{"doi":"10.1002/dta.1633","title":"Validation of the only commercially available immunoassay for synthetic cathinones in urine: Randox Drugs of Abuse V Biochip Array Technology","abstract":"<jats:p>Deterrence of synthetic cathinone abuse is hampered by the lack of a high‐throughput immunoassay screen. The Randox Drugs of Abuse V (DOA‐V) Biochip Array Technology contains two synthetic cathinone antibodies: Bath Salt I (BSI) targets mephedrone/methcathinone and Bath Salt II (BSII) targets 3’,4’‐methylenedioxypyrovalerone (MDPV)/3’,4’‐methylenedioxy‐α‐pyrrolidinobutiophenone (MDPBP). We evaluated DOA‐V synthetic cathinones performance and conducted a full validation on the original assay with calibrators reconstituted in water, and the new assay with calibrators prepared in lyophilized urine; both utilized the same antibodies and were run on the fully automated Evidence® Analyzer. We screened 20 017 authentic military urine specimens and confirmed positives by liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) for 28 synthetic cathinones. Limits of detection (LOD) for the original and new assays were 0.35 and 0.18 (BSI), and 8.5 and 9.2 µg/L (BSII), respectively. Linearity was acceptable (R<jats:sup>2</jats:sup> &gt; 0.98); however, a large negative bias was observed with in‐house prepared calibrators. Intra‐assay imprecision was &lt;20% BSI‐II, while inter‐assay imprecision was 18‐42% BSI and &lt;22% BSII. Precision was acceptable for Randox controls. Cross‐reactivities of many additional synthetic cathinones were determined. Authentic drug‐free negative urine pH &lt;4 produced false positive results for BSI (6.3 µg/L) and BSII (473 µg/L). Oxidizing agents reduced BSI and increased BSII results. Sensitivity, specificity, and efficiency of 100%, 52.1%, and 53.0% were obtained at manufacturer's proposed cut‐offs (BSI 5 µg/L, BSII 30 µg/L). Performance improved if cut‐off concentrations increased (BSI 7.5 µg/L, BSII 40 µg/L); however, there were limited confirmed positive specimens. Currently, this is the first and only fully validated immunoassay for preliminary detection of synthetic cathinones in urine. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.</jats:p>","journal":"Drug Testing and Analysis","year":2014,"id":680215,"datarank":0.6329261557764161,"base_score":4.219507705176107,"endowment":4.219507705176107,"self_citation_contribution":0.6329261557764161,"citation_network_contribution":0.0,"self_endowment_contribution":0.6329261557764161,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":67,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1777241,"name":"Sébastien Anizan","orcid":null,"position":1,"is_corresponding":false},{"id":1777242,"name":"Marisol S. Castaneto","orcid":null,"position":2,"is_corresponding":false},{"id":1777244,"name":"Nathalie A. Desrosiers","orcid":null,"position":3,"is_corresponding":false},{"id":316544,"name":"Thomas M. Martin","orcid":"0000-0002-1671-6498","position":4,"is_corresponding":false},{"id":1777245,"name":"Kevin L. Klette","orcid":null,"position":5,"is_corresponding":false},{"id":126413,"name":"Marilyn A. Huestis","orcid":null,"position":6,"is_corresponding":false},{"id":1777238,"name":"Kayla N. Ellefsen","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Validation of the only commercially available immunoassay for synthetic cathinones in urine: Randox Drugs of Abuse V Biochip Array Technology","abstract":"<jats:p>Deterrence of synthetic cathinone abuse is hampered by the lack of a high‐throughput immunoassay screen. The Randox Drugs of Abuse V (DOA‐V) Biochip Array Technology contains two synthetic cathinone antibodies: Bath Salt I (BSI) targets mephedrone/methcathinone and Bath Salt II (BSII) targets 3’,4’‐methylenedioxypyrovalerone (MDPV)/3’,4’‐methylenedioxy‐α‐pyrrolidinobutiophenone (MDPBP). We evaluated DOA‐V synthetic cathinones performance and conducted a full validation on the original assay with calibrators reconstituted in water, and the new assay with calibrators prepared in lyophilized urine; both utilized the same antibodies and were run on the fully automated Evidence® Analyzer. We screened 20 017 authentic military urine specimens and confirmed positives by liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) for 28 synthetic cathinones. Limits of detection (LOD) for the original and new assays were 0.35 and 0.18 (BSI), and 8.5 and 9.2 µg/L (BSII), respectively. Linearity was acceptable (R<jats:sup>2</jats:sup> &gt; 0.98); however, a large negative bias was observed with in‐house prepared calibrators. Intra‐assay imprecision was &lt;20% BSI‐II, while inter‐assay imprecision was 18‐42% BSI and &lt;22% BSII. Precision was acceptable for Randox controls. Cross‐reactivities of many additional synthetic cathinones were determined. Authentic drug‐free negative urine pH &lt;4 produced false positive results for BSI (6.3 µg/L) and BSII (473 µg/L). Oxidizing agents reduced BSI and increased BSII results. Sensitivity, specificity, and efficiency of 100%, 52.1%, and 53.0% were obtained at manufacturer's proposed cut‐offs (BSI 5 µg/L, BSII 30 µg/L). Performance improved if cut‐off concentrations increased (BSI 7.5 µg/L, BSII 40 µg/L); however, there were limited confirmed positive specimens. Currently, this is the first and only fully validated immunoassay for preliminary detection of synthetic cathinones in urine. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.</jats:p>","is_dataset_classified":null,"base_score":4.219507705176107,"endowment":4.219507705176107,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"24659527","pmcid":"PMC4107059","openalex_id":"https://openalex.org/W1564570507","authors":[],"funders":[{"funder_name":"Intramural NIH HHS","grant_id":"ZIA DA000413","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"","title":null},{"funder_name":"Department of Defense Counter Narcotics Program","grant_id":"","title":null}],"total_grants":3,"fwci":4.1525,"citation_percentile":0.9430114,"influential_citations":0,"citation_trend":[{"year":2013,"count":1},{"year":2014,"count":6},{"year":2015,"count":3},{"year":2016,"count":7},{"year":2017,"count":7},{"year":2018,"count":9},{"year":2019,"count":13},{"year":2020,"count":4},{"year":2021,"count":5},{"year":2022,"count":4},{"year":2023,"count":2},{"year":2024,"count":3},{"year":2025,"count":1},{"year":2026,"count":1}],"oa_status":"green","license":"http://onlinelibrary.wiley.com/termsAndConditions#vor","oa_locations":[{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4107059","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4107059","host_type":"repository"},{"url":"https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1002%2Fdta.1633","host_type":"publisher"},{"url":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/pdf/10.1002/dta.1633","host_type":"publisher"},{"url":"https://doi.org/10.1002/dta.1633","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/24659527","host_type":"repository"}],"fields_of_study":["Forensic Toxicology and Drug Analysis","Nicotinic Acetylcholine Receptors Study","Psychedelics and Drug Studies","Alkaloids","Humans","Illicit Drugs","Immunoassay","Limit of Detection","Methamphetamine","Protein Array Analysis","Substance Abuse Detection"],"mesh_terms":["Alkaloids","Humans","Immunoassay","Methamphetamine","Illicit Drugs","Substance Abuse Detection","Protein Array Analysis","Limit of Detection"],"keywords":["Chromatography","Mephedrone","Cathinone","Synthetic cannabinoids","Drugs of abuse","Immunoassay","Chemistry","Biochip","Analyte","Detection limit","Urine","Pharmacology","Medicine","Drug","Antibody","Nanotechnology","Materials science","Internal medicine","Synthetic Cathinones","Mdpv","Randox"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-17T14:37:35.476856Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}