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Enzyme immunoassay validation for the detection of buprenorphine in urine.
J Anal Toxicol. 2003 Mar; 27(2):103-5.JA

Abstract

A solid-phase enzyme immunoassay involving microtiter plates was proposed by Microgenics to screen buprenorphine in urine. The intra-assay precision at 10 ng/mL was 7.7% (coefficient of variation). The immunoassay was determined to have no cross-reactivity with codeine, dihydrocodeine, morphine, ethylmorphine, 6-monoacetylmorphine, methadone, pholcodine, propoxyphene, dextromoramide, and dextromethorphan at 1 and 10 mg/L. A low cross-reactivity (3% at 1 ng/mL) was observed at low concentrations of norbuprenorphine. After comparing this new immunological test (Singlestep ELISA) for 76 urine specimens with our validated high-performance liquid chromatography-electrospray mass spectrometry (HPLC-ES-MS) procedure, an optimum cutoff concentration of 2 ng/mL was determined for the kit. At this cutoff, the screening assay was able to determine more than 90% of true results with 43.4% true positives and 48.7% true negatives. Four positive urines (5.3%) were not confirmed by HPLC-ES-MS. In only one case, the negative urine test was confirmed as positive by HPLC-ES-MS (buprenorphine: 62.5 ng/mL). Buprenorphine concentrations determined by HPLC-ES-MS ranged from 1.2 to 1052 ng/mL. Of the four potential adulterants (hypochloride 50 mL/L, sodium nitrite 50 g/L, liquid soap 50 mL/L, and sodium chloride 50 g/L) that might be added to a positive urine specimen, none were able to cause a false-negative response by the immunoassay. The results of this study support the concept that the Singlestep ELISA for buprenorphine determination in urine should be considered as a new, valided screening procedure.

Authors+Show Affiliations

Institut de Médecine Légale, Laboratoire de Toxicologie, 11, rue Humann, 67085 Strasbourg, France. vincent.cirimele@medecine.u-strasbg.frNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

12670004

Citation

Cirimele, V, et al. "Enzyme Immunoassay Validation for the Detection of Buprenorphine in Urine." Journal of Analytical Toxicology, vol. 27, no. 2, 2003, pp. 103-5.
Cirimele V, Kintz P, Lohner S, et al. Enzyme immunoassay validation for the detection of buprenorphine in urine. J Anal Toxicol. 2003;27(2):103-5.
Cirimele, V., Kintz, P., Lohner, S., & Ludes, B. (2003). Enzyme immunoassay validation for the detection of buprenorphine in urine. Journal of Analytical Toxicology, 27(2), 103-5.
Cirimele V, et al. Enzyme Immunoassay Validation for the Detection of Buprenorphine in Urine. J Anal Toxicol. 2003;27(2):103-5. PubMed PMID: 12670004.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enzyme immunoassay validation for the detection of buprenorphine in urine. AU - Cirimele,V, AU - Kintz,P, AU - Lohner,S, AU - Ludes,B, PY - 2003/4/3/pubmed PY - 2003/10/31/medline PY - 2003/4/3/entrez SP - 103 EP - 5 JF - Journal of analytical toxicology JO - J Anal Toxicol VL - 27 IS - 2 N2 - A solid-phase enzyme immunoassay involving microtiter plates was proposed by Microgenics to screen buprenorphine in urine. The intra-assay precision at 10 ng/mL was 7.7% (coefficient of variation). The immunoassay was determined to have no cross-reactivity with codeine, dihydrocodeine, morphine, ethylmorphine, 6-monoacetylmorphine, methadone, pholcodine, propoxyphene, dextromoramide, and dextromethorphan at 1 and 10 mg/L. A low cross-reactivity (3% at 1 ng/mL) was observed at low concentrations of norbuprenorphine. After comparing this new immunological test (Singlestep ELISA) for 76 urine specimens with our validated high-performance liquid chromatography-electrospray mass spectrometry (HPLC-ES-MS) procedure, an optimum cutoff concentration of 2 ng/mL was determined for the kit. At this cutoff, the screening assay was able to determine more than 90% of true results with 43.4% true positives and 48.7% true negatives. Four positive urines (5.3%) were not confirmed by HPLC-ES-MS. In only one case, the negative urine test was confirmed as positive by HPLC-ES-MS (buprenorphine: 62.5 ng/mL). Buprenorphine concentrations determined by HPLC-ES-MS ranged from 1.2 to 1052 ng/mL. Of the four potential adulterants (hypochloride 50 mL/L, sodium nitrite 50 g/L, liquid soap 50 mL/L, and sodium chloride 50 g/L) that might be added to a positive urine specimen, none were able to cause a false-negative response by the immunoassay. The results of this study support the concept that the Singlestep ELISA for buprenorphine determination in urine should be considered as a new, valided screening procedure. SN - 0146-4760 UR - https://www.unboundmedicine.com/medline/citation/12670004/Enzyme_immunoassay_validation_for_the_detection_of_buprenorphine_in_urine_ L2 - https://academic.oup.com/jat/article-lookup/doi/10.1093/jat/27.2.103 DB - PRIME DP - Unbound Medicine ER -