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|Test Update Information||Anti-thyroglobulin antibody reference range changed effective July 1, 2014|
|Test group||Thyroid tests|
|Performed by||China Basin Chemistry|
|In House Availability||Tuesday, Friday (day shift)|
|Method||Chemiluminescent Microparticle Immunoassay-Abbott Architect i2000|
|Container type||Gold top|
|Amount to Collect||2 mL blood|
|Preferred volume||1 mL serum|
|Min. Volume||0.15 mL serum|
|Processing notes||Freeze serum at -20C.|
|Normal range||< 2.00 IU/mL
Reference range is based on the functional CV cutoff (20% CV cutoff) for the assay estimated by monitoring the CV in low end patient pools and samples tested over periods of 1 - 6 months. This functional CV cutoff is in accord with that reported by Pickett et al, Ann Clin Biochem, 49:463-467, 2012 for the Abbott Architect assay. Approximately 80% of healthy subjects with normal thyroid function tests and no thyroperoxidase antibodies will have an anti-TG antibody level < 2.00 IU/mL in this assay. The normal range cutoff has been set at the lower reporting limit of the assay (functional CV cutoff) in accordance with the view that any detectable level of anti-thyroglobulin antibody may be considered abnormal and might negatively interfere in the thyroglobulin assay.
|Stability||Refrigerated 7 days, frozen 1 month.|
|Turn around times||1-5 days|
|Additional information||This assay is automatically performed and reported whenever a thyroglobulin test is ordered. The presence of anti-thyroglobulin antibodies can variably interfere in thyroglobulin immunoassays and tend to falsely lower thyroglobulin results.
Note: Assays for anti-thyroglobulin antibodies are not well standardized and results with this Abbott Architect assay should not be directly compared with the results of other anti-thyroglobulin antibody assays.
The Architect anti-thyroglobulin assay is more sensitive for detection of anti-TG antibodies than other commonly used anti-TG antibody assays including the Siemens Immulite assay when using cutoffs based on the manufacturer's reference range or functional CV cutoff in some cases (Pickett et al. Annals of Clinical Biochemistry 49:463-467, 2012). The coefficient of variation of this assay is approximately 20% at a level of 2.00 IU/mL and approximately 6% at a level of 4.11 IU/mL. Results below the functional CV cutoff of 2.00 (20% CV cutoff) are reported as <2.00.
|Last Updated||7/1/2014 8:31:03 AM|
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