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This will take effect April 17, 2012

Clinical Utility:

A positive bias has been observed for the current Thyroglobulin reagent. A nation-wide shortage has made it impossible to order replacements for our current reagents. Therefore, effective April 17, 2012 PathGroup will switch testing to an alternate platform which will result in a change to expected values and the Reference Range for Thyroglobulin Antibodies. Thyroglobulin autoantibodies (TgAb) are often present in patients with autoimmune thyroid disease. This assay is intended to be used as an aid in the diagnosis of Hashimoto’s and Graves’ diseases which are autoimmune diseases affecting the thyroid gland. This assay is also necessary to identify patients whose serum contains Thyroglobulin autoantibodies that may interfere with serum Thyroglobulin measurements.

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This change will take effect February 24, 2012

Overview and Clinical Utility:
Effective February 24, 2012 PathGroup will implement the Optimized Serum Thyroid Peroxidase Antibody Assay. This assay is intended to be used as an aid for in vitro diagnostic use in the quantitative determination of autoantibodies against thyroid peroxidase in serum using the ADVIA Centaur XP systems.

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This change will take effect February 24, 2012

Overview and Clinical Utility:
Effective February 24, 2012 PathGroup will implement the Optimized Serum Anti-Thyrogobulin Assay. This assay is intended to be used as an aid in the diagnosis of Hashimoto’s and Graves’ diseases which are autoimmune diseases affecting the thyroid gland.

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This change will take effect February 6, 2012

Overview and Clinical Utility:
Effective February 6, 2012, PathGroup will implement the Restandardized Serum Folate Assay. Folate is an essential vitamin vital to normal cell growth and DNA synthesis. Folate deficiency can be caused by insufficient dietary intake, malabsorption or excessive folate utilization which occurs very commonly during pregnancy, alcoholism, hepatitis, or other liver‐damaging diseases. World Health Organization Technical Consultation states that a folate less than 4 ng/mL is considered deficient and can lead to megaloblastic anemia and ultimately to severe neurological problems.

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This change will take effect December 15, 2011

Overview and Clinical Utility:
Effective December 15, 2011, PathGroup will change testing kits for Toxoplasma IgM testing in house. The Platelia Toxo IgM is an in vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, or Citrate). The Platelia Toxo IgM assay is presumptive for detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. The performance of the Platelia Toxo IgM assay has not been established for neonate testing.

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This change will take effect May 17, 2012

Overview and Clinical Utility:
Because of their low sensitivity, enzyme immunoassay (EIA) tests are no longer recommended for detection of C. difficile toxin in stool specimens.1 Recent literature indicates that nucleic acid amplification-based assays provide sensitivities and specificities comparable to toxigenic culture, the current “gold standard” and provide significantly shorter turnaround times.

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