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In-House Interference Testing

• It is recommended that the IVD manufacturer be contacted for information regarding the effect of HBOCs on their instruments.
• If such data are unavailable, a hospital may wish to perform some HBOC interference testing on selected instruments in preparation for processing patient specimens that contain HBOCs. Laboratory interference testing will establish the maximum level of HBOC present at which laboratory analytes can be reported accurately.
• Evaluation of instruments should follow CLSI EP07-A2 guidelines (previously NCCLS). For example, specimens can be prepared containing known analyte concentrations and varying concentrations ranging from zero to 6.5 g/dL HBOC (the maximal expected concentration).
• Analyte concentrations are usually evaluated at two clinically relevant levels based on CLIA '88 and CAP guidelines. OPK Biotech has used CAP guidelines for those analytes which do not have CLIA '88 acceptable recovery guidelines.
• After specimens are analyzed, results from the analyte concentrations plus HBOC are compared to an absolute value (diluted control specimen, without HBOC) to determine the degree of accuracy for the specific analyte with that concentration of HBOC present in the specimen. The HBOC (hemoglobin) concentration at which the instrument is unable to provide an accurate analyte concentration is the minimum HBOC (hemoglobin) concentration at which results would not be reported. All results from specimens containing less than this amount of HBOC may be reported to the attending doctor.
• If a Hospital Laboratory wishes to perform in-house HBOC interference testing, contact OPK Biotech for further information.