3002480
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Primary Biliary Cholangitis Panel

BILIARY CH
Example Reports
Negative
Positive

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

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 1.2 mL serum to an ARUP Standard Transport Tube. (Min: 0.8 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
  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

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

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
02/21/2023
X
N/A

CPT Codes

83516 x2; 86381; 86039

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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
* 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