October 2024: Stool Testing Universal Laboratory (STUL) Kit for Microbiology

Stool Testing Universal Laboratory (STUL) Kit for Microbiology

Effective October 1, 2024.

The Stool Testing Universal Laboratory (STUL) Kit for Microbiology contains the collection and transport items necessary for most stool testing.

Place all (3) vials into the white STUL Kit bag or a large biohazard bag with Beaker labels attached externally.

All vials remain at Main Campus for add-on testing, stability permitting. Refer to the Microbiology Collection & Transport Guide: Stool Collection Devices for specific test and item information.

Order STUL Kits

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September 2024: Test Update – Vasoactive Intestinal Polypeptide (VIP), Plasma

Test Update – Vasoactive Intestinal Polypeptide, Plasma (VIP)

Effective October 8, 2024.

Beginning October 8, 2024, Vasoactive Intestinal Polypeptide, Plasma (VIP) will return to the previous reference lab following the resolution of the reagent shortage.

Refer to the table below for an outline of testing changes.

Please contact Client Services with any questions or for assistance.

Test Change Overview

Vasoactive Intestinal Polypeptide, Plasma (VIP)

For specimens collected between 9/17/24 and 10/8/24, the VIP order will be canceled and replaced by a MISC1 test due to the test at Mayo being discontinued as of 9/17/24 with no advance notice. The specimen will be sent to ARUP and results will be uploaded as a PDF when they are received.

New Test

Old Test

Performing Laboratory

ARUP

Mayo Clinic Laboratories

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Enzyme-linked immunosorbent assay (ELISA)

Specimen Collection

Plasma, 2 mL

Lavender K₂EDTA tube

Plasma, 1 mL

Lavender K₂EDTA tube

Minimum Volume

0.5 mL

0.5 mL

Transport Temperature

Critical frozen

Critical frozen

Reference Interval

0-89.1 pg/mL

0-36 pg/mL

Turnaround Time

4-8 days

6-10 days

Vendor Test Information

Test ID: 3018202

TEST ID : FVIP2

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Sept 2024: Immediate Test Change – Testosterone, Free and Total

Immediate Test Change

Test Update – Testosterone, Free and Total (TFTEST)

Effective September 12, 2024.

Beginning September 12, 2024, Testosterone, Free and Total (TFTEST) will be sent to a different reference laboratory due to an emergency inactivation at the current reference laboratory because of reagent problems.

This follows an extended test delay since April of this year.

Please contact Client Services with any questions or for assistance.

For specimens ordered and collected before September 12, 2024, but not received by Mayo before September 12, 2024, Mayo will send them to LabCorp for testing. When available, those results will be uploaded as scanned documents to the lab order.

Test Change Overview

Testosterone, Free and Total (TFTEST)

As part of this change, the test’s name has been modified to clarify its contents and how it is performed. Test name changes for the other testosterone assays are planned for later this fall.

New Test

Old Test

Test Name

Testosterone, free and total, by equilibrium ultrafiltration mass spectrometry

Testosterone, Free and Total

Performing Laboratory

LabCorp

Mayo Clinic Laboratories

Methodology

Equilibrium ultrafiltration; Liquid chromatography/tandem mass spectrometry

Equilibrium dialysis; Liquid chromatography/tandem mass spectrometry

Specimen Collection

Serum, 2.2 mL

Red (No Additive) Tube

Serum, 2.5 mL

Red (No Additive) Tube

Minimum Volume

1.8 mL

1 mL

Transport Temperature

Ambient

Refrigerated

Turnaround Time

5-7 days

4-8 days (delay as of April 19, 2024)

Vendor Test Information

TEST: 070038

Test ID: TGRP

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June 2024: Test Update – Vasoactive Intestinal Polypeptide (VIP), Plasma

Immediate Test Change

Test Update – Vasoactive Intestinal Polypeptide, Plasma (VIP)

Effective June 27, 2024.

Beginning June 27, 2024, Vasoactive Intestinal Polypeptide, Plasma (VIP) will be sent to a different reference laboratory due to issues with the current reagent manufacturer.

Refer to the table below for an outline of testing changes.

Please contact Client Services with any questions or for assistance.

Test Change Overview

Vasoactive Intestinal Polypeptide, Plasma (VIP)

Additional patient preparation information for the new test:
Patients must fast for 10-12 hours and avoid antacid medications or medications that affect intestinal motility for at least 48 hours before collection.

New Test

Old Test

Performing Laboratory

Mayo Clinic Laboratories

ARUP

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Radioimmunoassay (RIA)

Specimen Collection

Plasma, 1 mL

Lavender K₂EDTA tube

Plasma, 1 mL

PPACK tube

Minimum Volume

0.5 mL

0.5 mL

Transport Temperature

Critical frozen

Frozen

Reference Interval

0-36 pg/mL

0-60 pg/mL

Turnaround Time

6-10 days

4-8 days

Vendor Test Information

TEST ID : FVIP2

Test ID: 0099435

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November 2023: Product Discontinuation – BD CultureSwab™

Immediate Test Change

Product Discontinuation: BD CultureSwab™ Liquid Amies Double Swab

Effective November 14, 2023.

Replacements: eSwab™ or Cepheid Collection Device

The eSwab™ (Copan Diagnostics) collection device—utilized by Cleveland Clinic for 8+ years—will now be the primary swab for bacteriology.

No change to the swabbing collection process is needed when using an eSwab™.

Although typically tissue or fluid is a superior quality sample for bacteriology, collecting a swab is often more feasible. The eSwab™ uses a patented flocked swab, which enables the elution of the primary sample into 1 mL of liquid contained within the collection tube. The bacteriology laboratory then uses this liquid for testing.

Swab discontinued by the manufacturer.

Choose the appropriate collection device:

eSwab™

Use for:
Group A Strep PCR GASPCR

Fungal Screen for Candida FUNGSC

Bacteriology cultures:
• Abscess & Wound Culture WCUL
• Anaerobe Culture ANACUL
• Cystic Fibrosis Respiratory Culture CFRCUL
• Ear Culture & Stain EARCSM
• Eye Culture & Stain EYECSM
• MRSA culture screen MRSASC
• MRSA/S. aureus culture screen SANSAL
• Throat Culture THRCUL
• VRE Culture VRESC

Order eSwabs™

Cepheid Collection Device

Use for:
Routine Prenatal Group B PCR GBPCR

S. aureus PCR SAPCR

Order Cepheid Collection Devices

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November 2023: Test Update – Chromogranin A, New Assay

Immediate Test Change

Test Update – Chromogranin A (CHROMA), New Assay

Effective November 9, 2023.

Chromogranin A (CHROMA) will be updated to a new assay effective November 9, 2023.

The results of the current and new tests are not interchangeable. Due to a reagent shortage, the laboratory will not be able to undergo a rebaseline/parallel testing process.

Please contact Client Services for laboratory assistance with interpreting results in patients undergoing serial monitoring.

Test Change Overview

Chromogranin A (CHROMA)

Update?

Details

Methodology

Yes

New Assay:
Immunoassay, BRAHMS CGA II Kryptor Kit

Discontinued:
Cisbio CGA II, ELISA

The results in the new assay are, on average, 20% lower than the previous assay. The bias is more pronounced at concentrations below 200 ng/mL, where the observed bias is 30%.

Test Code

CHROMA

Specimen

Type
Serum

Container
Gold Serum Separator Tube, or
Red Plain (No Additive) Tube

Stability

Yes

Ambient:
48 hours

Refrigerated:
48 hours

Frozen:
3 months

Transport samples frozen.

Days Performed

Yes

Days Performed
Tuesday, Friday

Reported
1-4 days

Reporting

Yes

Reference Interval
<187 ng/mL

The results of the new and old assays will not trend together in the laboratory information system (e.g., Beaker/EPIC).

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November 2023: Test Delay – Oxalate, Plasma and Oxalate, 24-hour Urine

Immediate Test Change

Test Delay – Oxalate, Plasma (OXLATE) and Oxalate, 24-hour Urine (UOXALD)

Effective November 6, 2023.

Oxalate, Plasma (OXLATE) and Oxalate, 24-hour Urine (UOXALD) will be delayed effective November 6, 2023, due to a global reagent shortage.

Currently, there are no alternative testing options available.

The vendor expects the reagent to be available in late November/December 2023.

For Existing Orders/Specimens
Specimens will be stored frozen, pending the arrival of the reagent. However, if specimens exceed validated stability (4 weeks for plasma specimens, 7 days for urine specimens), testing will be canceled.

Questions?
Please contact Client Services for assistance.

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September 2023: Changes to Reference Ranges – Catecholamines, Fractionated, Plasma (PLCAT)

Special Communication

Changes to Reference Ranges – Catecholamines, Fractionated, Plasma (PLCAT)

Effective October 2, 2023.

Catecholamines, Fractionated, Plasma (PLCAT)

Epinephrine (18 years and older)
Seated (15 min): Less than or equal to 330 pmol/L
Supine (30 min): Less than or equal to 265 pmol/L

Norepinephrine (18 years and older)
Seated (15 min): 1050-4800 pmol/L
Supine (30 min): 680-3100 pmol/L

Dopamine (18 years and older)
Seated (15 min): Less than or equal to 240 pmol/L
Supine (30 min): Less than or equal to 240 pmol/L

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August 2023: Test Discontinuation – HIV-1 Western Blot (HIV1CO)

Immediate Test Change

Test Discontinuation – HIV-1 Western Blot (HIV1CO)

Effective August 28, 2023.

HIV-1 Western Blot Antibody Confirmation (HIV1CO) has been discontinued by the performing reference laboratory.

As an alternative, Cleveland Clinic Laboratories recommends HIV-1 p24 Ag + HIV-1-2 Ab, with reflex to differentiation (HIV12C) testing.

This test, which is performed in-house, follows the CDC-recommended screening algorithm of reflex to differentiation.

HIV-1 p24 Ag +HIV-1-2 Ab, with reflex to differentiation (HIV12C)

CPT Code
87389

Performing Laboratory
Cleveland Clinic Laboratories

Methodology
Chemiluminescent microparticle immunoassay (CMIA)

Specimen Type
Serum: Gold Serum Separation Tube
Plasma: Sodium Heparin, Lithium Heparin (Green), or Lavender K₂EDTA Tube

Volume
1 mL

Stability (after separation from cells)
Ambient: 72 hours
Refrigerated: 7 days
Frozen ≤ -20°C: 14 days

Clinical Information
HIV screening and diagnosis

Reference Range
Negative

Additional Information
The screening assay is an antigen-antibody combination; when reactive, an HIV confirmatory assay is automatically added and performed.

The confirmatory assay is FDA-approved and can differentiate HIV-1 from HIV-2, making it an integral part of the testing algorithm.

If a client performs a fourth-generation screen, HIV-1/2 Ab Confirmatory (HIV12M) testing may be ordered following a repeatedly positive screen.

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July 2023: Updates to COMAP, DRGTOF, MECDRG, TAPENU, and UASFR

Special Communication

July 2023: Changes to COMAP, DRGTOF, MECDRG, TAPENU, and UASFR Testing

All changes effective August 21, 2023.

Changes to Specimen Requirements

Complement, Alternate Pathway (AH50), Functional (COMAP)

Specimen Type
Serum

Volume
1 mL

Minimum Volume
0.3 mL

Collection Container
Red Serum (Plain) Tube

Transport Temperature
Frozen, Critical (-70°C)

Specimen Instructions/Other Information
Locations without a -70°C freezer should not collect this test.

Do not use gel separator tubes.

Allow specimen to clot for 1 hour at room temperature. Centrifuge (at refrigerated temperature if possible) and separate serum from cells ASAP or within 2 hours of collection. Transfer into standard aliquot tube and freeze immediately in a -70°C freezer.

Separate specimens must be submitted when multiple tests are ordered.

Unacceptable conditions include specimen types other than serum, specimens left to clot at refrigerated temperature, specimens exposed to repeated freeze/thaw cycles, or specimens that are grossly hemolyzed, lipemic, or icteric.

Changes to Reference Ranges

Complement, Alternate Pathway (AH50), Functional (COMAP)

Reference Range
>= 31 % normal

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Benzoylecgonine
Cutoff 1 ng/g

Cocaine
Cutoff 1 ng/g

Proinsulin, Intact (IPROIN)

18 Years to 99 Years:
<= 7.2 pmol/L

Changes to Test Build

Drug Detection Panel, Meconium, Qualitative (MECDRG)

New Component

Mitragynine (Kratom)
Cutoff 25 ng/g

Tapentadol Quant, Urine (TAPENU)

Remove Components

Tapentadol glucuronide, Urine
Tapentadol-O-sulfate, Urine
N-desmethyltapentadol, Urine

Arsenic, Fractionated Urine (UASFR)

New Component

Arsenic Fractionation Interpretation

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