Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
Citations 6
Assessment of Sigma Error Metrics Associated with Manual Secondary Result Review and Subsequent Artificial Intelligence-Driven Quality Assurance Review—Application to Kidney Stone Analysis
AbstractContextThyroglobulin autoantibodies (TgAbs) affect thyroglobulin immunometric assays (TgIMAs), causing falsely low results. Conversely, heterophilic antibodies (HAs) may cause falsely elevated results. Thyroglobulin (Tg) measurements by mass spectrometry (MS) resist antibody interference. The most effective use of TgIMA/TgMS in the evaluation of Tg remains unclear.ObjectiveThe objective of this work was to study the usefulness of TgMS vs TgIMA in the presence of Tg measurement interference by HA and TgAb.MethodsIn 163 thyroid cancer patients, Tg was postoperatively measured by TgIMA and TgMS. When TgIMA was elevated and TgMS undetectable, HA was assessed by serial dilution and pretreatment with HA blocking reagent. TgIMA and TgMS were compared in TgAb-positive patients with well-characterized clinical status.Results6 out of 45 cases with TgIMA >1 ng/mL had undetectable TgMS. HA interference was confirmed by serial dilution and HA blocking reagent addition. In TgAb-positive cases, TgIMA and TgMS were highly correlated (R2 = 0.86). In patients with structural disease and TgAb, TgIMA and TgMS were detectable in 6/19 patients, and 9/19 cases, respectively. The TgMS concentration range in the 3 discrepant cases ranged from 0.5 to 2.0 ng/mL. Hence, the presence of TgAb was associated with inappropriately reduced Tg concentrations with both TgIMA and TgMS.ConclusionHA cause falsely elevated TgIMA with undetectable TgMS with significant frequency. TgMS can be used to rule out HA interference. Albeit resistant to TgAb in vitro, TgMS detects little Tg in patients with TgAb and structural disease. Hence, TgAb may reduce Tg concentrations in vivo. The implication is that no assay design may be able to overcome this problem. TgMS may not detect structural disease in TgAb-positive patients.
PAPP-A Results Cannot Be Used to Accurately Estimate Gestational Age
Background Gadolinium-based contrast agents (GBCAs) have been used in magnetic resonance imaging for the past 30 years, where they have significantly improved the effectiveness of imaging studies. However, the increased usage of gadolinium in the medical community has also resulted in unexpected interferences in other laboratory assays. This has been particularly the case in clinical elemental analysis using inductively coupled plasma mass spectrometry (ICP-MS). Methods By conducting ICP-MS interference experiments, we describe how gadolinium interferes with elemental analysis by space charge effect, double charge effect and the creation of polyatomic interferences. Additionally, by reviewing more than a year of reference laboratory data from our laboratory information system, we determined the number of elemental tests cancelled due to gadolinium interference. Results Interference experiments show that gadolinium normally found in GBCAs can interfere with heavy metals, platinum and selenium analysis of biological fluids using ICP-MS. Within one year, our institution’s metals laboratory had to cancel 42 selenium serum tests and 19 heavy metal urine panels due to potential interference caused by gadolinium. Conclusions GBCAs will continue to be utilized in hospitals around the world. However, clinical laboratories should be wary of potential interferences caused by GBCAs. Relevant interferences include space charge effect, double charge interference, and the formation of polyatomic interferences caused by gadolinium. These interferences can negatively affect patient care by resulting in cancelled laboratory tests and causing patients to have blood redrawn and analysed at a later date leading to delays in their diagnosis/treatment.