Ordering Recommendation

Recommended autoantibody panel for the evaluation of individuals with suspected primary biliary cholangitis (PBC).

Mnemonic
BILIARY CH
Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody

Performed

Sun-Sat

Reported

1-8 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 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

Reference Interval
Test Number
Components
Reference Interval
0050065 Mitochondrial M2 Antibody, IgG (ELISA)
20.0 Units or less Negative
20.1-24.9 Units Equivocal
25.0 Units or greater Positive

3000082 Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFA Less than 1:80
3002478 Anti-sp100 Antibody, IgG
20.0 Units or less Negative
20.1-24.9 Units Equivocal
25.0 Units or greater Positive

3002477 Anti-gp210 Antibody, IgG
20.0 Units or less Negative
20.1-24.9 Units Equivocal
25.0 Units or greater Positive

Interpretive Data

Refer to report.

Compliance Category

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
N/A
CPT Codes

83516 x3, 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
3002484 Anti-sp100 Antibody, IgG
* 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
Primary Biliary Cholangitis Panel