Limitations

The Atellica IM EPO assay is limited to the detection of EPO in human serum and plasma
(K2-EDTA, lithium heparin, and sodium heparin).

The following information pertains to limitations of the assay:

• The performance of the assay has not been established with cord blood, neonatal
specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than
serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid.

• The performance of the assay has not been established for populations of
immunocompromised or immunosuppressed patients.

• Acetaminophen concentration at 18 mg/dL decreases EPO results by -12.79% at an EPO
concentration of 4-6 mIU/mL. EPO results should not be corrected based on this bias.
Samples above therapeutic levels for acetaminophen should be interpreted with caution.

• Results obtained with the Atellica IM EPO assay may not be used interchangeably with
values obtained with different manufacturers’ assay methods.

• Patients with Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma have
anemia associated with reduced production of erythropoietin because of hyperviscosity,
and elevated levels of interleukin 6.30

• IgG concentration at 6.7 g/dL decreases EPO results by -11.3% at an erythropoietin
concentration of 25–35 mIU/mL. EPO results should not be corrected based on this bias.
Samples with elevated IgG levels should be interpreted with caution.

• Patient samples may contain heterophilic antibodies that could react in immunoassays to
give falsely elevated or depressed results. This assay is designed to minimize interference
from heterophilic antibodies.31,32 Additional information may be required for diagnosis.

• Due to the observed cross-reactivity with common erythropoiesis-stimulating agents
(ESAs), use of the Atellica IM EPO assay in patients undergoing recombinant EPO therapy is
not recommended. Refer to Specificity.