in use, regardless of lot number. 2. Before placing an integral on the instrument, suspend the magnetic particles in the first compartment by placing the integral in the Xcelerator for 30 seconds, then rotate the compartment for an additional minute. Check that all particles have been resuspended. Place the integral into the reagent bay and allow the instrument mixing to proceed for at least 30 minutes prior to starting a test run. eterr:Library:Mail Downloads:25OHVitDTotal.doc Page 6 of 15
UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CLINICAL LABORATORIES 3. Before loading an integral onto the instrument, check reagent compartments for bubbles and liquid adherence to the covers; remove if present. 4. Newly prepared Wash/System Liquid must sit for 6 hours to de-gas prior to use on the instrument. 5. Wash/System Liquid tanks must be bleached monthly according to manufacturer’s recommendations and rinsed thoroughly to prevent build up of residue from Wash/System Liquid, which could affect background readings. See maintenance procedures. VII. CALIBRATION / CALIBRATION VERIFICATION 1. The predefined Master Curve is adjusted to a new instrument-specific curve using the two calibrators supplied in the Reagent Integral via the bar codes on the reagent integral label. 2. Renewed calibration is required: a. With each new lot of reagents (Reagent Intergral or Starter Reagents). b. Every 7 days. c. After each servicing of the LIAISON Analyzer. d. If quality controls are out of acceptable range. 3. Refer to the LIAISON Daily Quick Start Procedure for detailed information on how to perform an assay calibration. 4. Refer to Appedix II for detailed information on how to perform a Calibration Verification. VIII. QUALITY CONTROL LIAISON 25 OH VITAMIN D TOTAL CONTROL SET (with Bar Code Labels for Controls 1 and 2) 1. Controls are received in liquid form and require no further dilution prior to use. 2. The controls are stored at 2 – 8˚C upon receipt. When stored and handled as directed, the reagent is stable until the expiration date. 3. LIAISON 25 OH VITAMIN D TOTAL controls levels 1 and 2 are run each day of testing. IX. PROCEDURE ASSAY PROCEDURE For detailed instructions on the following steps, refer to LIAISON Daily Quick Start Procedure. For additional information on principles of operation, refer to the LIAISON User Manual. 1. Prepare the Analyzer. a. Prepare Reagent Intergals. b. Check Instrument Status. c. Check Status of Data from Prior Run. d. Check Printer Status. 2. Perform System Test. 3. Perform Calibration if required. 4. Run LIAISON 25 OH VITAMIN D TOTAL controls levels 1 and 2. 5. Program, place and run patient samples. eterr:Library:Mail Downloads:25OHVitDTotal.doc Page 7 of 15
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