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.

Test Name

Helicobacter pylori Breath Test

Test Code

HPYLBR

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.

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.

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.

Giardia lamblia IgG, IgA, IgM (GIAGAM)

Reason for Discontinuation:

Discontinued by Vendor

Alternative Test:

Cryptosporidium & Giardia Antigens by EIA (OVAPSC)

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.

Digoxin, Free, Serum (DIGFR)

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.

Delayed Test

HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

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

Hepatitis A Antibody, Total (AHAVT)

Due to vendor reagent being on backorder, Hepatitis A Antibody, Total (AHAVT)’s initially scheduled discontinuation on August 7 has been expedited to July 1, 2021.

Alternative Tests:

Hepatitis A Antibody, IgG (AHAVG)

AHAVG Clinical Info:
Determines immune status to Hepatitis A Virus (HAV) as a result of vaccination or past infection. Should a recent infection be suspected, this test needs to be ordered with AHAVM.

Hepatitis A Antibody, IgM (AHAVM)

AHAVM Clinical Info:
Assesses acute or recent HAV infection. Note: Methodology not approved for donor testing.

Complement Factor B (C3PA)

At this time, there is no recommended replacement test.