Browsing Tag

David Alter

Compliance & Safety, Toxicology

Urgent Notice: Lead Testing

On May 17, 2017, the US Food and Drug Administration (FDA) issued a safety communication warning against using venous samples on Point of Care Magellan Diagnostics LeadCare Testing System devices (LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra). Venous specimens appear to be at risk for having falsely low results.  Only Capillary (“finger stick” or “heel stick”) specimen types should be used.

IF YOUR OFFICE IS USING ANY OF THE MAGELLAN LEADCARE TESTING SYSTEM DEVICES: please DISCONTINUE the use of VENOUS specimens for testing. Continue Reading

Immunochemistry, Test Utilization

Utility of specific IgE (sIgE) testing to foods and food allergen components

The diagnostic evaluation of allergic disease occurs in the context of a patient’s complete clinical presentation. Important factors include, age, clinical signs and symptoms, relevant allergen exposures, and the performance characteristics (sensitivity, specificity, and predictive values) of the allergy tests themselves. Allergy tests yield information about sensitization to allergens, which is not always equivalent to allergic hypersensitivity (i.e., sensitivity); thus, interpretation in the context of clinical history is essential for accurate diagnosis. Continue Reading

Immunochemistry

dsDNA Antibody Update

Effective March 20, 2017, Spectrum Health Regional Laboratory’s Immunology department will be switching dsDNA vendors from Varelisa ™ to ThermoFisher/Phadia ™.

Both manufacturers (mfr) have similar methods but different reference criteria presumably due to manufacturer specific dsDNA epitopes identified.

The interpretive cutoffs will be changing, please refer to the table below. Continue Reading

Chemistry, Immunochemistry

Growth Hormone Update

As of February 7, 2017  the method/instrument used for the  Growth Hormone assay performed at the Spectrum Health Regional Laboratory will be switched from ROCHE COBAS to the IDS- iSYS. A method comparison between the two methods showed excellent clinical and numerical comparability. The assay also performed excellently in terms of precision and linearity. Continue Reading

Chemistry

Important Cardiac Marker Notification – Spectrum Health Reed City Laboratory

Spectrum Health Reed City Laboratory will be switching instrument vendors, from Beckman Coulter to Roche, Tuesday November 29th, 2016. The change will be seamless for all tests except Troponin and B-type Natriuretic Peptide, as both of those tests are specific by vendor they will change to reflect those of the new vendor.

  • Troponin I will be switched to Troponin T.
  • BNP will be switched to NT-ProBNP.

New cardiac marker numerical results and reference ranges will not be interchangeable with the old.  The new markers are consistent with what is in place at Spectrum Health Grand Rapids, Gerber and Zeeland Hospital Laboratories. Spectrum Health Big Rapids, United and Kelsey Hospital Laboratories will be following suit over the next 12 months. Continue Reading