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Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine.
J Anal Toxicol. 2017 May 01; 41(4):313-317.JA

Abstract

The Neogen® Fentanyl ready-to-use enzyme-linked immunosorbent assay kit was validated following the Scientific Working Group for Forensic Toxicology Standard Practices for Method Validation in Forensic Toxicology Laboratory Guidelines. Two decision points, 0.5 and 1 ng/mL, were successfully validated for whole blood. For urine, two decision points, 1 and 5 ng/mL, were also successfully validated. The validation included the evaluation of sensitivity, precision, specificity, carryover, plate drift, ruggedness/robustness and a case sample evaluation. The empirically determined limit of detection was 0.25 ng/mL for blood and 0.5 ng/mL for urine. Precision was determined at five different concentrations ranging from 0.25 to 1.5 ng/mL with 15 replicates at each level for whole blood and demonstrated a <2.4% coefficient of variation (CV). In urine, the CV was <5.6% at six different concentrations from 0.5 to 7.5 ng/mL with 15 replicates at each level. Cross-reactivity was evaluated for norfentanyl, acetyl fentanyl, 4-anilino-N-phenethylpiperidine, beta-hydroxythiofentanyl, butyryl fentanyl and furanyl fentanyl.

Authors+Show Affiliations

Toxicology Unit Palm Beach County Sheriff's Office, 3228 Gun Club Road, West Palm Beach, FL 33406, USA.Department of Pathology and Laboratory Medicine, University of Miami Miller School of Medicine, Rosenstiel Medical Science Building (RMSB), 1600 NW 10th Avenue, 7th Floor Suite 7020 (R-5), Miami, FL 33136, USA.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

28119436

Citation

Tiscione, Nicholas B., and Kristin Wegner. "Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine." Journal of Analytical Toxicology, vol. 41, no. 4, 2017, pp. 313-317.
Tiscione NB, Wegner K. Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine. J Anal Toxicol. 2017;41(4):313-317.
Tiscione, N. B., & Wegner, K. (2017). Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine. Journal of Analytical Toxicology, 41(4), 313-317. https://doi.org/10.1093/jat/bkx005
Tiscione NB, Wegner K. Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine. J Anal Toxicol. 2017 May 1;41(4):313-317. PubMed PMID: 28119436.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of the Neogen® Fentanyl ELISA Kit for Blood and Urine. AU - Tiscione,Nicholas B, AU - Wegner,Kristin, PY - 2016/09/27/received PY - 2017/01/06/accepted PY - 2017/1/26/pubmed PY - 2017/7/27/medline PY - 2017/1/26/entrez SP - 313 EP - 317 JF - Journal of analytical toxicology JO - J Anal Toxicol VL - 41 IS - 4 N2 - The Neogen® Fentanyl ready-to-use enzyme-linked immunosorbent assay kit was validated following the Scientific Working Group for Forensic Toxicology Standard Practices for Method Validation in Forensic Toxicology Laboratory Guidelines. Two decision points, 0.5 and 1 ng/mL, were successfully validated for whole blood. For urine, two decision points, 1 and 5 ng/mL, were also successfully validated. The validation included the evaluation of sensitivity, precision, specificity, carryover, plate drift, ruggedness/robustness and a case sample evaluation. The empirically determined limit of detection was 0.25 ng/mL for blood and 0.5 ng/mL for urine. Precision was determined at five different concentrations ranging from 0.25 to 1.5 ng/mL with 15 replicates at each level for whole blood and demonstrated a <2.4% coefficient of variation (CV). In urine, the CV was <5.6% at six different concentrations from 0.5 to 7.5 ng/mL with 15 replicates at each level. Cross-reactivity was evaluated for norfentanyl, acetyl fentanyl, 4-anilino-N-phenethylpiperidine, beta-hydroxythiofentanyl, butyryl fentanyl and furanyl fentanyl. SN - 1945-2403 UR - https://www.unboundmedicine.com/medline/citation/28119436/Validation_of_the_Neogen®_Fentanyl_ELISA_Kit_for_Blood_and_Urine_ L2 - https://academic.oup.com/jat/article-lookup/doi/10.1093/jat/bkx005 DB - PRIME DP - Unbound Medicine ER -