Browsing Tag


Advanced Technology Laboratory, Cytogenetics, Molecular Diagnostics, Test Spotlight

Lung Cancer Mutation Analysis Panel provides targeted treatments for patients

The treatment of non-small cell lung adenocarcinoma has become more successful due to targeted treatments based on the molecular profile of a patient’s particular tumor. The Lung Cancer Mutation Analysis panel is now available for clinical testing at the Spectrum Health Advanced Technology Laboratories (ATL).  Continue Reading

Chemistry, Referral/Sendouts, Test Utilization

Appropriate Thyroglobulin Tumor Marker and Anti-Thyroperoxidase Ordering Practices

Thyroid Peroxidase Antibody (anti-TPO), Blood Level (Test #8524 )
This is the recommended test for the evaluation of Autoimmune Thyroiditis

Thyroglobulin, Tumor Marker, Serum (Test #3069)
It is only indicated for monitoring of thyroid cancer treatment.
This result is reported with an Anti-Tg result to assess for possible interference.
This test should NOT be ordered for associated anti-Tg result provided by reference laboratory.

Thyroglobulin Antibody (anti-Tg) Test
Historically ordered with anti-TPO for evaluation of possible autoimmune thyroiditis.
The literature shows that anti-TPO, alone, has better sensitivity and specificity with only 5% of cases of Autoimmune thyroiditis with anti-TPO negative, anti-Tg positive.
Since 2/2011, requests for anti-Tg have been cancelled per Laboratory Communication: Memo Thyroglobulin Antibody 2/2011

Spectrum Health Regional Laboratory Experience February 2015 – March 2016 (13 months):
357 patients with both Anti-TPO and Anti-Tg results.
*Anti-Tg results were due to concomitantly ordered Thyroglobulin TM requests.
250 patients had positive Anti-TPO and/or Anti-Tg level
193 patients had both positive Anti-TPO and Anti-Tg level
56 patients had positive Anti-TPO and negative Anti-Tg level
1 patient had a negative Anti-TPO and positive Anti-Tg levels

Based on these results, and what is reported in the literature, we are confident of our current practices and strongly request discontinuation of Thyroglobulin TM requests for the associated Anti-Tg result

Caturegli P, De Remigis A, Rose NR. Hashimoto thyroiditis: clinical and diagnostic criteria. Autoimmun Rev. 2014 Apr-May;13(4-5):391-7


Afirma® Gene Expression Classifier is Now Available at Spectrum Health

Spectrum Health Hospital is pleased to offer patients access to Afirma® Gene Expression Classifier (GEC), a molecular test that helps diagnose thyroid nodules from the first fine needle aspiration (FNA) biopsy.

Patient’s with thyroid nodules often undergo unnecessary surgery, with 70-80% of indeterminate nodules being benign upon surgical histopathology.1-2 By using Afirma GEC in these cases, we can reclassify about 50% of indeterminate thyroid nodules as benign,3 which helps resolve diagnostic uncertainty and reduce unnecessary surgery. Additionally, when cytopathology is malignant or suspicious for malignancy, Afirma Malignancy Classifiers (Afirma MTC and Afirma BRAF) provide actionable insight to help inform the choice of surgery.

Afirma GEC is well validated, including a multi-center, prospective, blinded study published in the New England Journal of Medicine.3 The Afirma solution represents a new standard of care for thyroid nodule patients. Afirma GEC is consistent with molecular testing recommendations from the National Comprehensive Cancer Network, UpToDate and American Thyroid Association guidelines.

Afirma GEC integrates into our thyroid diagnosis process through the following steps:

  •  During the first FNA, perform two extra passes in order to collect and store a separate sample in the event Afirma GEC analysis is needed.
  •  Spectrum Health Regional Lab will perform standard cytopathology and provide a diagnosis.
  •  If the cytopathology diagnosis is indeterminate4 (Bethesda III or IV), Afirma GEC is performed to identify benign nodules. Afirma GEC is not performed when cytopathology is benign or malignant.
  •  If cytopathology identifies suspicious or malignant results, Afirma offers additional genomic tests-Afirma Malignancy Classifiers – to help guide surgical decisions.

All insurance plans are accepted for Afirma testing, including Medicare. A financial assistance program, Afirma Access, is available for patients who need support with out-of-pocket costs.

Please contact your local Afirma representative, Howie Niskar, (249-496-5626), for more details. To learn more, you can also visit

1 Wang CC, et al. A large multicenter correlation study of thyroid nodule cytopathology and histopathology. Thyroid. 2011;21:243-251.
2 Lewis CM, et al. Thyroid fine-needle aspiration biopsy: variability in reporting. Thyroid 2009;19(7):717-723.
3 Alexander E, et al. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med. 2012;367:705-715.

Compliance & Safety, Referral/Sendouts

Warning: Patients being treated with Fulvestrant (Faslodex)

The manufacturer of the Estradiol reagent has reported a cross reactivity between their Estradiol assay and Fulvestrant causing a falsely elevated level of estradiol. Patients being treated with Fulvestrant should have their Estradiol levels monitored with the following test: Estradiol by LCMS.

Questions or inquiries may be direct to Dr. David Alter in the Pathology Department.


Peripheral Blood Smear Reminder

As of January 12, 2016, pathologist review of peripheral blood smear ordered without accompanying CBC with differential will reflex to adding on a CBC and/or differential in the laboratory. Blood specimens that do not have a slide prepared need to be less than 6 hours old for a pathologist review to be added on.

This is due to the fact that older blood does not smear well and morphology is compromised, especially red cell morphology. This allows for a complete documentation of the patient’s CBC and differential findings in the electronic medical record and standardizes our process among the regional hospitals.

Any questions concerning Peripheral Blood Smear reflexes should be directed to Dr. Jennifer Stumph, Director of Hematology.

Hematology, Test Utilization

Pathologist Review – Reason for Review

Pathologist review of peripheral blood smear (#8367) will have an additional required field to complete upon ordering. We are striving to improve our test utilization, inter-provider communication, and accurate and timely result reporting. Providers will see a choice of the top 10 to 15 reasons for review, including such reasons as “anemia evaluation” and “look for blasts”. An option for “other, see comment” is available for any free text comments to the pathologist.

This change is anticipated to begin for all electronic ordering of this test on February 4, 2016

Any questions concerning these changes may be directed to Dr. Jennifer Stumph, Director of Hematology.

Advanced Technology Laboratory, Compliance & Safety, Cytogenetics, Flow Cytometry, General Information, Molecular Diagnostics, Referral/Sendouts

Informed Consent Requirement

A1AT Proteotype S/Z and Alpha Globin Gene Analysis genetic tests now require informed consent along with those genetic tests that already require it (see below).

Spectrum Health Information Services has added an Ask at Order Entry question (AOE) “Has signed informed consent been obtained from the patient: Yes/No” to these tests. If the answer to this question is no, testing will either not be drawn (outpatient) or cancelled until informed consent is obtained by the ordering provider. Link to Informed Consent Form.

Tests which require informed consent:

A1AT Proteotype S/Z FISH for Trisomy 21
Alpha Globin Gene Analysis FISH for Turner
Alpha1AT Defic Profile FISH for Williams
Angelman/Prader Willi (15q11-q13) by FISH FISH for Wolf-hirschhorn
Angelman/Prader Willi mPCR FISH for XX and XY
CF Carrier Screening by Sequenom FISHAneuTCPanel
CF Gene Sequencing to MAYO FISHDiGeorge
Chromosomal Microarray (CGH) FISHDownSyn
Chromosome Analysis Constitutional FISHMillerDieke
Chromosome Analysis POC FISHPraderWilli
Chromosome Analysis Prenatal FISHSmithMageni
Factor V Leiden DNA Analysis FISHSubtelomeres
FISH for aneuVysion FISHWilliams
FISH for Common trisomies in POC FISHWolf
FISH for Down syndrome Hemochromatosis DNA
FISH for Major trisomies Huntington’s Disease Molecular Analysis
FISH for Miller-dieker MTHFR C677T
FISH for Prader-willi Prothrombin G20210A
FISH for Smith-Magenis Send Out CMA
FISH for Subtelomeres