HPV High Risk Screen by Roche cobas – Test Update

This will take effect October 20, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the availability of the FDA-approved Roche cobas® HPV assay effective Monday, October 20. This high-risk HPV test will replace the current Digene Hybrid Capture 2 assay. The new test will be performed on the fully automated cobas® 4800 System, for delivery of trustworthy results with PathGroup’s industry-leading turnaround time.

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Microsatellite Instability by PCR – Test Update

This will take effect September 2, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the availability of Microsatellite Instability (MSI) analysis by PCR (MSI). Microsatellite instability is a result of a deficiency in a specific type of DNA repair capability called Mismatch Repair (MMR). Cells deficient in MMR have a reduced capability of repairing certain types of damage that naturally occur in their DNA, specifically mismatched bases. This deficiency is apparent in the replication of microsatellite sequences. Such microsatellite sequences are typically replicated and maintain a constant number of repeats. In MMR-deficient cells, the number of repeats can increase or decrease. Tumors that display MMR show a change in the size of microsatellite sequences from those seen in non-neoplastic tissue and are said to display MSI.

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SmartGenomics NGS Solid Tumor + Heme – Test Update

This will take effect August 25, 2014

Overview and Clinical Utility:

PathGroup has made changes to both the solid tumor and hematomalignancy panels performed via Next-Generation Sequencing (NGS) as a part of SmartGenomics™ orders.

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BETA-HCG Testing – Test Update

This will take effect August 11, 2014

Overview and Clinical Utility:

Beginning the week of August 11, 2014, PathGroup Laboratories will change from the current Access Total βhCG assay to the new Access Total βhCG (5th IS) assay. Pathgroup’s vendor for Human Chorionic Gonadotropin, Beckman Coulter, recently introduced Access Total 5th IS. The new Total βhCG (5th IS) calibrators are standardized to the World Health Organization (WHO) 5th International Standard (NIBSC Code 07/364). The Access Total βhCG assay is the first βhCG assay to be standardized to the highly purified WHO 5th International Standard.

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Toxoplasma – Test Update

This will take effect August 4, 2014

Overview and Clinical Utility:

To improve performance and sensitivity of the Toxoplasma assay, PathGroup Labs will begin testing by Chemiluminescent Immunoassay for IgM Antibodies. The serological diagnosis of acute toxoplasmosis allows adequate treatment which reduces the risks of the disease both in immunocompromised patients and pregnant women.

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Maternal Serum Screen, Integrated – Test Update

This will take effect June 23, 2014

Overview and Clinical Utility:

Effective June 23, 2014, PathGroup will be insourcing maternal serum screening, integrated, to evaluate the risk for Down’s syndrome, Trisomy 18 and Open Spina Bifida. First specimen should be collected in the first trimester between 11 weeks and 13 weeks 6 days and Crown-Rump length (CRL) must be 4.2-8.5 cm. The second specimen should be collected in second trimester between 15 weeks and 18 weeks 6 days (optimal collection time frame) but can be collected until 21 weeks 6 days. Preliminary report after the first specimen will only have PAPP-A with final interpretation pending second specimen submission.

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Maternal Screen Testing Recalculation Request Form

Maternal Serum Screen Patient Information Form

Trichomonas Vaginalis By Aptima – Test Update

This will take effect June 9, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the immediate availability of the FDA-approved APTIMA Trichomonas vaginalis detection assay by Hologic. Trichomonas vaginalis is the most common curable sexually transmitted disease (STD) agent in the United States, with an estimated 7.4 million new cases occurring annually. Infections in women cause vaginitis, urethritis, and cervicitis. Discharge and small hemorrhagic lesions may be present in the genitourinary tract.

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Urine Protein Electrophoresis – Test Update

This will take effect May 19, 2014

Overview and Clinical Utility:

Effective May 19, 2014, PathGroup will implement in-house testing for Urine Protein Electrophoresis (UPE). Protein electrophoresis is a well-established technique routinely used for the screening of protein abnormalities. Urine protein electrophoretic patterns can classify proteinuria as glomerular, tubular, combined, stress or normal.

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HIV Confirmatory Testing – Test Update

This will take effect April 28, 2014

Overview and Clinical Utility:

PathGroup Labs will begin confirmatory testing for a positive HIV screen utilizing the Bio-Rad MultiSpot HIV1/HIV2 discriminatory assay and will discontinue confirmatory testing by Western Blot effective April 28, 2014. It is strongly recommended that patients whose positive screen is followed by a negative confirmatory assay be tested by Nucleic Acid Testing.

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HIV Confirmation Screening Algorithm

Celiac Disease Panel – Test Update

This will take effect April 14, 2014

Overview and Clinical Utility:

Effective April 14, 2014, PathGroup will change methodologies for the celiac disease panel (tissue transglutaminase and deaminated gliadin IgA and IgG). Methodology will change from enzyme immunoassay to multiplex flow immunoassay.

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