May 2023: Discontinued – Natural Killer Cells, Functional (NKFUNC)

Immediate Test Change

Test Discontinuation – Natural Killer Cells, Functional (NKFUNC)

Effective May 22, 2023.

Natural Killer Cells, Functional (NKFUNC) testing has been discontinued.

Discontinuation is due to limited availability, logistical limitations, and short specimen stability (less than 23 hours).

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.

May 2023: COVID-19 Testing – CPT Code Update

Immediate Test Change

COVID-19 Testing – CPT Code Update

Effective May 11, 2023.

In accordance with recent guidance provided by the Department of Health and Human Services on May 9, 2023, the CPT code associated with COVID-19 testing will change.

Beginning May 11, 2023, the CPT code is changing as a result of the end of the COVID-19 Public Health Emergency.

The new CPT code will display in the Test Directory starting May 11, 2023.

COVID-19 Testing

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.

April 2023: Updates to H. pylori Urea Breath Test

Immediate Test Change

Updates to H. pylori Urea Breath Test (HPYLBR)

Effective May 2, 2023.

Updated Test

Helicobacter pylori Breath Test (HPYLBR)

Effective May 2, 2023, the Immunopathology Laboratory section of Cleveland Clinic Laboratories will provide a new H. pylori urea breath test.

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.

Changes to Specimen Collection

Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.

Collection Kits

The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.

One box contains five kits. Each kit contains:

  • (1) Blue baseline breath collection bag
  • (1) Grey post-ingestion breath collection bag
  • 75mg 13C-urea tablet
  • 4.3g package of Citrica (citric acid)
  • Straw
  • Drinking cup
  • User guide
  • (4) Labels
  • Sample transport bag
  • Package insert

Test Overview

Test Name

Helicobacter pylori Breath Test

Test Code

CPT Code

83013

Methodology

13C Infrared Spectroscopy

Specimen Type

1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit

Stability

Ambient
14 days

Refrigerated
Unacceptable

Frozen
Unacceptable

Reference Range

Negative

Clinical Information

The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.

Limitations

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.

December 2022: Changes to Acceptable Tube Type for Azole Anti-Fungal Therapeutic Drug Monitoring

Special Communication

December 2022: Changes to Acceptable Specimen Containers for Azole Anti-Fungal Therapeutic Drug Monitoring

Effective December 20, 2022

Plasma collected in Green Lithium Heparin Tubes will no longer be accepted for azole anti-fungal therapeutic drug monitoring tests.

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:

  • Fluconazole (FLUC)
  • Isavuconazole (ISACON)
  • Itraconazole (ITRAC)
  • Posaconazole (POSACN)
  • Voriconazole (VORCON)

Updated Specimen Requirements

Specimen Type:
Serum

Volume:
0.5 mL

Collection Container:
Red (Serum) No Additive Tube

Transport Temperature:
Refrigerated

Do not use gel separator tubes.

August 2022: Changes to C Telopeptide, Beta Cross Linked (CTELO)

Special Communication

August 2022: Changes to C Telopeptide, Beta Cross Linked (CTELO)

Effective September 6, 2022

C Telopeptide, Beta Cross Linked (CTELO)

Changes to Specimen Requirements

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

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.

Changes to Reference Ranges

Male

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

July 2022: Test Delay – Testosterone, Total and Free, Serum (TFTEST)

Immediate Test Change

Test Delay – Testosterone, Total and Free, Serum (TFTEST)

Effective July 18, 2022.

Delayed Test

Testosterone, Total and Free, Serum (TFTEST)

Send-out Testosterone, Total and Free, Serum (TFTEST) testing performed at Mayo Clinic Laboratories is currently delayed for approximately three weeks.

At this time, Mayo Clinic Laboratories does not have an estimate for when turnaround time will return to the expected value of four to six days.

Note:
Specimens are stable for 60 days when frozen.

Alternative Tests

Bioavailable Testosterone, SHBG, Adult Male (BTESTO)

In-house test for total testosterone by immunoassay and calculated bioavailable testosterone for adult males.

Bioavailable Testosterone/SHBG, Female & Child (BTSTFC)

Send-out test for total testosterone by LC-MS/MS and calculated bioavailable/free testosterone for children and adult females.

July 2022: Changes to Sulfonylurea Hypoglycemics (SULFON)

Special Communication

July 2022: Changes to Sulfonylurea Hypoglycemics (SULFON)

Effective July 5, 2022

Sulfonylurea Hypoglycemics (SULFON)

Changes to Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.3 mL

Collection Container:
Red (Serum) No Additive Tube

Transport Temperature:
Frozen

Do not draw serum gel tubes for this test.

Additional Info:
Centrifuge and aliquot ASAP or within 2 hours of collection.

Separate specimens must be submitted when multiple tests are ordered.

Alternative Specimen

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.3 mL

Collection Container:
Grey Hemogard, Sodium Fluoride/Potassium Oxalate Tube

Transport Temperature:
Frozen

Do not draw serum gel tubes for this test.

Additional Info:
Centrifuge and aliquot ASAP or within 2 hours of collection.

Separate specimens must be submitted when multiple tests are ordered.

Changes to Reference Ranges

Refer to Report

  • Rosiglitazone
  • Chlorpropamide
  • Glimepiride
  • Glipizide
  • Pioglitazone
  • Glyburide
  • Nateglinide
  • Repaglinide
  • Tolazamide
  • Tolbutamide

Changes to Test Build

Add:

  • Rosiglitazone
  • Pioglitazone

Remove:

  • Acetohexamide

June 2022: Changes to Testosterone, Total and Free, Serum (TFTEST)

Special Communication

June 2022: Changes to Testosterone, Total and Free, Serum (TFTEST)

Effective June 30, 2022

Testosterone, Total and Free, Serum (TFTEST)

Changes to Specimen Requirements

Specimen Type:
Serum

Volume:
2.5 mL

Minimum Volume:
1 mL

Collection Container:
Red (Serum) No Additive Tube

Transport Temperature:
Refrigerated

Do not draw serum gel tubes for this test.

Changes to Reference Ranges

Male

1 to 8 Years:
<0.13 ng/dL

9 Years:
<0.13 – 0.45 ng/dL

10 Years:
<0.13 – 1.26 ng/dL

11 Years:
<0.13 – 5.52 ng/dL

12 Years:
<0.13 – 9.28 ng/dL

13 Years:
<0.13 – 12.6 ng/dL

Female

1 to 15 Days:
<0.13 – 0.25 ng/dL

16 to 364 Days:
Values decrease gradually from newborn (<0.13 – 0.25 ng/dL) to prepubertal levels.
*Citation: J Clin Endocrinol Metab 1973;36(6):1132-1142.

1 to 4 Years:
<0.13 ng/dL

5 Years:
<0.13 ng/dL

6 Years:
<0.14 ng/dL

7 Years:
<0.13 – 0.23 ng/dL

8 Years:
<0.13 – 0.34 ng/dL

9 Years:
<0.13 – 0.46 ng/dL

10 Years:
<0.13 – 0.59 ng/dL

11 Years:
<0.13 – 0.72 ng/dL

12 Years:
<0.13 – 0.84 ng/dL

13 Years:
<0.13 – 0.96 ng/dL

14 Years:
<0.13 – 1.06 ng/dL

15 to 18 Years:
<0.13 – 1.09 ng/dL

19 Years:
<0.13 – 1.08 ng/dL

20 to 24 Years:
<0.13 – 1.08 ng/dL

25 to 29 Years:
<0.13 – 1.06 ng/dL

30 to 34 Years:
<0.13 – 1.03 ng/dL

35 to 39 Years:
<0.13 – 1.00 ng/dL

40 to 44 Years:
<0.13 – 0.98 ng/dL

45 to 49 Years:
<0.13 – 0.95 ng/dL

50 to 54 Years:
<0.13 – 0.92 ng/dL

55 to 59 Years:
<0.13 – 0.90 ng/dL

60 to 64 Years:
<0.13 – 0.87 ng/dL

65 to 69 Years:
<0.13 – 0.84 ng/dL

70 to 74 Years:
<0.13 – 0.82 ng/dL

75 to 79 Years:
<0.13 – 0.79 ng/dL

80 to 84 Years:
<0.13 – 0.76 ng/dL

85 to 89 Years:
<0.13 – 0.73 ng/dL

90 to 94 Years:
<0.13 – 0.71 ng/dL

95 to 100 Years:
<0.13 – 0.68 ng/dL