Comparative Evaluation of Two NGAL Automated Immunoassays in Urine and Plasma.

BACKGROUND: Acute kidney injury (AKI), a frequent and serious complication of hospitalized patients, is associated with increased mortality and morbidity. Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker for the early identification of AKI. We report a comparative laboratory verification of the Abbott Diagnostics (ARCHITECT® urine NGAL) and BioPorto Diagnostics (NGAL TestTM) assays including an assessment of the Abbott assay's performance in EDTA plasma. METHODS: Intra-/interbatch imprecision, linearity, recovery, and limit of quantitation (LoQ) were assessed and an interassay comparison performed (n = 51). Between-laboratory agreement was assessed against other laboratories using the Abbott (n = 48) and BioPorto (n = 94) assays. Plasma NGAL (pNGAL) levels were measured in non-AKI patients with a range of estimated glomerular filtration rates (n = 80). RESULTS: Coefficients of variation (CVs) for intra- and interbatch imprecision were 0.7%-12.4% and 1.9%-27.5% for the BioPorto assay, respectively, and 1.4%-6.3%/3.4%-6.8%, respectively, for the Abbott assay. The BioPorto assay exhibited a higher LoQ (27.5 ng/mL vs 1.2 ng/mL). Both assays were linear over the range 5-6000 ng/mL. Recovery of recombinant NGAL was 113.1 ± 7.1% and 96.5 ± 7.8% for the Abbott and BioPorto assays, respectively. On average, the Abbott assay gave results 9.2% lower than the BioPorto assay. Mean differences of 0.2% (Abbott) and 20.2% (BioPorto) were observed in the between-laboratory comparison. In patients without AKI, pNGAL levels were inversely proportional to eGFR. CONCLUSIONS: Performance of the Abbott and BioPorto assays was similar although the latter performed less well at lower NGAL concentrations. The Abbott assay tended to yield lower results, exhibited a lower LoQ and over-recovered NGAL. Although only Conformité Européenne-marked and marketed for use in urine, the Abbott assay demonstrated equivalent performance to the BioPorto assay with EDTA plasma.

kEDTA Sample Contamination: A Reappraisal.

BACKGROUND: Potassium EDTA (kEDTA) contamination of serum samples is common, causing spurious hyperkalemia, hypozincemia, and hypocalcemia that if unrecognized may adversely affect patient care. Gross kEDTA contamination is easy to detect, but identification of spurious electrolytes due to small amounts of contamination requires measurement of serum EDTA. We validated an EDTA assay on the Abbott Architect and reassessed its value in identifying kEDTA contamination and in studying mechanisms for contamination. METHODS: Within- and between-batch imprecision, linearity, recovery, interference, and carryover were assessed. Serum supplemented with k2EDTA plasma, to mimic sample contamination, was used to study its effect on potassium, calcium, zinc, magnesium, and alkaline phosphatase. Our current laboratory protocol for identification of kEDTA contamination, based on measurement of serum calcium, was compared to that of EDTA measurement. RESULTS: The EDTA assay displayed acceptable performance characteristics. Hemoglobin was a positive interferent. EDTA was detectable in serum contaminated with 1% (v:v) k2EDTA plasma. An increase in serum potassium of 0.54 mmol/L (11.9%) was observed at a measured EDTA concentration of 0.19 mmol/L, equivalent to 3.2% (v:v) contamination. At this EDTA concentration reductions were also observed in zinc (71%), calcium (1%), alkaline phosphatase (ALP) (4%), and magnesium (2.4%). The serum EDTA assay detected contamination in 31/106 patient samples with hyperkalemia (potassium ≥6.0mmol/L), 20 of which were undetected by the current laboratory protocol. CONCLUSIONS: The EDTA assay displayed acceptable performance, with the ability to reliably measure EDTA at low concentrations. Only a small amount of kEDTA causes significant spurious hyperkalemia and is only reliably detected with EDTA measurement.