2001784
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Bordetella pertussis Antibodies, IgG and IgM by ELISA with Reflex to Immunoblot

BORDPAN
Example Reports
Negative
Positive

Ordering Recommendation

If serology is used to assess late-stage pertussis, the recommended test is Bordetella pertussis Antibodies, IgA and  IgG by ELISA with Reflex to Immunoblot (2001774). CDC-recommended first-line tests for pertussis are Bordetella pertussis/parapertussis by PCR (0065080) and/or Bordetella pertussis Culture (0060117).

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, or turbid specimens.

Remarks

New York State Clients: There are no NY approved tests available for the IgM component of this assay. NYSDOH will not approve NPL requests for IgM.

Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year
New York State Clients: Ambient: 1 week; Refrigerated: 2 weeks; Frozen: 1 month

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Qualitative Immunoblot

Performed

Tue, Fri

Reported

1-5 days

Reference Interval

Test Number
 Components
 Reference Interval
  B. pertussis Ab, IgG by ELISA 1.04 IV or less
  B. pertussis Ab, IgM by ELISA 1.1 IV or less

Interpretive Data

Recommend that treatment decisions be based on the result of the B. pertussis IgM immunoblot test instead of the ELISA test.  B. pertussis IgM test by ELISA may produce false-positive results.

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.


Component Interpretation
Bordetella pertussis Antibody IgG by ELISA 0.94 IV or less: Negative - No significant level of detectable B. pertussis IgG antibody.
0.95-1.04 IV: Equivocal - Repeat testing in 10-14 days may be helpful.
1.05 IV or greater: Positive - IgG antibody to B. pertussis detected, which may indicate a current or recent exposure/immunization to B. pertussis.
Bordetella pertussis Antibody IgM by ELISA 0.9 IV or less: Negative - No significant level of detectable B. pertussis IgM antibody.
1.0-1.1 IV: Equivocal - Repeat testing in 10-14 days may be helpful.
1.2 IV or greater: Positive - IgM antibody to B. pertussis detected, which may indicate a current or recent exposure/immunization to B. pertussis

Compliance Category

Laboratory Developed Test (LDT)

Note

If Bordetella pertussis Antibody, IgG by ELISA is 1.05 IV or greater, then Bordetella pertussis IgG Immunoblot testing will be added; if Bordetella pertussis Antibody, IgM by ELISA is 1.2 IV or greater, then Bordetella pertussis IgM Immunoblot testing will be added. Additional charges apply.

Hotline History

N/A

CPT Codes

86615 x2; if reflexed, add 86615 for each Immunoblot

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Components

Component Test Code* Component Chart Name LOINC
2001782 B. pertussis Ab, IgG by ELISA 42330-1
2001783 B. pertussis Ab, IgM by ELISA 42329-3
* 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

  • Pertussis Antibody
  • Pertussis IgG, IgM Reflex to immunoblot
Bordetella pertussis Antibodies, IgG and IgM by ELISA with Reflex to Immunoblot