In mid-September 2017, Spectrum Health Regional Laboratory Immunology department in collaboration with Spectrum Health Adult and Pediatric Rheumatology have made some adjustments to antinuclear antibody (ANA) testing (see below) options.
On May 1, 2017, Spectrum Health Regional Laboratory adjusted the reference range for C-Reactive Protein (CRP) from ≤10 mg/L to ≤5.0 mg/L.
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.
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.
On March 21, 2017, Spectrum Health Regional Laboratory (SHRL) will be switching instrument/vendors that perform the Beta CTX (BCTX assay); we will be switching from the ROCHE COBAS® platform to the ISYS-IDS platform. Both methods compare very well, however reference ranges will change due to the different methods.
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.
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.
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.