As of February 11, 2021, this has been resolved. Testing has resumed at Spectrum Health Regional Laboratory Immunochemistry Department.
Starting November 1, 2020, the Lyme Total Antibody test will temporarily not be performed in-house and will be sent out to the Mayo Clinic Laboratories using the Lyme Disease Serology, Serum. This is due to the backorder of reagents from the vendor until approximately January 2021.
Lyme Disease Serology, Serum is available to order in Epic. Lyme Total Antibody will still be available to order, however, when the specimen arrives to the laboratory the order will be switched to the Lyme Disease Serology, Serum.
Similarly, to the current in-house test, the Mayo assay is also a Lyme total antibody assay, detecting both IgG and IgM antibodies, with the same specimen type as the in-house test. However, test turn-around-times may be increased.
Lastly, this change will have no effect on the reflexing of positive samples to the confirmatory Lyme Disease Antibody, Immunoblot, Serum.
As of August 26, 2020, the following tests will be obsoleted or made as lab orderables only. This was implemented to streamline protein electrophoresis orders and ensure that patients receive the recommended testing for the assessment of plasma cell proliferative diseases.
In addition to streamlining protein electrophoresis orders, order questions have been implemented to the available tests to access the reason for ordering to ensure that the proper reflex testing is applied.
For more information, see the lab test directory under the available tests for a protein electrophoresis orders tip sheet entitled “Orders- Protein Orderable Changes”
Effective April 22nd, 2020, the following ANA (Antinuclear Antibodies) Tests’ name will be updated. The change in naming convention comes in hopes of enhancing proper test utilization. This update includes only the name change with no changes in laboratory testing workflow.
The most conclusive evidence for using thyroid peroxidase antibody (TPO) is predictive in nature when evaluating possible subclinical hypothyroidism. If this test is positive, hypothyroidism occurs at a rate of 4.3% per year versus 2.6% per year when the antibody is negative. While this scenario does not cover all clinical indications for ordering TPO, there is no definitive evidence that repeat TPO testing provides additional information.1
Based on this information the ordering of TPO within Spectrum Health is being modified. If the test is ordered more than once on a patient, a screen will appear in EPIC indicating the following: “This test should typically only be resulted once per lifetime. The duplicate checking indicates that this patient has already had this testing performed. Please see chart review for results.” This is not a “hard stop” but providers will need to click “Continue” to proceed with the order.
In December, serum and urine protein electrophoresis testing will be simplified and standardized. The only testing available will be:
Protein electrophoresis, serum, IFE if indicated
Protein electrophoresis, random urine, do IFE if indicated
Protein electrophoresis, 24 hour urine, do IFE if indicated
In addition, on December 5, 2019, a new panel will be added which reflects expert recommendations for first line testing for monoclonal gammopathy, including plasma cell myeloma and most cases of amyloidosis, called “Monoclonal Gammopathy Screen”
Protein electrophoresis, serum, IFE if indicated
Kappa and lambda free light chains
Effective November 5th, testing for Beta-2 Glycoprotein 1 antibodies (IgG and IgM, serum) will change from a reference send out test to Mayo Medical Laboratories to an in-house test available at Spectrum Health Laboratories. This testing is useful for evaluation of patients of suspected antiphospholipid antibody syndrome.
In addition, a new Antiphospholipid Antibody Syndrome Panel will be added which allows for appropriate and complete testing for antiphospholipid antibody syndrome. This panel includes:
Cardiolipin IgG and IgM Antibodies
Beta-2 Glycoprotein 1 IgG and IgM Antibodies
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.
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.