Primary Biliary Cholangitis Panel
Ordering Recommendation
Recommended autoantibody panel for the evaluation of individuals with suspected primary biliary cholangitis (PBC).
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody
Performed
Sun-Sat
Reported
1-8 days
New York DOH Approval Status
Specimen Required
Serum Separator Tube (SST).
Separate from cells ASAP or within 2 hours of collection. Transfer 1.2 mL serum to an ARUP Standard Transport Tube. (Min: 0.8 mL)
Refrigerated.
Non-serum, heat-inactivated, contaminated, grossly icteric, severely lipemic, grossly hemolyzed specimens or inclusion of fibrin clot.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month
Reference Interval
Test Number |
Components |
Reference Interval |
---|---|---|
Mitochondrial (M2) Antibody, IgG | 24.9 Units or less | |
Antinuclear Antibody (ANA), HEp-2, IgG | Less than 1:80 | |
Anti-gp210 Antibody, IgG | 24.9 Units or less | |
Anti-sp100 Antibody, IgG | 24.9 Units or less |
Interpretive Data
Component |
Interpretation |
---|---|
Mitochondrial M2 Antibody, IgG (ELISA) | 20.0 Units or less Negative 20.1-24.9 Units Equivocal 25.0 Units or greater Positive |
Anti-sp100 Antibody, IgG | 20.0 Units or less Negative 20.1-24.9 Units Equivocal 25.0 Units or greater Positive |
Anti-gp210 Antibody, IgG | 20.0 Units or less Negative 20.1-24.9 Units Equivocal 25.0 Units or greater Positive |
FDA
Note
ANA identified by indirect fluorescence assay (IFA) using HEp-2 substrate and IgG-specific conjugate at a screening dilution of 1:80. Positive nuclear patterns reported include homogeneous, speckled, centromere, nucleolar, or nuclear dots. Positive cytoplasmic patterns reported include reticular/AMA, discrete/GW body-like, polar/golgi-like, rods and rings, or cytoplasmic speckled patterns. All positive results are reported with endpoint titers at no additional charge.
Hotline History
Hotline History
CPT Codes
83516 x2; 86381; 86039
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0050065 | Mitochondrial (M2) Antibody, IgG | 14251-3 |
3000090 | Antinuclear Antibody (ANA), HEp-2, IgG | 21424-7 |
3000096 | ANA Interpretive Comment | 49311-4 |
3002483 | Anti-gp210 Antibody, IgG | 96560-8 |
3002484 | Anti-sp100 Antibody, IgG | 96560-8 |