Detection of false results in assays

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

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C435S007100, C435S007930, C436S520000, C436S522000, C436S523000, C436S526000, C436S016000, C436S017000, C436S070000, C436S175000, C436S177000, C424S009200

Reexamination Certificate

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08084223

ABSTRACT:
Methods and reagents are disclosed for detecting a false result in an assay for determining a concentration of an analyte in a whole blood sample suspected of containing the analyte. The method comprises determining by means of the assay a concentration of the analyte utilizing a hemolyzed portion of the blood sample to obtain concentration value 1 and determining by means of the assay a concentration of the analyte utilizing a non-hemolyzed portion of the blood sample and multiplying the concentration times a hematocrit factor to obtain concentration value 2. A ratio of concentration value 1 divided by concentration value 2 is determined and is compared to a predetermined ratio of known reliability. If the ratio is less than the predetermined ratio, a false result is indicated.

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Bouzas et al. Effect of the hematocrit and its correction on the relationship between blood tacrolimus concentrations obtained using the microparticle enzyme immunoassay (MEIA) and enzyme multiplied immunoassay technique (EMIT). Clinical laboratory, (2007) vol. 53, No. 9-12, pp. 591-596.
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