Technical Bulletins

This will take effect May 13, 2013

Overview and Clinical Utility:

PathGroup is now performing HPV Genotyping using the APTIMA HPV 16 18/45 assay by GenProbe. Genotyping will be performed upon client request based on an “HPV Positive – HIGH Risk” result. PathGroup’s HPV Genotyping is a qualitative assay for the three most common HPV genotypes (16, 18 and 45) – associated with approximately 80% of all invasive cervical cancers. This assay allows for rapid risk stratification and is ASCCP recommended for patients who are HPV positive high risk via DNA testing.

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This will take effect May 6, 2013

Overview and Clinical Utility:

Effective May 6, 2013, PathGroup will implement the QuantiFERON®-TB (QFT) Gold in-house test. The QuantiFERON®-TB Gold In-Tube assay is an innovative whole-blood test that measures the cell-mediated immune response of tuberculosis (TB) infected individuals.

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This will take effect April 22, 2013

Overview and Clinical Utility:

PathGroup is now reporting BCR/ABL [t(9:22)(q34;q11)] for confirmed CML patients on the International Scale (IS) of measurement. The efficacy of tyrosine kinase inhibitors (TKI) is routinely monitored with serial PCR analysis of BCR/ABL fusion gene expression. The National Comprehensive Care Network goal of therapy is achievement of a “major molecular response” (MMR), defined as a 3-log reduction in BCR/ABL to ABL fusion product. MMR is associated with excellent progression free survival.

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For non-CML patients, click Here to read more.

This will take effect March 28, 2013

Overview and Clinical Utility:

Effective March 28, 2013, PathGroup will implement in-house testing for 1,5 Anhydroglucitol (GlycoMark®). GlycoMark® is a newly FDA approved blood test which measures 1,5 anhydroglucitol (1,5-AG), a glucose analogue in serum or EDTA plasma, for the intermediate-term monitoring of glycemic control in individuals with diabetes.

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This will take effect February 4, 2013

Overview and Clinical Utility:

Effective February 4, 2013 PathGroup will implement ImmunoCAP allergy testing on the Phadia 250. ImmunoCAP specific IgE is an in vitro quantitative assay which measures the concentration of circulating allergen specific IgE in human serum or plasma samples. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

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This will take effect January 28, 2013

Overview and Clinical Utility:

Effective January 28, 2013, PathGroup will implement in-house testing for Fibrinogen and Factor VIII Activity.  Fibrinogen is a coagulation factor (Factor I) produced by the liver, and is essential for blood clot formation.  Low levels of fibrinogen are associated with bleeding commonly secondary to liver disease or Disseminated Intravascular Coagulation (DIC).  Fibrinogen is an acute phase reactant and elevated levels may be associated with inflammation.  Increased concentrations are associated with increased risk of atherosclerosis.

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This will take effect January 7, 2013

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This will take effect December 1, 2012.

Overview and Clinical Utility:

PathGroup’s Elizabethtown Patient Service Center will be moving from its current address (suite location) to a new address (suite location) effective December 1, 2012.  Contact information and operational hours remain unchanged.

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This will take effect October 26, 2012

Overview and Clinical Utility:

The Cervical DNA Dtex testing process has recently been improved and enhanced.  These improvements resulted in a lower abnormal cell threshold for test positivity as well as the establishment of a new threshold for test positivity based on excessive tetraploidy, as follows:

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This will take effect October 1, 2012

Overview and Clinical Utility:

Effective October 1, 2012, Syphilis treponemal antibody screening will be performed on the Diasorin Liaison XL using one-step chemiluminescence immunoassay. The presence of antibodies to Treponema pallidum specific antigen, in conjunction with non-treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection.

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This will take effect October 1, 2012

Overview and Clinical Utility:

Effective October 1, 2012, Vitamin D 25 Hydroxy will be performed on the Diasorin Liaison XL using chemiluminescent immunoassay. Vitamin D testing is used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.

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This will take effect September 24, 2012

Overview and Clinical Utility:

The Kleihauer-Betke Fetal Stain has been discontinued and replaced with Fetal Cell Assay by Flow Cytometry as the routine method to assess fetal-maternal hemorrhage quantification and recommended RhIG dosage.

The traditional slide based Kleihauer-Betke test is a time consuming method with high rates of inter-observer result variation and suboptimal precision.   A more accurate, improved methodology is achieved via the Fetal Cell Assay by Flow Cytometry.

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This will take effect September 24, 2012

Overview and Clinical Utility:

Effective Monday, September 24, 2012, PathGroup Labs will offer a nine (9) panel urine drug screen in which all positive results will automatically reflex for confirmation testing. The test code for this new drug screen is USDC. The UDSL drug screen will continue to be available and orderable.

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This will take effect July 16, 2012

Overview and Clinical Utility:

Effective July 16, 2012, Rubella IgM antibody testing will be performed in house on the Bioplex 2200 using a multiplex flow immunoassay methodology. Rubella IgM (German measles) is a viral infection with worldwide distribution. Testing immediately post-exposure is of no value without a later convalescent specimen. While the presence of IgM antibodies suggests current or recent infection, low levels of IgM antibodies may occasionally persist for more than 12 months post-infection or immunization.

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This will take effect July 16, 2012

Overview and Clinical Utility:

Effective July 16, 2012, Cytomegalovirus (CMV) IgM antibody testing will be performed on the Bioplex 2200 using a multiplex flow immunoassay methodology. CMV IgM is for the detection of human IgM antibodies to cytomegalovirus virus in human serum, as an aid in the determination of current or recent CMV infection.

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This will take effect July 9, 2012

OVERVIEW AND CLINICAL UTILITY:
Effective July 9, 2012, PathGroup Labs will only offer the following glucose tests. Test codes are unchanged, but test names have been standardized.  The test panels below and associated reference ranges are based on recommendations by ADA and ACOG.  Other glucose testing panels which are not endorsed by ADA or ACOG will no longer be available.  Random glucose reference ranges will also be updated.

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This will take effect May 14, 2012

OVERVIEW AND CLINICAL UTILITY:
Effective May 14, 2012, Free and Total Testosterone for females and children will be performed in house. The concentration of free testosterone is derived from a mathematical expression based on the measurement of testosterone by LC/MS and sex hormone binding globulin. This test is suggested for women and children due to the improved sensitivity of testosterone by LC/MS. Reference ranges for Total Testosterone and Free Testosterone will be updated based on our patient population. Testosterone, the major androgenic hormone in humans, is commonly measured to aid in the diagnosis of clinical conditions related to its excess or deficiency. In addition, testosterone measurements are used to monitor testosterone replacement or anti-androgen therapy.

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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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