Verification of BRAHMS Procalcitonin (PCT) Assay Performance on Two ARCHITECT i2000SR Analyzers Article Swipe

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Valentinas Gruzdys , Kenneth Cahoon , L. Pearson , Christopher M. Lehman ·

YOU? · · 2018 · Open Access · · DOI: https://doi.org/10.1093/ajcp/aqy112.352

Healthy individuals present with PCT levels below 0.1 ng/mL. A rapid rise in PCT occurs during systemic inflammation, particularly secondary to bacterial infection. PCT concentration is a specific and valuable indicator of sepsis risk progression. PCT method verification was performed on two Abbott ARCHITECT i2000SR instruments in this study. Precision was determined from three control levels assayed in duplicate twice a day for 20 days. Linearity was determined by triplicate analysis of pooled patient samples serially diluted with the manufacturer’s recommended diluent to span a PCT range of 0.10 to 100.00 ng/mL. Accuracy was assessed by comparison against the BRAHMS Kryptor assay through analysis of 109 patient samples on each ARCHITECT instrument spanning the analytical measurement range. Deming regression analysis was performed. The limit of blank (LoB) and limit of quantitation (LoQ) were determined. Reference interval (RI) was verified. Freeze-thaw cycles (3), room temperature (48 hours), refrigerated (5 days), and frozen (–20oC, 30 days) stabilities were assessed for both SST and PST samples. The highest observed total standard deviation (SD) was 0.01 ng/mL at 0.20 ng/mL, 0.06 ng/mL at 2.00 ng/mL, and 3.17 ng/mL at 70.00 ng/mL. The assay was linear in the range of 0.10 to 100.00 ng/mL. Deming regression slopes of 0.95 (ARCHITECT A), 0.99 (ARCHITECT B) and intercepts of –0.52 (ARCHITECT A), –0.34 (ARCHITECT B) were calculated from the accuracy data. Out of 109 samples analyzed on ARCHITECT A, the positive predictive value was 95% and 97% at 0.5 and 2.0 ng/mL, respectively. The negative predictive value was 81% and 92% at 0.5 and 2.0 ng/mL, respectively. ARCHITECT B results were comparable. The LoB and LoQ were verified to be 0.00 ng/mL and <0.01 ng/mL, respectively. The RI was verified to be <0.07 ng/mL in both SST and PST samples. Both SST and PST sample types were determined to be within the acceptable limits of stability (<10% difference from original value) after three freeze-thaw cycles, 24 hours at room temperature, 5 days at refrigerated, and 15 days at frozen (–20oC) storage conditions. The method was verified to be sufficiently precise, linear, and sensitive in accordance with the manufacturer’s claims. The manufacturer’s suggested reference interval and specimen stabilities were verified. However, a negative bias at clinically validated cutoffs would result in false-negative results without implementation of a correction factor.

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Detection limit Procalcitonin Chromatography Repeatability Linear regression Mathematics Medicine Chemistry Animal science Sepsis Nuclear medicine Surgery Statistics Biology

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Type: article
Language: en
Landing Page: https://doi.org/10.1093/ajcp/aqy112.352
PDF: https://academic.oup.com/ajcp/article-pdf/150/suppl_1/S149/25805739/aqy112.352.pdf
OA Status: bronze
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DOI: https://doi.org/10.1093/ajcp/aqy112.352

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Title: Verification of BRAHMS Procalcitonin (PCT) Assay Performance on Two ARCHITECT i2000SR Analyzers

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Type: article

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Language: en

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Publication year: 2018

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Publication date: 2018-09-21

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Authors: Valentinas Gruzdys, Kenneth Cahoon, L. Pearson, Christopher M. Lehman

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Landing page: https://doi.org/10.1093/ajcp/aqy112.352

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Concepts: Detection limit, Procalcitonin, Chromatography, Repeatability, Linear regression, Mathematics, Medicine, Chemistry, Animal science, Sepsis, Nuclear medicine, Surgery, Statistics, Biology

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