Category: Special Communication

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

Effective September 6, 2022

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.

Reference Ranges

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)

Specimen Requirements

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.

Reference Ranges

Changes to Reference Ranges

Refer to Report

Rosiglitazone
Chlorpropamide
Glimepiride
Glipizide
Pioglitazone
Glyburide
Nateglinide
Repaglinide
Tolazamide
Tolbutamide

Test Build

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)

Specimen Requirements
Reference Ranges

Specimen Requirements

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.

Reference Ranges

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

May 2022: Immediate Test Discontinuation – Giardia lamblia IgG, IgA, IgM (GIAGAM)

Immediate Test Change

Immediate Test Discontinuation: Giardia lamblia IgG, IgA, IgM (GIAGAM)

Effective May 16, 2022.

Giardia lamblia IgG, IgA, IgM (GIAGAM)

Reason for Discontinuation:

Discontinued by Vendor

Alternative Test:

Cryptosporidium & Giardia Antigens by EIA (OVAPSC)

May 2022: Test Discontinuation – Legionella Testing, LEGMAB & SLEGAB

Special Communication

Test Discontinuation: Digoxin, Free, Serum (DIGFR)

Effective May 2, 2022.

Legionella IgM Abs (LEGMAB)

Legionella pneumophila Antibody (Types 1-6), IgG by IFA (SLEGAB)

Reason for Discontinuation:

Discontinued by Vendor (ARUP)

CDC does not recommend serology: https://www.cdc.gov/legionella/clinicians/diagnostic-testing.html

Alternative Tests:

Legionella culture (LEGCUL)

Legionella Urinary Ag (LEGUAG)

Legionella pneumophila PCR (LEGPCR)

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.

April 2022: Changes to CTELO, MECDS9, and K2 Testing

Special Communication

April 2022: Changes to CTELO, MECDS9, and K2 Testing

All changes effective May 16, 2022.

Changes to Reference Ranges

C Telopeptide, Beta Cross Linked (CTELO)

Male

6 months – 29 years:
238-1019 pg/mL

30-39 years:
225-936 pg/mL

40-49 years:
182-801 pg/mL

50-59 years:
161-737 pg/mL

60-69 years:
132-752 pg/mL

70 years or greater:
118-776 pg/mL

Female

Premenopausal:
136-689 pg/mL

Postmenopausal:
177-1015 pg/mL

Changes to Test Build

Synthetic Cannabinoid Metabolites – Expanded, Urine (Qualitative) (K2)

Change Overview:

9 components have been removed

Components to be Reported:

5-fluoro-PINACA 3-methylbutanoic acid
4-fluoro-BINACA 3,3-dimethylbutanoic acid
5-fluoro-PICA 3,3-dimethylbutanoic acid
5-fluoro-PINACA3,3-dimethylbutanoic acid
MDMB-4en-PINACA butanoic acid
FUBINACA 3-methylbutanoic acid
FUBINACA 3,3-dimethylbutanoic acid
4-carboxy-NA-PIM

Test Discontinuations

Meconium Drug Screen 9 (MECDS9)

Reason for Discontinuation:
Vendor test discontinuation

Alternative Test:
Drug Detection Panel, Meconium, Qualitative (MECDRG) – Available 05/16/22

March 2022: Changes to CBCDIF Result Reporting; Aldosterone Reference Intervals

Special Communication

March 2022: Changes to CBCDIF Result Reporting, Aldosterone Reference Intervals

CBCDIF

Changes to Result Reporting

Complete Blood Count and Differential (CBCDIF)

Effective February 26, 2022.

Updates:

Up to 2% IG will be reported as part of the automated differential.
An absolute IG number will be reported.
Samples with ≥2% IG will continue to have a manual differential performed.
Absolute granulocyte counts (AGCCBC) will have both absolute neutrophil and absolute IG counts reported.
ALC will include both normal and reactive lymphocytes when reactive lymphocytes are present.

Previously:

In samples with <2%, the immature granulocytes (IG)% are added to the neutrophil %.
Samples with ≥2%, IG have a manual differential performed.
Absolute lymphocyte count (ALC) is calculated from the WBC count and % normal (non-reactive) lymphocytes. Reactive lymphocytes are excluded.

Change Overview

The majority of Cleveland Clinic Laboratories’ hematology analyzers are FDA-approved to report “immature granulocytes” (IG), which represent “left-shifted” myeloid precursors that are more mature than blasts (e.g. myelocytes). A small number of IG can be seen in a variety of benign conditions.

The reference range for IG is age-dependent, as listed below; however, normal individuals may occasionally have IG higher than the reference range. Because the hematology analyzers are highly accurate and precise, a staff (pathologist) review is unlikely to add additional information in the setting of a small population of IG.

IG have not been specified in previous reports because of concern for over-interpretation of small numbers of IG. However, reporting IG is in accordance with the analyzer manufacturer’s recommendations, will improve laboratory efficiency, and is becoming the norm among laboratories using these instruments, including in major medical centers.

IG are NOT blasts. Any sample with blasts will have a manual differential performed and a separate blast % will be reported.

Immature Granulocyte Reference Ranges, by patient age (cells/µL):

≤ 2 days:
< 0.29

2 < 14 days:
< 0.28

14 – 30 days:
< 0.23

31 – 90 days:
< 0.10

91 – 180 days:
< 0.07

0.5 – < 2 years:
< 0.15

2 – < 6 years:
< 0.07

6 – < 12 years:
< 0.05

12 – < 18 years:
< 0.04

>/= 18 years:
< 0.01

Reactive lymphocytes have been added to the absolute lymphocyte count (ALC) because they are physiologically active and should be included in this measurement of a patient’s immune function.

Summary of Changes to CBCDIF Reporting:

Name

Updated Reporting

Previous Reporting

CBCDIF with <2.0% Immature Granulocytes (IG)

IG% reported in chart

IG% added to neutrophil%

CBCDIF with >1.9% IG

Manual differential performed

Manual differential performed

CBCDIF with Suspected Blasts

Manual differential performed, blast % reported

Manual differential performed, blast % reported

Absolute Lymphocyte Count (ALC)

ALC = WBC x (lymphocyte % + reactive lymphocyte %)

ALC = WBC x lymphocyte %

ALDO

Changes to Reference Intervals and Interpretative Comments

Aldosterone (ALDO)

Effective February 28, 2022.

The upright reference interval for adults has been updated to < 35.4 ng/dL (from 3.1 – 35.4 ng/dL).

The following interpretative comment will be appended to the results:

The reference interval for plasma/serum aldosterone is based on a normal sodium intake and upright position. High sodium intake may suppress aldosterone, and low sodium intake may increase aldosterone. The supine reference interval is <23.7 ng/dL.

A ratio of aldosterone in ng/mL to direct renin in pg/mL greater than or equal to 3.8 is a positive screening test result for primary aldosteronism when aldosterone is greater than or equal to 15 ng/dL.

RENIND

Changes to Reference Intervals and Interpretative Comments

Direct Renin (RENIND)

Effective February 28, 2022.

The supine reference intervals will display next to the results as:

< 41 years:
4.2 – 52.2 pg/mL

41 – 99 years:
3.6 – 81.6 pg/mL

The following interpretative comment will be appended to the results:

The reference interval for direct renin is based on an upright position. The supine reference intervals are:

< 41 years:
3.2 – 33.2 pg/mL

> 41 years:
2.5 – 45.1 pg/mL

ALDREN

Changes to Reference Intervals and Interpretative Comments

Aldosterone/Direct Renin Ratio (ALDREN)

Effective February 28, 2022.

The reference interval will be updated to <3.8 (from < 4.0).

The following interpretative comment will be appended to the results: