Ordering Recommendation

Aids in diagnosis of innate immunodeficiencies when genetic defects of the innate immune system are suspected in individuals negative for other immunodeficiencies (eg, no detectable abnormality of antibody function, complement activity, neutrophil function, or cell-mediated immunity). This test does not measure the function of toll-like receptor 3 (TLR3). Molecular testing is the preferred method for detection of defects in TLR3. For patients who are lymphopenic, collection of 10 mL of whole blood, rather than the minimum required volumes, is recommended to increase the likelihood that a sufficient number of lymphocytes can be isolated for testing.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Collect control specimen from a healthy individual unrelated to patient at approximately the same time as and under similar conditions to the patient.

Collect

Green (sodium heparin) (patient) AND green (sodium heparin) (control). Also acceptable: Yellow (ACD solution A) (patient) AND yellow (ACD solution A) (control). Patient and control specimens must be collected within 48 hours of test performance.

Specimen Preparation

Transport 10 mL whole blood (patient) AND 10 mL whole blood (control) in original collection tubes. (Min: 7 mL (patient) AND 7 mL (control)) Do not refrigerate or freeze. LIVE CELLS REQUIRED.

Infant Minimum: 3 mL whole blood (patient) AND 7 mL whole blood (control).

For patients who are lymphopenic, collection of 10 mL of whole blood, rather than the minimum required volumes, is recommended to increase the likelihood that a sufficient number of lymphocytes can be isolated for testing.

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE.

Unacceptable Conditions

Yellow (ACD solution B). Refrigerated or frozen specimens.

Remarks
Stability

Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
New York State Clients: Ambient 24 hours; Refrigerated: Unacceptable; Frozen: Unacceptable

Methodology

Cell Culture/Quantitative Multiplex Bead Assay

Performed

Sun, Tue, Wed, Thu, Fri, Sat

Reported

9-10 days

Reference Interval

By report

Interpretive Data

Toll-like receptors (TLR) are tested independently by stimulation with TLR-specific ligands in a peripheral blood mononuclear cell (PBMC) culture. PBMC production of IL-1 beta, IL-6, and TNF alpha is determined by multiplex bead assay for TLR 1,2,4-8.

TLR-specific ligands include Pam3CSK4, a synthetic bacterial lipoprotein (TLR2-TLR1 ligand); zymosan cell wall particles from Saccharomyces cerevisiae (TLR6-TLR2 ligand); lipopolysaccharide (LPS) ultra-pure S. minnesota LPS (TLR4 ligand); flagellin purified from S. typhimurium (TLR5 ligand); and CL097 imidazoquinoline compound (TLR7-TLR8 ligand).

Compliance Category

Laboratory Developed Test (LDT)

Note

Results for TNF alpha, IL-1 beta, and IL-6 are reported as pg/mL. Interpretation comparing the patient results to the simultaneously collected client normal control and the laboratory normal control will be provided by an ARUP medical director.

Limitation: Defects in IRAK-4 and MyD88 result in compromised TLR signaling. Exception is endosomal TLR4, which is IRAK-4 and MyD88 independent.

Hotline History

N/A

CPT Codes

86353 x5; 83520 x2; 83529

Components

Component Test Code* Component Chart Name LOINC
0051589 Toll-Like Receptor Function
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • TLR Function
Toll-Like Receptor Function