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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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Cleveland Clinic and LabConnect Announce Strategic Alliance

Clinical Update

Cleveland Clinic and LabConnect Announce Strategic Alliance

Collaboration on lab services will accelerate clinical trials to better impact patient care.

Cleveland Clinic Laboratories and LabConnect have announced a strategic alliance to accelerate clinical trials and connect patients to new medicines for improved patient care.

Through this alliance, LabConnect will utilize Cleveland Clinic Laboratories, the reference laboratory within Cleveland Clinic. LabConnect will leverage the health system’s extensive array of testing and assay validation services to support laboratory testing for an increasing number of clinical trials.

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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.

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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.

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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

83013

Methodology

13C Infrared Spectroscopy

Specimen Type

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

Stability

Ambient
14 days

Refrigerated
Unacceptable

Frozen
Unacceptable

Reference Range

Negative

Clinical Information

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

Limitations

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.

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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.

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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.
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February 2022: Immediate Test Discontinuation – Digoxin, Free, Serum (DIGFR)

Immediate Test Change

Immediate Test Discontinuation: Digoxin, Free, Serum (DIGFR)

April 7, 2022: Digoxin, Free, Serum (DIGFR) testing has resumed, and DIGFR ordering has been re-enabled.

For more information, please contact Client Services for assistance.

Digoxin, Free, Serum (DIGFR)

Effective February 28, 2022.

Due to supply issues, Digoxin, Free, Serum (DIGFR) testing is temporarily discontinued effective immediately.

Any new DIGFR orders placed after February 28, 2022 will be canceled.

Cleveland Clinic Laboratories will provide an update when Digoxin, Free, Serum testing is available again.

Alternative Tests:

Digoxin, Unbound, Serum or Plasma (790952) testing is available through LabCorp.

CCL Test Order: Miscellaneous test

  • If a result is required for situations of digoxin toxicity, please order Digoxin, Unbound, Serum or Plasma (790952) from LabCorp as a miscellaneous test.
  • Samples should be collected in a Green Sodium Heparin or Red (Serum) No Additive tube.
  • Transport specimens refrigerated.
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December 2021: Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Immediate Test Change

Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Delayed Test

HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Effective December 14, 2021.

HIV-1 by Western Blot (HIV1CO) testing performed by CCL’s partnered reference laboratory is experiencing extended test delays caused by a nationwide shortage of testing kits.

These delays are anticipated to affect HIV1CO testing until February 2022.

Alternative Test

HIV-1/2 Antibody Confirmatory (HIV12M)

Test name:
HIV-1/2 Ab Confirmatory

Order code:
HIV12M

Specimen type:
Serum

Collection container:
Gold Serum Separation Tube (SST)

Alternative specimen type:
Plasma

Alternative collection container:
Lavender K2EDTA Tube

Transport temperature:
Refrigerated