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

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.
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