Validation of the Procalcitonin Assay on the Abbott Architect i1000

Abstract

Background Procalcitonin (PCT) is an emerging biomarker for detecting sepsis. Recently, the US Food and Drug Administration cleared the expanded use of this biomarker for guiding clinicians regarding antibiotic treatment. To our knowledge, there are no published method validations for the Abbott Architect PCT assay. This article will discuss the process of method validation of the B·R·A·H·M·S PCT assay on the Abbott Architect platform. Methods We studied the precision, accuracy, and linearity of the Architect method following the guidance of the Clinical and Laboratory Standards Institute EP5-A2 document. Furthermore, we also tested the impact of major sources of interference from hemolysate, lipoproteins, and bilirubin. To validate the Architect method, we compared patients' serum PCT measurements with our previously established Mini VIDAS (bioMerieux) PCT assay. Results Statistical analysis showed that the 2 assays have good correlation (r > 0.99), slope of 1.023, and intercept of −0.760. The calculated bias is −7.435%. The Architect method showed good precision with %CV < 3.5% for both interassay and intraassay compared with %CV < 6.5% for Mini VIDAS, which was previously determined at our institution. No bias >10% was observed with the Architect method when pooled serum samples were spiked with interferants. The turnaround time for both platforms was the same (20 min); however, in contrast with Mini VIDAS, the Architect system has automated pipetting of samples and can perform multiple assays simultaneously. Conclusion These results showed that the Architect B·R·A·H·M·S PCT assay has analytical characteristics conducive for diagnostic use in clinical laboratories. Our method validation report will be beneficial for other institutions to adapt this assay on existing Abbott Architect i1000 immunoassay analyzers.

New Insights in Laboratory Testing for COVID-19 Patients: Looking for the Role and Predictive Value of Human epididymis secretory protein 4 (HE4) and the Innate Immunity of the Oral Cavity and Respiratory Tract

“…Increase in D-Dimer levels and abnormal D-dimer levels are associated with poor prognosis [34,35]. According to others authors, PCT and platelet count may be potential predictors of disease severity and PCT may be considered a secondary bacterial infection marker [36][37][38].…”

Procalcitonin levels in pregnancy: A systematic review and meta‐analysis of observational studies

“…We also note that the studies included in the present meta‐analysis report different assays to evaluate procalcitonin levels, which is also a limitation. However, we believe this is a minor limitation to our analysis, as studies have demonstrated concordance in procalcitonin levels across assays 41,42 …”

“…However, we believe this is a minor limitation to our analysis, as studies have demonstrated concordance in procalcitonin levels across assays. 41,42 Many studies were rated as good on the AHRQ standard. Several were poor, most commonly due to lack of comparability of cohorts.…”

The Effect of Polypharmacy on Procalcitonin Levels in The Intensive Care Admission of Geriatric Patients with Sepsis

“…For example, it is reported that the interference value determined for trimethoprim can exceed 10% (18). In another study comparing the methods of two different devices, it is stated that there may be high bias values in icteric serum samples ranging from 6.6% to 28.6% (19). This list is constantly expanding with similar new studies.…”

“…The drugs that have been found to typically increase or decrease serum PCT levels are drugs that cause an endogenous rise of cytokines (17,18). Also, it should be kept in mind that lipemic, icteric and hemolysis serums may cause problems such as low or excessive evaluation in laboratory results due to interference (18,19). Recent studies have demonstrated that there is an inverse correlation between vitamin D and PCT, that giving vitamin D to the patients or vitamin D deficiency in patients can significantly alter PCT results (20).…”