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.

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.

Test Delay: Alpha 1 Antitrypsin Phenotype (A1APHE)

Immediate Test Change

Test Delay: Alpha 1 Antitrypsin Phenotype (A1APHE)

Effective April 14, 2022.

Alpha 1 Antitrypsin Phenotype (A1APHE)

The kit manufacturer for Alpha-1-Antitrypsin Phenotype (A1APHE) testing has notified Cleveland Clinic’s designated performing reference laboratory (ARUP Laboratories) that a raw material used to produce test kits is on backorder globally.

Specimens submitted for A1APHE testing will be stored frozen while reagents are unavailable; stability is three months.

ARUP Laboratories anticipates testing to resume in late May and will complete the backlog of specimens as soon as possible.

Alternative Test:

Alpha-1-Antitrypsin Serum testing (AAT)

  • If an alpha-1-antitrypsin protein concentration result is required, please order Alpha-1-Antitrypsin Serum testing (AAT).
  • Testing is performed by Cleveland Clinic Laboratories.
  • Collect plasma in a Light Green Lithium Heparin PST or serum in a Gold SST.
  • Transport specimens refrigerated.

February 2022: Immediate Test Discontinuation – Digoxin, Free, Serum (DIGFR)

Immediate Test Change

Immediate Test Discontinuation: Digoxin, Free, Serum (DIGFR)

April 7, 2022: Digoxin, Free, Serum (DIGFR) testing has resumed, and DIGFR ordering has been re-enabled.

For more information, please contact Client Services for assistance.

Digoxin, Free, Serum (DIGFR)

Effective February 28, 2022.

Due to supply issues, Digoxin, Free, Serum (DIGFR) testing is temporarily discontinued effective immediately.

Any new DIGFR orders placed after February 28, 2022 will be canceled.

Cleveland Clinic Laboratories will provide an update when Digoxin, Free, Serum testing is available again.

Alternative Tests:

Digoxin, Unbound, Serum or Plasma (790952) testing is available through LabCorp.

CCL Test Order: Miscellaneous test

  • If a result is required for situations of digoxin toxicity, please order Digoxin, Unbound, Serum or Plasma (790952) from LabCorp as a miscellaneous test.
  • Samples should be collected in a Green Sodium Heparin or Red (Serum) No Additive tube.
  • Transport specimens refrigerated.

December 2021: Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Immediate Test Change

Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Delayed Test

HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Effective December 14, 2021.

HIV-1 by Western Blot (HIV1CO) testing performed by CCL’s partnered reference laboratory is experiencing extended test delays caused by a nationwide shortage of testing kits.

These delays are anticipated to affect HIV1CO testing until February 2022.

Alternative Test

HIV-1/2 Antibody Confirmatory (HIV12M)

Test name:
HIV-1/2 Ab Confirmatory

Order code:

Specimen type:

Collection container:
Gold Serum Separation Tube (SST)

Alternative specimen type:

Alternative collection container:
Lavender K2EDTA Tube

Transport temperature:

October 2021: TFTEST – Temporary Change in Performing Send-out Laboratory

Immediate Test Change

TFTEST – Temporary Change in Performing Send-out Laboratory

November 4, 2021 – Update: Testosterone, Total and Free, Serum (TFTEST) has resumed being performed by Mayo Clinic Laboratories, the test’s original standard reference laboratory.

This change occurs automatically for TFTEST samples received by Mayo Clinic. Samples received prior to November 4, 2021, will be resulted from the temporary reference laboratory, Quest Diagnostics.

Refer to the details provided below for further information.

Testosterone, Total and Free, Serum (TFTEST) – Temporary Changes

Effective October 25, 2021.

Original Communication:

Beginning October 25, 2021, Testosterone, Total and Free, Serum (TFTEST) will be temporarily sent to an alternate reference laboratory (Quest Diagnostics).

This will occur automatically for new TFTEST samples received by Cleveland Clinic Laboratories.


The assays performed by both reference laboratories employ the same method, but there will be two main changes to the results:

1. Units of reporting for free testosterone will change from ng/dL to pg/mL.

Conversion factors:

  • Testosterone, free (ng/dL) x 10 = Testosterone, free (pg/mL)
  • Testosterone, free (pg/mL) / 10 = Testosterone, free (ng/dL)

2. Reference intervals for both free and total testosterone will be different.

Quest Diagnostics: Reference Intervals for Testosterone, Total (ng/dL)


0-1 day

1-10 days

11-30 days

31 days – 2 months

3-4 months

5-6 months

7-11 months

12 months – 5 years

6-7 years

8-10 years

11 years

12-13 years

14-17 years

> 17 years




Not given















Not given












Quest Diagnostics: Reference Intervals for Testosterone, Free (pg/mL)


0-4 years

5-9 years

10-13 years

14-17 years

18-69 years

70-89 years

>89 years


Not given






Not given


Not given






Not given

Specimen Requirements

Specimen Type

Collection Container
Red BD Hemogard™ Serum Tube (No Additive)

1.8 mL

Minimum Volume
0.9 mL

Do not draw serum gel tubes for this test.

Turnaround Time

Turnaround Time
Turnaround time for samples sent to the temporary performing laboratory (Quest Diagnostics) is estimated at 10 to 14 days.

TFTEST samples collected prior to October 25 will be resulted from the current reference laboratory (Mayo Medical Laboratories) but will have a delayed turnaround time of approximately 14 days.

July 2021: Immediate Test Discontinuation – Hepatitis A Antibody, Total (AHAVT)

Immediate Test Change

Immediate Test Discontinuation: Hepatitis A Antibody, Total (AHAVT)

Test Discontinuations

Hepatitis A Antibody, Total (AHAVT)

Effective July 1, 2021.

Due to vendor reagent being on backorder, Hepatitis A Antibody, Total (AHAVT)’s initially scheduled discontinuation on August 7 has been expedited to July 1, 2021.

Alternative Tests:

Hepatitis A Antibody, IgG (AHAVG)

AHAVG Clinical Info:
Determines immune status to Hepatitis A Virus (HAV) as a result of vaccination or past infection. Should a recent infection be suspected, this test needs to be ordered with AHAVM.

Hepatitis A Antibody, IgM (AHAVM)

AHAVM Clinical Info:
Assesses acute or recent HAV infection. Note: Methodology not approved for donor testing.

COVID-19: Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Special Communication

Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Due to supply constraints related to COVID-19, supplies for Enteric Bacterial Panel by PCR (STLPCR) testing are in extremely limited supply.

While supplies are constrained, culture and antigen testing will be used in place of PCR testing to interrogate specimens for the same pathogens as STLPCR: Campylobacter, Salmonella, Shigella, and Shiga toxin-producing E. coli (STEC/EHEC).

Cleveland Clinic Laboratories will temporarily cancel and credit any STLPCR test requests, then substitute clinically-equivalent culture and antigen testing.

The associated CPT codes for these substitutions are:

• 87449 (x 2)
• 87045

March 2019: Changes to PR1433, GM1BM, OMEGAC

Immediate Test Changes

Changes to 14-3-3 Protein, CSF (PR1433), Ganglioside Antibody Panel (GM1BM), and OmegaCheck (OMEGAC)

14-3-3 Protein, CSF (PR1433)

Effective March 22, 2019.

Effective immediately, 14-3-3 Protein, CSF (PR1433) is discontinued with no recommended replacement.

The performing laboratory is evaluating new reagents; if these are found to be acceptable, this test may be reactivated in the future.

Ganglioside Antibody Panel (GM1BM)

Effective April 18, 2019.

Ganglioside Antibody Panel (GM1BM) will be discontinued on April 18, 2019.

We suggest ordering Ganglioside Antibodies (GANGAB).

OmegaCheck (OMEGA)

Effective April 22, 2019.

Changes to Reference Ranges

> 5.4% by wt

Arachidonic Acid/EPA Ratio:
3.7 – 40.7

Omega-6/3 Ratio:
3.7 – 14.4

0.2 – 2.3% by wt

0.8 – 1.8% by wt

1.4 – 5.1% by wt

Arachidonic Acid:
8.6 – 15.6% by wt

Linoleic Acid:
18.6 – 29.5% by wt

Any additional information will be included in a future Technical Update.  If you have any questions about these changes, please contact Client Services for assistance.