Clostridium Difficile Toxin A and B by ELISA – Test Update

This will take effect March 10, 2014

Overview and Clinical Utility:

Beginning March 10, 2014, PathGroup Labs will discontinue testing for Clostridium difficile toxins A and B by ELISA methodology and will perform direct detection of toxigenic C. Difficile strains by DNA amplification. The test will be performed Monday through Friday and may be performed on pediatric as well as adult specimens. The DNA amplification method is more sensitive and specific than the ELISA test.

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Discontinuation of T-Uptake Testing – Test Update

This will take effect February 24, 2014

Overview and Clinical Utility:

On February 24, 2014, PathGroup Labs will discontinue T-Uptake Testing. Historically, T-Uptake testing was used primarily in conjunction with Total T4 to calculate the Free Thyroxine Index (FTI), a surrogate measure of Free T4. T-Uptake is of little clinical value alone; it’s primary use was for determining the FTI. Free T4, or Thyroxine Free, is readily available in almost all clinical laboratories and is the preferred test alternative to T-Uptake and the Free Thyroxine Index. The American Thyroid Association recommends first line screening for thyroid disorders with a high sensitivity (3rd generation) TSH assay. TSH may be ordered with reflex to Free T4, if abnormal. Note that custom panels with T-Uptake included will be amended. T-Uptake and FTI will be removed where applicable.

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Serum Protein Electrophoresis and Immunofixation – Test Update

This will take effect February 24, 2014

Overview and Clinical Utility:

Effective February 24, 2014, PathGroup will modify the available test codes for serum electrophoresis for ease of ordering for clients. Serum protein electrophoresis is generally performed when monoclonal gammopathy is suspected. Reasons for suspecting a monoclonal gammopathy include, but are not limited to: high total protein with a low A/G ratio; unexplained hypercalcemia, anemia, renal insufficiency, pathologic bone fractures and/ or lesions or peripheral neuropathy.

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SmartGenomics™ – 35 Gene Solid Tumor NGS and aCGH

This will take effect February 3, 2014

Overview and Clinical Utility:

PathGroup has increased regional coverage within our SmartGenomics™ solid tumor 35 gene next generation sequencing (NGS) panel from 112 to 140 amplicons in conjunction with a move of the test from the Ion PGM™ platform to the Illumina® MiSeq platform. Additionally, PathGroup has changed array comparative genomic hybridization (aCGH) platforms from the CombiMatrix DNArray™ Tumor Profile BAC array to the Illumina 850k CNV SNP array.

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Trichomonas Vaginalis Testing – Test Update

This will take effect January 8, 2014

Overview and Clinical Utility:

Effective January 8, 2014, Trichomonas Vaginalis testing will be performed by Qualitative Transcription-Mediated Amplification (TMA). Previously, Trichomonas Vaginalis testing was conducted by Direct Fluorescence; however the TMA methodology is preferred. Acceptable specimen types vary for males and females. Included are updated test codes for each gender.

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Bioavailable Testosterone (Women and Children) by LCMS

This will take effect January 20, 2014

Overview and Clinical Utility:

Effective January 20, 2014, PathGroup will insource Bioavailable Testosterone for Women and Children by LCMS. This test panel will include total testosterone by LCMS, Sex Hormone Binding Globulin (SHBG), free and bioavailable testosterone. This is an acceptable test in the evaluation of suspected hyperandrogenemia in women and children. The test panel is also acceptable for evaluating androgen deficiency in men.

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Egg Allergen Component Panel

This will take effect December 16, 2013

Overview and Clinical Utility:

Effective December 16, 2013, PathGroup will implement in-house testing for ImmunoCAP egg allergen component panel. Egg allergen component panel may be utilized to diagnose and manage egg allergic patients. ImmunoCAP allergen components help to differentiate between “true” allergies and cross-reactivity. A better differentiation helps to give relevant advice and define the optimal treatment. Proper management helps to improve the patient’s well-being and quality of life.

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Peanut Allergen Component Panel

This will take effect December 16, 2013

Overview and Clinical Utility:

Effective December 16, 2013, PathGroup will implement in-house testing for ImmunoCAP peanut allergen component panel. Peanut allergen component panel may be utilized to diagnose and manage peanut allergic patients. ImmunoCAP allergen components help to differentiate between “true” allergies and cross-reactivity. A better differentiation helps to give relevant advice and define the optimal treatment. Proper management helps to improve the patient’s well-being and quality of life.

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Group B Strep Detection by PCR – Test Update

This will take effect December 16, 2013

Overview and Clinical Utility:

Effective December 16, 2013, PathGroup will switch the current Group B Strep Detection by PCR assay to a new platform. The new assay will be the FDA-approved BD MAX™ GBS. The BD MAX™ GBS assay provides excellent clinical sensitivity (95.0%) and clinical specificity (96.7%) with an analytic sensitivity of only 200 cfu/ml.

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