Test Classification and CPT Coding

Test classification: 

This test has been evaluated for the detection of Anaplasma phagocytophilum, Ehrlichia chafeensis, Ehrlichia ewingii, and Ehrlichia canis. 

This assay utilizes ASR’s (analyte specific reagents) and is not FDA cleared.  This test was developed and its performance has been evaluated by the Barnes Jewish Molecular Infectious Disease Laboratory for performance on whole blood specimens.

Assay limit of detection:

500 copies/mL in whole blood for Ehrlichia spp.

250 copies/mL in whole blood for Anaplasma phagocytophilum.

Limitations:

-The detection of target nucleic acid is dependent upon proper sample collection, transport, handling and storage. Failure to observe proper procedures in any one of these steps can lead to incorrect results.

-False-negative results may occur if the target nucleic acid is present at a level that is below the analytical sensitivity of the assay or if there are genomic mutations, insertions, deletions, or rearrangements or if performed very early in the course of illness.

CPT Code:

87798 x 2