Ordering Recommendation

Assist 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.




Cell Culture/Quantitative Multiplex Bead Assay


Sun, Tue, Wed, Thu, Fri, Sat


9-10 days

New York DOH Approval Status

This test is New York DOH 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.


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).

Storage/Transport Temperature


Unacceptable Conditions

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


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

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).

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)


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


CPT Codes

86353 x5; 83520 x2; 83529


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.


  • TLR Function
Toll-Like Receptor Function