Special Communication
Send-out Test Discontinuation – T3 Uptake (T3U)
Effective February 21, 2022.
Category: Special Communication
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
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