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

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UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CLINICAL LABORATORIES 6. Validate and print control and patient results. 7. Save the database to the designated flash drive. 8. Perform Daily Shut-Down procedure. 9. For optimal performance, it is important to perform routine maintenance as described in the LIAISON User Manual. Detailed instructions may be found in the DisSorin LIAISON Maintenance procedure. SPECIMEN DILUTION PROCEDURES Specimens with a 25 OH Vitamin D Total result of >150 ng/mL will be flagged as “>>”. Samples should be diluted with LIAISON 25 OH Vitamin D TOTAL Specimen Diluent. Note that all lots of specimen diluent are interchangeable between LIAISON 25 OH Vitamin D TOTAL Assay kit lots. Manual dilutions should be done as follows: a. A dilution of one part patient to 3 parts diluent is recommended, resulting in a 1:4 dilution. b. Mix specimen diluent thoroughly by gentle inversion prior to use. c. Add 75 µL of patient sample to 225 µL of specimen diluent. d. Mix well or vortex gently. X. RESULTING/REPORTABLE RANGE 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. Some results may contain information in the flags column of the report. For a description of the flags that may appear refer to the posted reference table or to the LIAISON Quick Guide Appendix, page 25. ANALYTICAL MEASUREMENT RANGE & REPORTABLE RANGE The analytical measurement range for the DiaSorin LIAISON 25 OH Vitamin D Total Assay is 4 ng/mL to 150 ng/mL. The lowest reportable value is 4 ng/mL, based on an inter-assay precision that approximates 20% CV (functional sensitivity). Values below 4 ng/mL should be reported as
XII LIMITATIONS OF PROCEDURE UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CLINICAL LABORATORIES 1. Assay results should be utilized in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population. 2. The antibody utilized in this assay will demonstrate cross reactivity to many dihydroxylated metabolites of vitamin D. However, in humans, these compounds are naturally present in picomolar concentrations. 3. Bacterial contamination or repeated freeze-thaw cycles (>3) may affect the test results. 4. A skillful technique and strict adherence to the instructions are necessary to obtain reliable results. 5. The concentration of vitamin D in a given specimen determined with assays from different manufacturers may vary due to differences in methods and reagent specificity. XIII SPECIFICITY/INTERFERENCES SPECIFICITY Data on the cross-reactivity of the antiserum used in this assay were obtained by spiking up to 100 ng/mL of the potential cross-reactant and assaying. The cross-reactivity of each compound, normalized to 25 OH Vitamin D3 is listed below. INTERFERENCE Steroid % Cross-reactivity 25 OH Vitamin D2 104% 25 OH Vitamin D3 100% Vitamin D2
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25OH Vitamin D Total Assay - University of California, San Francisco

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