Ordering Recommendation

Recommended for the evaluation of individuals with suspected primary biliary cholangitis (PBC) who test negative for anti-mitochondrial antibodies (AMA).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to ARUP Standard Transport Tube. (Min: 0.1 mL)

Storage/Transport Temperature

Refrigerated

Unacceptable Conditions

Non-Serum, heat-inactivated, contaminated, grossly icteric, severely lipemic, grossly hemolyzed specimens or inclusion of fibrin clot.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Wed

Reported

1-8 days

Reference Interval

Test Number
Components
Reference Interval
  Anti-sp100 Antibody, IgG 24.9 Units or less

Interpretive Data

SP100 IgG antibodies can be detected in patients with primary biliary cholangitis (PBC) and may be of diagnostic relevance in a subset of patients with PBC who are negative for anti-mitochondrial antibodies (AMA). These antibodies have a relatively low sensitivity with excellent specificity for PBC. A negative result does not rule out PBC.


Component Interpretation
Anti-sp100 Antibody, IgG 20.1 Units or less            Negative
20.1-24.9 Units              Equivocal
25.0 Units or greater       Positive

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

83516

Components

Component Test Code* Component Chart Name LOINC
3002484 Anti-sp100 Antibody, IgG 96560-8
* 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

Anti-sp100 Antibody, IgG