Effective immediately there has been an update to scheduling breath testing. Both the Bacterial Overgrowth and Lactose Intolerance breath tests must be scheduled through Epic or via Spectrum Health MyChart app.
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Compliance & Safety, General Information, Immunochemistry, Main lab
Serum Kappa/Lambda Free Light Chain Assay Update
Effective September 28th, 2020, a new generation of the serum kappa/lambda free light chain assay has been implemented.
With the implementation of the new generation of the assay there is an approximately 20% negative bias for kappa free light chains in serum containing >20 mg/dL kappa free light chain. This may affect the trending for patient who are serially monitored by this assay.
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”
Beginning September 8, at approximately 2PM, Spectrum Health Laboratories will go live with their new lot of APTT reagent. This lot change triggered a new therapeutic curve resulting in new heparin nomograms for the system. The standard heparin therapeutic range will change from the current 45-65 seconds to a new range of 37-52 seconds based off the new curve. Reference ranges for the APTT assay will also be updated. Grand Rapids APTT reference range will be 21-27 seconds and the Regional Hospitals will be 21-31 seconds.
APTT specimens that are unable to reach an endpoint (no clot is detected), will reflex to the Unfractionated Heparin (UFH) (Test Code LAB3389) anti-Xa assay. To accommodate this change, UFH values have been added to heparin nomograms. The UFH anti-Xa assay is currently only performed in the Grand Rapids labs and valid only for unfractionated heparin. Any questions concerning these changes may be directed to the Spectrum Health Regional Laboratory Coagulation department at 616-267-2740.
Test manufacturer supply chains continue to be disrupted due to COVID-19. Currently, there is a shortage of supplies for the Group B Streptococcus PCR test. Orders for this PCR test may continue to be placed, however, the SHRL Microbiology Department will perform a culture method until PCR supplies are available with appropriate charging and a reporting comment indicating that the culture was performed. The PCR test is normally resulted within 24-48 hours of specimen receipt in lab, whereas the culture method turnaround time may be 48-72 hours. An update will be posted when these PCR supplies are received, however, there may continue to be intermittent supply issues for this test. Additional test information can be found here.
Advanced Technology Laboratory, Compliance & Safety, Education & Training, General Information, Main lab, Microbiology, Molecular Diagnostics, Test Utilization
REMINDER: Herpes Simplex Virus (HSV) PCR and HSV Culture Orders
As of January 13, 2020, the Spectrum Health Microbiology Laboratory will switch any viral culture orders placed on cutaneous or mucocutaneous lesion specimens to molecular PCR testing as the preferred diagnostic method.
Please refer to these documents for specimen collection information and appropriate ordering codes:
Effective May 18, 2020, Spectrum Health Regional Laboratory is pleased to be offering in-house COVID-19 serology testing, with initial availability 1,000 tests per day.
What is Serology Testing?
• Serology testing measures the body’s immune response to COVID-19 infection in the form of antibody production against the SARS-CoV-2 virus.
• There is a single COVID-19 serology order available in Epic, however, the Spectrum Health laboratory performs two versions of antibody testing to increase specificity and avoid reporting false positive results. An initial screen will be used to measure total antibody (IgA, IgM, and IgG), and positives will be confirmed by a second method that is specific to IgG.
• Specificity is critical when the expected prevalence in a community is low. This serology testing is not expected to cross-react with other circulating coronaviruses that cause the common cold.
• A positive IgG result indicates previous infection with COVID-19, but does not indicate immunity or protection against future infection.
• This test should not be used to detect acute COVID-19 disease. Symptomatic patients suspected to have acute COVID-19 infection should be tested using a molecular assay.
• Whether positive or negative for the presence of COVID-19 antibodies, serology testing results do not support easing of behaviors such as social distancing, wearing masks, or hand hygiene.
Effective April 30, 2020, Spectrum Health Laboratories will no longer be performing the D-Dimer Semi-Quantitative assay. D-Dimer (quantitative) will be the only orderable for the D-Dimer assay. This D-Dimer will be reportable up to 35,000 ng/mL FEU. The cut-off value used in the diagnosis of venous thromboembolism (VTE), deep vein thrombosis (DVT), or pulmonary embolism (PE) remains at 500 ng/mL FEU. It is important to note inpatients can be (falsely) elevated in many underlying non-thrombotic conditions common in hospitalized patients.
Questions and inquiries regarding this change may be sent to the Coagulation Department using the “Contact Us” link above.
TEST INFORMATION
D-Dimer – [Epic Code: LAB313, Interface Code: 10123, CPT 85379]
Discontinued: D-Dimer Semiquantitative for DIC [Epic Code: LAB760, Interface Code: 10122, CPT: 85378]
General Information, Immunochemistry
Immunochemistry ANA (Antinuclear Antibodies) Testing Name Update
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.
| Old Test Name | New Test Name | Test Code | Clinical Utility |
| ANA (Antinuclear Antibodies) Screen, Double Reflex to ANA IFA Hep2 Titer and Pattern, and if positive to ANA antibodies | ANA screen | LAB1230491 | Preferred initial ANA screen for autoimmune connective tissue diseases. |
| ANA (Antinuclear Antibodies), Hep2 Substrate IFA with reflex to Titer and Pattern if positive | IFA ANA (Rheumatology)
|
LAB3540 | Preferred confirmatory ANA test for autoimmune connective tissue diseases. With ordering recommendations for rheumatology only. |
Effective March 4th, 2020, Thrombin Time will change from a sendout reference test performed by Mayo Clinic Laboratories to an in-house test performed by Spectrum Health Regional Laboratory. This test will be performed in the Coagulation Laboratory and will include a new reference range (please see link in Test Information below).
Thrombin Time is suitable for monitoring fibrinolysis therapy, screening for disorders of fibrin formation and in cases of suspected fibrinogen deficiency states. It is also useful for the differentiation between a heparin induced prolongation of the thrombin time and fibrin formation disorders.
For questions around this test, please contact the Coagulation Department at 616-267-2740.
TEST INFORMATION
Thrombin Time – Epic Code: #LAB11230581, Interface Code: #11230581, CPT: #85670