On the Analytic Characteristics of Commercial Acetaminophen Assays in the United States (original) (raw)

The Journal of Applied Laboratory Medicine

Abstract

Background The management of patients with acetaminophen (APAP) toxicity is largely informed by the blood concentration. We sought to assess the analytical characteristics of past and current commercial APAP assays in the United States. Methods We systematically reviewed the analytical characteristics of APAP assays cleared by the Food and Drug Administration’s (FDA) 510(k) premarket notification process by searching the Clinical Laboratory Improvement Amendments (CLIA) database. We collected the following data where available: test principle, precision near 10 mg/L, precision near 150 mg/L, limits of detection, and limits of quantitation. Results For all assays, absolute analytical precision decreased as analyte concentration increased. Near [APAP] = 10 mg/L, the most precise assays had a standard deviation (SD) of 0.2 mg/L or coefficient of variation (CV) of 1% and the least precise assays had a SD of 1.8 mg/L or a CV of 10%. Near [APAP] = 150 mg/L, the most precise assay had a SD...

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