Clinical guidelines no longer recommend serologic testing as a method for the diagnosis of H. pylori infection. Rather than IgG serology testing, other non-invasive testing methods such as H. pylori stool antigen and urea breath tests may be used to both diagnose and monitor response to therapy for H. pylori infection. In anticipation of an increase in stool antigen testing, currently a reference lab send-out test, Spectrum Health Regional Laboratory (SHRL) will be implementing this test as of October 29, 2018. By offering this test in-house, results will typically be available one day faster than present state.
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.
Spectrum Health Regional Laboratory is preparing to switch Clostridium difficile testing methods from solely using a molecular approach to a 2-step algorithm utilizing an Enzyme Immunoassay (EIA) that detects two C. difficile-specific proteins (glutamate dehydrogenase or GDH, and A/B toxin) with indeterminant EIA specimens reflexed to PCR (see flowchart below). It is estimated that approximately 90% of patients tested will be resolved by EIA and not require reflexive PCR testing. This algorithm decreases expenses to the patient by an average of 65% as compared to current testing without sacrificing result quality. Specimens will be batched for EIA testing at a frequency to ensure that results are available within 6 hours of receipt by the laboratory so that proper contact isolation precautions may be initiated when indicated.
As of January 30th, 2017 the test for Fecal Leukocytes will be discontinued and replaced with testing for Fecal Lactoferrin.
Effective August 18, 2016, the Spectrum Health Regional Laboratory Microbiology Department will begin offering the Verigene® Enteric Pathogens Test, a new rapid molecular test that simultaneously detects and identifies the following pathogenic enteric bacteria, viruses, and toxins that commonly cause acute community-acquired diarrhea. Testing occurs directly from stool in Cary-Blair preservative with a 1 day turnaround time (2-3 days faster than current methods).
The Spectrum Health Laboratory is now reporting all Hepatitis C Antibody results as Negative or Positive only. (Hepatitis C Antibody, Screening; Hepatitis C Antibody, Diagnostic) The separate Low Positive result category has been eliminated.
The Laboratory has changed to a new Hepatitis C Antibody reagent which no longer includes the Low Positive result category in its product labeling (the FDA approved instructions which laboratories are required to follow). The Low Positive category was defined on the basis of old guidelines which indicated that results above a defined S/CO (signal/cutoff) value were considered to have a 95% or greater probability of being true positives and did not require RIBA confirmation. The RIBA confirmatory test has not been available for several years now. Current guidelines are that all positive Hepatitis C Antibody tests should be confirmed with a HCV RNA test. The Spectrum Health laboratory reflexes all positive antibody results to this test. A positive HCV RNA following a positive antibody result should be considered indicative of active HCV infection, and may be used as a baseline for antiviral therapy.