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: 


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

Cepheid Collection Device

Use for:
Routine Prenatal Group B PCR GBPCR

S. aureus PCR SAPCR

November 2023: Test Update – Chromogranin A, New Assay

Immediate Test Change

Test Update – Chromogranin A (CHROMA), New Assay

Effective November 9, 2023.

Chromogranin A (CHROMAwill 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)





New Assay:
Immunoassay, BRAHMS CGA II Kryptor Kit


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





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



48 hours

48 hours

3 months

Transport samples frozen.

Days Performed


Days Performed
Tuesday, Friday

1-4 days



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).

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.

Please contact Client Services for assistance.

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

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

Performing Laboratory
Cleveland Clinic Laboratories

Chemiluminescent microparticle immunoassay (CMIA)

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

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

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.

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

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)

Cutoff 1 ng/g

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

May 2023: Discontinued – Natural Killer Cells, Functional (NKFUNC)

Immediate Test Change

Test Discontinuation – Natural Killer Cells, Functional (NKFUNC)

Effective May 22, 2023.

Natural Killer Cells, Functional (NKFUNC) testing has been discontinued.

Discontinuation is due to limited availability, logistical limitations, and short specimen stability (less than 23 hours).

Please do not order Natural Killer Cells, Functional (NKFUNC) testing. If you have an urgent need for testing, please get in touch with Client Services.

May 2023: COVID-19 Testing – CPT Code Update

Immediate Test Change

COVID-19 Testing – CPT Code Update

Effective May 11, 2023.

In accordance with recent guidance provided by the Department of Health and Human Services on May 9, 2023, the CPT code associated with COVID-19 testing will change.

Beginning May 11, 2023, the CPT code is changing as a result of the end of the COVID-19 Public Health Emergency.

The new CPT code will display in the Test Directory starting May 11, 2023.

COVID-19 Testing

New CPT Code
87635 (previous: U0003)

Additional Information
For more information, please refer to HHS’s Fact Sheet: End of the COVID-19 Public Health Emergency.

April 2023: Updates to H. pylori Urea Breath Test

Immediate Test Change

Updates to H. pylori Urea Breath Test (HPYLBR)

Effective May 2, 2023.

Updated Test

Helicobacter pylori Breath Test (HPYLBR)

Effective May 2, 2023, the Immunopathology Laboratory section of Cleveland Clinic Laboratories will provide a new H. pylori urea breath test.

The qualitative test, based on infrared spectroscopy using 13C, is an aid in diagnosing active infection with Helicobacter pylori and post-treatment monitoring in adult and pediatric patients ages 3-17 years old.

Changes to Specimen Collection

Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.

Collection Kits

The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.

One box contains five kits. Each kit contains:

  • (1) Blue baseline breath collection bag
  • (1) Grey post-ingestion breath collection bag
  • 75mg 13C-urea tablet
  • 4.3g package of Citrica (citric acid)
  • Straw
  • Drinking cup
  • User guide
  • (4) Labels
  • Sample transport bag
  • Package insert

Test Overview

Test Name

Helicobacter pylori Breath Test

Test Code

CPT Code



13C Infrared Spectroscopy

Specimen Type

1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit


14 days



Reference Range


Clinical Information

The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.


Despite very high specificity, false positive results may occur due to other gastric organisms, such as H. heilmanni, as well as in patients with hypo- or achlorhydria.

False-negative results may occur in patients who have received antibiotics, proton pump inhibitors, or bismuth preparations.

Clinical correlation is required.