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.

Methodology

Methodology
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)

Age

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

Male

17-61

<188

Not given

72-344

<202

<60

<17

<6

<26

<43

<261

<421

<1001

250-1100

Female

16-44

<25

Not given

<18

<13

<14

<12

<9

<21

<36

<41

<41

<41

2-45

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

Age

0-4 years

5-9 years

10-13 years

14-17 years

18-69 years

70-89 years

>89 years

Male

Not given

<5.4

0.7-52.0

18.0-111.0

35.0-155.0

30.0-135.0

Not given

Female

Not given

0.2-5.0

0.1-7.4

0.5-3.9

0.1-6.4

0.2-3.7

Not given

Specimen Requirements

Specimen Type
Serum

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

Volume
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.

August 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

Special Communication

August 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

All changes effective August 16, 2021.

Changes to Specimen Requirements

Allergen, Food, Alpha-Gal IgE (GALIGE)

Specimen Requirements

Specimen Type:
Serum

Volume:
0.25 mL

Minimum Volume:
0.25 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

Additional Information:
Separate serum from cells ASAP or within 2 hours of collection.

Macroprolactin (MACPRO)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Lavender K2EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

Prolactin, Dilution Study (PROLM)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Lavender K2EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

Changes to Reference Ranges

Allergen, Food, Alpha-Gal IgE (GALIGE)

Less than 0.10:
No significant level detected (Class Score 0)

0.10-0.34:
Clinical relevance undetermined (Class Score 0/1)

0.35-0.70:
Low (Class Score 1)

0.71-3.50:
Moderate (Class Score 2)

3.51-17.50:
High (Class Score 3)

17.51-50.00:
Very high (Class Score 4)

50.01-100.00:
Very high (Class Score 5)

Greater than 100.00:
Very high (Class Score 6)

IBD Serology Disease Panel (IBDSER)

Saccharomyces cerevisiae Antibody, IgA

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

Saccharomyces cerevisiae Antibody, IgG

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

ANCA IFA Titer

Less than 1:20

ANCA IFA Pattern

None detected

Macroprolactin (MACPRO)

Prolactin

Male
2.1-17.7 ng/mL

Female, 1-9 years
2.1-17.7 ng/mL

Female, 10 years and older
2.8-29.2 ng/mL

Monomeric, Prolactin

Male
2.1-13.3 ng/mL

Female, 1-9 years
2.1-13.3 ng/mL

Female, 10 years and older
2.8-19.5 ng/mL

Percent
Greater than 50%

Oxalate (OXLATE)

Normal
< or = 2.0 umol/L

Prolactin, Dilution Study (PROLM)

Prolactin

Male
2.1-17.7 ng/mL

Nonpregnant Female, 1-9 years
2.1-17.7 ng/mL

Nonpregnant Female, 10 years and older
2.8-29.2 ng/mL

Nicotine & Metabolites, Urine (UNICOT)

Nicotine
15 ng/mL

Cotinine (metabolite)
15 ng/mL

3-OH-Cotinine (metabolite)
50 ng/mL

Anabasine (tobacco biomarker)
5 ng/mL

Changes to Test Build

Allergen, Food, Alpha-Gal IgE (GALIGE)

Components Affected

Allergen, Food, Alpha-Gal IgE

Reflex: Allergen Interp, Immunocap Score IgE

IBD Serology Disease Panel (IBDSER)

Components Affected

S. cerevisiae Antibody, IgA

S. cerevisiae Antibody, IgG

Inflammatory Bowel Disease Interp

ANCA IFA Titer

ANCA IFA Pattern

EER Inflammatory Bowel Diseases

Nicotine & Metabolites, Urine (UNICOT)

Components Affected

Remove Nornicotine, Urine

Test Discontinuations

HIV-1 Genotype (HIVGEN)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
HIV 1 Drug Resistance by Next Generation Sequencing (HIVNGS)

Anti-Neut Cyto Ab with Reflex to Titer and MPO/PR3 Ab (NCYTO)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
Neutrophil Cytoplasmic Antibody (ANCA)

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.

July 2021: Test Menu Optimization & Discontinuations – MGLESE, MYSGRV, PARSYN

Special Communication

Test Menu Optimization & Discontinuations: MGLESE, MYSGRV, & PARSYN

Cleveland Clinic regularly updates its clinical practices to align with the latest testing practices as a part of our Continuous Improvement efforts.

A recent review has identified tests that will be discontinued in favor of more simple, focused, and cost-effective testing options.

Please refer to the test information below or contact Client Services for assistance.

Test Discontinuations

Effective August 3, 2021.

Myasthenia Gravis (MG)/Lambert-Eaton Syndrome (LES) Evaluation, Serum (MGLESE)

Alternative Tests:

Acetylcholine Receptor Binding Antibody Test (ACHRAB)*

ACHRAB Clinical Info:
Anti-acetylcholine receptor binding antibody test is used as an aid in the diagnosis of myasthenia gravis. A negative result cannot exclude myasthenia gravis. Clinical correlation is required.

*Note: Acetylcholine Receptor Modulating Antibody (ACEMOD) and Muscle-Specific Kinase Antibody (MUSK) can be ordered separately if clinically indicated.

P/Q-Type Voltage-Gated Calcium Channel (VGCC) Antibody Test (VOLTCA)

VOLTCA Clinical Info:
Aids in the evaluation of muscle weakness in the context of neuromuscular junction disorder with or without cancer, or the diagnosis of paraneoplastic neurological syndromes.

Myasthenia Gravis Evaluation with Muscle-Specific Kinase (MuSK) Reflex, Serum (MYSGRV)

Alternative Tests:

Acetylcholine Receptor Binding Antibody Test (ACHRAB)*

ACHRAB Clinical Info:
Anti-acetylcholine receptor binding antibody test is used as an aid in the diagnosis of myasthenia gravis. A negative result cannot exclude myasthenia gravis. Clinical correlation is required.

*Note: Acetylcholine Receptor Modulating Antibody (ACEMOD) and Muscle-Specific Kinase Antibody (MUSK) can be ordered separately if clinically indicated.

Paraneoplastic Syndrome Ab Panel with Reflex (PARSYN)

Alternative Tests:

Paraneoplastic Autoantibody Evaluation, Serum (PARNEO)

PARNEO Clinical Info:
This supplemental testing is recommended in cases of chorea, vision loss, cranial neuropathy, and myelopathy.

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.

May 2021: National Supply Shortage of Light Blue Coagulation Tubes

Special Communication

Light Blue Coagulation Tubes: National Supply Shortage – Update

There is a severe nationwide shortage of light blue sodium citrate blood collection tubes used for coagulation laboratory tests such as prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and D-dimer.

Currently, no other substitute tube is readily available for coagulation testing.

Given coagulation testing’s critical role in many areas of medicine and surgery, Cleveland Clinic is implementing several supply conservation measures, including:

  • Using a “no additive” tube as a waste tube (instead of a light blue tube) when collecting other blood specimens. 
  • Restricting light blue tubes for use in the ED only for coagulation testing rather than in a routine rainbow draw.

For Ordering Providers:

If a patient is not on anticoagulants or is not going to surgery:

Reconsider the need for routine coagulation testing or consider extending the interval between daily coagulation testing orders. 

If a patient is undergoing treatment with direct oral anti-Xa anticoagulants, such as apixaban or rivaroxaban:

Consider not ordering PT and APTT (they are usually normal in these patients and not helpful in anticoagulant management).  

Due to the severe nationwide shortage, the Robert J. Tomsich Pathology & Laboratory Medicine Institute has updated specimen collection quantity guidelines for 1.8 mL, 2.7 mL, and 3.5 mL light blue sodium citrate coagulation tubes. Refer to the table below for details.

Test Name

Order Code

# of 1.8 mL light blue tubes needed

# of 2.7 mL light blue tubes needed

# of 3.5 mL light blue tubes needed

Platelet Aggregation

12

8

7

Aspirin/Clopidogrel Resistance (Aggregation) Panel

4

3

3

Hypercoagulation Diagnostic Interpretive Panel

5

4

3

Lupus Anticoagulant Diagnostic Interpretive Panel

5

4

3

Platelet Function Screen

4

3

3

PTT Incubated Mixing Study

4

3

3

Cleveland Clinic Laboratories will communicate further updates when available.  Please continue to check our website or contact Client Services at 800.628.6816 for assistance.

April 2021: Changes to AIDYSA, ENCSER, PARNEO, LAMBRT, & MYGRAV Panels

Special Communication

Changes to AIDYSA, ENCSER, PARNEO, LAMBRT, & MYGRAV Panels

Changes to Reference Ranges

Effective May 11, 2021.

These changes will affect interfaced clients.

Autoimmune Dysautonomia Evaluation, Serum (AIDYSA)

Remove:
• (MUSBND) ACh Receptor (Muscle) Binding Ab
• (PARGAD) GAD65 Ab Assay
• (VGKC) Neuronal (V-G) K+ Channel Ab
• N-Type Calcium Channel Ab
• P/Q-Type Calcium Channel Ab
• Striational (Striated Muscle) Ab
• Reflex (MUSMOD) Muscle modulating antibody
• Reflex (CASRFX) CASPR2-IgG CBA
• Reflex (CRMPSX) CRMP-5-IgG
• Reflex (LG1RFX) LGI1-IgG CBA
• Reflex (PURK2X) Purkinje Cell Cytoplasmic Ab Type 2

Add to Panel:
• (CASRFX) CASPR2-IgG CBA
• (CRMPSX) CRMP-5-IgG
• (LG1RFX) LGI1-IgG CBA
• (PURK2X) Purkinje Cell Cytoplasmic Ab Type 2

Autoimmune Encephalopathy Evaluation, Serum (ENCSER)

Remove:
• (GANG3) AChR Ganglionic Neuronal Ab, S
• N-Type Calcium Channel Ab
• P/Q-Type Calcium Channel Ab
• Reflex (MUSMOD) Muscle modulating antibody

Paraneoplastic Autoantibody Evaluation, Serum (PARNEO)

Remove:
• Striational (Striated Muscle) Ab
• N-Type Calcium Channel Ab
• Reflex (MUSMOD) Muscle modulating antibody

Add:
• Reflex (ACMFCS) AChR Modulating Flow Cytometry, S

Test Discontinuations

Effective May 11, 2021.

Myasthenia Gravis/Lambert-Eaton Syndrome (LAMBRT)

Reason:
Discontinued by reference lab (Mayo Clinic Laboratories)

Alternative Test:
Myasthenia Gravis (MG)/Lambert-Eaton Syndrome (LES) Evaluation, Serum (MGLESE)

Myasthenia Gravis Evaluation, Adult (MYGRAV)

Reason:
Discontinued by reference lab (Mayo Clinic Laboratories)

Alternative Test:
Myasthenia Gravis Evaluation with Muscle-Specific Kinase (MuSK) Reflex, Serum (MYSGRV)

Restrictions to PSA and β-HCG, Plasma Add-On Orders

Special Communication

Restrictions to PSA and β-HCG, Plasma Add-On Orders

Due to a potential for falsely-increased results from carryover on analytical laboratory instrumentation, add-on orders for PSA and β-HCG, Plasma are restricted.

Tests affected:

Please refer to the Test Directory for more information.

• PSA (PSA)

• PSA, Free (PSATF)

• PSA, Screening (PSAS1)

• Beta HCG, Quantitative, Blood (HCGQT)

• Beta HCG, Quant Tumor Marker (BHCG)

February 2021: Inhibin B – Changes to Reference Ranges

Special Communication

Inhibin B – Changes to Reference Ranges

Effective February 16, 2021, methodology and reference intervals for Inhibin B (INHIBB) will change.

Test results obtained with the new ANSH Ultra-Sensitive Inhibin B ELISA method and the previous Beckman Coulter Inhibin G Gen II ELISA method cannot be used interchangeably.

Beginning February 16 through May 16, 2021, specimens will be analyzed with both methods to establish a new baseline for individual patient results. Results from the previous method and reference intervals will be posted in a comment on the patient’s chart.

This change increases the detection of inhibin B in all clinically relevant cases and expands the testing range to improve sensitivity.

Additional details are available in the February 2021 Technical Update.

Changes to Reference Ranges

Effective February 16, 2021.

Inhibin B (INHIBB)

Female

1 day – 12 years:
1 – 182 pg/mL

13 – 41 years (regular cycle, follicular phase):
8 – 223 pg/mL

42 – 51 years (regular cycle, follicular phase):
1 – 107 pg/mL

51 – 76 years (postmenopausal):
1 – 11 pg/mL

Male

< 15 days:
68 – 373 pg/mL

15 days – 6 months:
42 – 516 pg/mL

7 months – 7 years:
24 – 300 pg/mL

8 – 30 years:
47 – 383 pg/mL

31 – 72 years:
10 – 357 pg/mL

Methodology

ANSH ultrasensitive Inhibin B ELISA method
formerly Beckman Coulter Inhibin B Gen II ELISA method