Sample to sample carryover: A source of analytical laboratory error and its relevance to integrated clinical chemistry/immunoassay systems

Abstract

Background Integrated systems that combine clinical chemistry and immunoassay analyzers are used routinely. Sample to sample carryover is an inherent risk and can cause erroneously high patient test results for immunoassays. IVD manufacturers and laboratories must be aware of this phenomenon and guard against it. Methods We used a sample carryover protocol that directs the clinical chemistry module to process samples with very high immunoassay analyte concentrations followed by samples with very low concentrations for the same analyte. Low concentration samples were then tested by the immunoassay module to determine if the clinical chemistry module caused primary sample tube to primary sample tube carryover of the immunoassay analyte. Results Sample carryover was assessed on the Abbott ci8200 for HBsAg, AFP, β-hCG, and PSA. Observed HBsAg carryover met the design specification of < 0.1 ppm. Carryover for the other analytes was < 0.1 ppm or below the assay limit of detection. Conclusions IVD manufacturers must design integrated systems to minimize primary specimen tube carryover and avoid analytical laboratory error that can impact patient safety. Carryover testing is difficult for clinical laboratories to perform in order to verify system performance. Laboratories must consider the potential for specimen carryover and its impact on results whether moving primary sample tubes between separate analyzers or using an integrated system.