Hemoglobin A1C Reference Ranges – Test Update

This change will take effect March 16, 2015

Overview and Clinical Utility:

Effective March 16, 2015, PathGroup will deploy updated Hemoglobin A1C reference ranges to correspond with current American Diabetes Association (ADA) guideline recommendations.

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Respiratory and Food Allergy Testing – Test Update

This change will take effect March 16, 2015

Overview and Clinical Utility

Effective March 16 2015, PathGroup will implement several changes to ImmunoCAP respiratory and food allergen panel testing. These changes reflect current industry demand and testing recommendations. Updates include testing for mouse urine allergen, revisions to all Regional Respiratory Profiles and additions to the Food Allergen Panel. Please refer to PathGroup’s Directory of Services (DOS) for individual test codes, new profiles and a full menu of respiratory and food allergen testing.

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Group B Strep Detection by PCR – Test Update

This change will take effect March 16, 2015

Overview and Clinical Utility

Effective March 16, 2015, PathGroup will change Group B Streptococcus (GBS) detection by routine culture to the FDA-approved BD MAX™ GBS assay, test code MGBS. The BD MAX™ GBS assay provides excellent clinical sensitivity and specificity, 95% and 96.7% respectively. PCR assays greatly increase sensitivity compared to the standard culture method for GBS screening.

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Urine Drug Screening – Test Update

This change will take effect March 2, 2015

Overview and Clinical Utility:

Effective March 2, 2015, PathGroup will begin screening for Oxycodone within the Drugs of Abuse 10 Panel Screen (UDSL) and Urine Drug Screen with Reflex to Confirmation (UDSC). As currently allowed, each component of the urine drug screen may be ordered as a standalone test.

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4th Generation HIV Testing – Test Update

This change will take effect January 19, 2015

Overview and Clinical Utility:

Effective January 19, 2015, PathGroup will insource 4th generation HIV testing. Compared to the 3rd generation HIV antibody-only test, the 4th generation HIV assay provides greater sensitivity due its ability to detect the p24 antigen and conventional HIV-1 and HIV-2 antibodies. The p24 antigen becomes elevated and detectable during the initial burst of viral transmission before an antibody response. The risk of contagion in individuals with an HIV infection is reported to be greater in early acute infections due to high viral load.

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Testosterone Assays – Test Update

January 13, 2015

Females and children under 13 years of age inherently produce lower testosterone levels than adult males. As a result, an alternative method with greater sensitivity for detecting lower levels of testosterone must be deployed. The preferred method for detecting lower levels of testosterone is by LC/MS. In an effort to ensure PathGroup clients are ordering the appropriate Testosterone assay based on a patient’s gender and/or age, please see the ordering information detailed below.

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Lipid Panel and Advanced Lipid Profile – Test Update

This change will take effect January 12, 2015

Overview and Clinical Utility:

Effective January 12, 2015, PathGroup will launch updated report formatting and testing utilities to the current Lipid Panel, and introduce a new Advanced Lipid Profile to aid in the determination of cardiovascular risk factors. Pertinent reporting updates to the current Lipid Panel include cardiovascular risk assessment classification, LDL cholesterol patient history with trend analysis, and test results reduced to clinically relevant data as recommended by the 2004 ATPIII guidelines.

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Lyme Testing Delay

December 18, 2014

Due to a nationwide manufacturer backorder of the Lyme disease assay, PathGroup is experiencing delays in patient testing for Lyme disease. We are working diligently with the Lyme assay manufacturer to receive the first kits that become available for production. Stability of all samples has and will be maintained during this delay. We apologize for any inconvenience this may cause you or your patients.

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CRP Testing – Test Update

On November 12, 2014, PathGroup Laboratories identified a consistent positive bias in CRP values of approximately 0.9 mg/dL. After thorough investigation, we found this number to be consistent across all values. We have corrected the problem and the bias no longer exists.

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Ebola Hemorrhagic Fever

Effective Immediately

PathGroup would like to partner with you in protecting your employees and others from unnecessary exposure during the current Ebola outbreak. Limiting the amount of handling of specimens obtained from patients with suspected Ebola virus disease (EVD) is critical.

Patients with known or suspected EVD should not be referred to a PathGroup Patient Service Center; nor should collection of any specimen types be performed by a PathGroup phlebotomist.

If you have specimens from patients that are being evaluated for EVD, providers must contact their local State Department of Health to expedite testing and prevent exposure to transportation personnel.

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