Effective May 22, 2023.
Please do not order Natural Killer Cells, Functional (NKFUNC) testing. If you have an urgent need for testing, please get in touch with Client Services.
Effective May 23, 2023.
Specimen Type
Red Serum Tube (No Additive)
Methodology
Turbidimetric immunoassay
Result Components
Clozapine
Days Performed
Monday – Saturday
Turnaround Time
1-4 days
Clozapine results greater than 1000 ng/mL have been designated as urgent.
Specimen Type
Red Serum Tube (No Additive) or Lavender K2EDTA Tube
Methodology
Liquid chromatography-tandem mass spectrometry
Result Components
Clozapine
Norclozapine
Clozapine-N-Oxide
Days Performed
Sunday – Saturday
Turnaround Time
2-4 days
Effective May 11, 2023.
The new CPT code will display in the Test Directory starting May 11, 2023.
New CPT Code
87635 (previous: U0003)
Additional Information
For more information, please refer to HHS’s Fact Sheet: End of the COVID-19 Public Health Emergency.
Effective May 2, 2023.
This assay design is modeled after the U.S. Centers for Disease Control & Prevention’s assay.1
Specimen Requirements
Lower respiratory samples, including bronchoalveolar lavage (BAL) and sputa, will continue to be the acceptable specimen types for PCR.
Results
Possible interpretations of test results include:
Additional Updates
Beginning May 23, 2023, routine culture for Legionella spp. (LEGCUL) will be discontinued, but culture will reflexively be performed on any sample with detectable Legionella DNA by PCR.
Note: There is no change to Legionella urine antigen (LEGUAG) testing.
Reference
1 Benitez AJ, Winchell JM. Clinical application of a multiplex real-time PCR assay for simultaneous detection of Legionella species, Legionella pneumophila, and Legionella pneumophila serogroup 1. J Clin Microbiol. 2013 Jan;51(1):348-51. doi: 10.1128/JCM.02510-12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3536254/pdf/zjm348.pdf
Effective May 2, 2023.
The qualitative test, based on infrared spectroscopy using 13C, is an aid in diagnosing active infection with Helicobacter pylori and post-treatment monitoring in adult and pediatric patients ages 3-17 years old.
Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.
The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.
One box contains five kits. Each kit contains:
Helicobacter pylori Breath Test
83013
13C Infrared Spectroscopy
1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit
Ambient
14 days
Refrigerated
Unacceptable
Frozen
Unacceptable
Negative
The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.
Despite very high specificity, false positive results may occur due to other gastric organisms, such as H. heilmanni, as well as in patients with hypo- or achlorhydria.
False-negative results may occur in patients who have received antibiotics, proton pump inhibitors, or bismuth preparations.
Clinical correlation is required.
Please collect samples for Azole Anti-Fungal Therapeutic Drug Monitoring tests in Red (serum) No Additive Tubes, centrifuge, and transfer the serum to an aliquot tube.
Tests Affected:
Specimen Type:
Serum
Volume:
0.5 mL
Collection Container:
Red (Serum) No Additive Tube
Transport Temperature:
Refrigerated
Do not use gel separator tubes.
In this video, an expert pulmonary pathologist and director of Cleveland Clinic’s Pulmonary Pathology service briefly covers all lung tumor types – including all the subtypes of lung cancer – listed in the new (2021) World Health Organization classification. Dr. Mukhopadhyay then describes the primary pathologic features of these tumors with high-quality pathology images provided in most cases.
This video should be helpful for patients, surgeons, pulmonologists, oncologists, pathologists, residents, and medical students.
Specimen Type:
Serum
Volume:
1 mL
Minimum Volume:
0.5 mL
Collection Container:
Gold Serum Separation Tube (SST)
Transport Temperature:
Frozen, critical
A morning fasting specimen is preferred.
Separate specimens must be submitted when multiple tests are ordered.
Collection Information:
Allow the tube to sit for 15-20 minutes at room temperature to form a clot. Centrifuge and separate serum from cells ASAP or within 2 hours of collection. Transfer serum to a standard aliquot tube.
Alternative Specimen Type:
Plasma
Volume:
1 mL
Minimum Volume:
0.5 mL
Collection Container:
Lavender K2EDTA Tube
Transport Temperature:
Frozen, critical
Do not draw serum gel tubes for this test.
Collection Information:
Centrifuge and separate plasma from cells ASAP or within 2 hours of collection. Transfer plasma to a standard aliquot tube.
6 Months to 6 Years:
500 – 1700 pg/mL
7 to 9 Years:
522 – 1682 pg/mL
10 to 12 Years:
553 – 2071 pg/mL
13 to 15 Years:
485 – 2468 pg/mL
16 to 17 Years:
276 – 1546 pg/mL
18 to 29 Years:
238 – 1019 pg/mL
30 to 39 Years:
225 – 936 pg/mL
40 to 49 Years:
182 – 801 pg/mL
50 to 59 Years:
161 – 737 pg/mL
60 to 69 Years:
132 – 752 pg/mL
70 to 99 Years:
118 – 776 pg/mL
If there is a clinical concern regarding hyperhomocysteinemia, Cleveland Clinic Laboratories recommends Homocysteine testing (HOMCYS) in place of MTHFR genotyping. Homocysteine testing is less expensive, generates a result more quickly, and provides additional actionable information for patient management.
November 15, 2022: MTHFR genotyping (MTHFRM) will no longer be available as a send-out test, even if ordered as a miscellaneous test.
March 16, 2021: Homocysteine testing (HOMCYS) will replace MTHFR genotyping at Cleveland Clinic.
Test Name
Homocysteine
Test Code
CPT Code
83090
Performing Laboratory
Cleveland Clinic Laboratories
FDA Compliance
In Vitro Diagnostic (IVD)
Methodology
Enzymatic
Days Performed
Sun – Sat
Turnaround Time
8 hours
Specimen Requirements
Type:
Plasma
Volume:
1 mL
Specimen Container:
Light Green Lithium Heparin Plasma Separator Tube (PST)
Transport Temperature:
Refrigerated
Place specimen on ice after draw.
Alternative Specimen Requirements
Type:
Serum
Volume:
1 mL
Specimen Container:
Gold Serum Separation Tube (SST)
Transport Temperature:
Refrigerated
Place specimen on ice after draw.
Special Instructions
• Centrifuge and separate plasma/serum from cells less than one hour after collection.
• If collected in a non-gel separator tube, centrifuge and transfer plasma/serum to a CCL tube and refrigerate.
Stability
Ambient:
4 days
Refrigerated:
4 weeks
Frozen:
10 months
Reference Interval
18-99 Years – Normal:
<15.1 umol/L
If there is a clinical concern regarding hyperhomocysteinemia, Cleveland Clinic Laboratories recommends Homocysteine (HOMCYS) testing.
• Multiple practice guidelines agree that MTHFR polymorphism genotyping should not be ordered as part of a clinical evaluation.
• A cheaper, faster, and more accurate way to test for hyperhomocysteinemia is to measure plasma homocysteine levels.
• If plasma homocysteine levels are high, patients can supplement with vitamins such as B6, B12, folate, and folic acid.
• If plasma homocysteine levels are normal, no treatment is indicated—even if there is an MTHFR variant.
After reviewing these guidelines,
Cleveland Clinic’s RT-PLMI Section of Molecular Pathology, Genomic Medicine Institute, and Laboratory Stewardship Committee agreed to discontinue MTHFR polymorphism genotyping.
The MTHFR gene (OMIM: 607093) on 1p36.22 encodes the 5,10-methylenetetrahydrofolate reductase enzyme, which converts 5,10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, the primary circulatory form of folate. This enzyme is also involved in the metabolism of the amino acid, homocysteine. A deficiency of the enzyme can lead to HHC.
Polymorphisms are common variants within a gene that do not necessarily affect its function, unlike pathogenic or disease-causing variants. Two commonly tested polymorphic variants in MTHFR are:
c.665C>T* (p.Ala222Val)
*Historically referred to as C677T, the ‘thermolabile’ variant
c.1286A>C (p.Glu429Ala)
These variants are so common that approximately 25% of individuals with Hispanic ancestry and 15% of North Americans with European ancestry have two copies of c.665C>T.
The presence of two copies of c.665C>T (homozygosity) may result in decreased MTHFR enzyme activity and mild HHC. Neither of these MTHFR polymorphisms causes severe MTHFR deficiency (<20% enzyme activity).
1. Lack of Evidence for MTHFR Polymorphism Testing. ACMG Practice Guideline. Genet Med. 2013;15(2):153-6.
2. Inherited Thrombophilias in Pregnancy. ACOG Practice Bulletin. No. 197. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018;132:e18–34.
3. Levin BL, Varga E. MTHFR: Addressing Genetic Counseling Dilemmas Using Evidence-Based Literature. J Genet Counsel. 2016;25:901-11.
4. Choosing Wisely® Initiative https://www.choosingwisely.org/
5. Eng, C. A Genetic Test You Don’t Need: Testing MTHFR is usually unnecessary. Cleveland Clinic Health Essentials. https://health.clevelandclinic.org/a-genetic-test-you-dont-need/. Accessed November 19, 2020.
Cleveland Clinic Laboratories encourages providers to incorporate Homocysteine testing (HOMCYS) into their practice in place of MTHFR genotyping.
November 15, 2022: MTHFR genotyping will no longer be available as a send-out test, even if ordered as a miscellaneous test.
March 16, 2021: MTHFR genotyping will no longer be performed in-house at Cleveland Clinic.
