Oral Fluid Drug Testing of Chronic Pain Patients. II. Comparison of Paired Oral Fluid and Urine Specimens

Abstract

A clinical study was conducted to compare the use of oral fluid to urine for compliance monitoring of pain patients. Patients (n = 133) undergoing treatment for chronic pain at four clinics participated in the study and provided paired oral fluid and urine specimens. Oral fluid specimens were collected with Quantisal(TM) saliva collection devices immediately following urine collection. Oral fluid specimens were analyzed for 42 drugs and/or metabolites by validated liquid chromatography-tandem mass spectrometry procedures. Accompanying urine specimens were initially screened by immunoassay and non-negative results were confirmed. Of the 1544 paired tests, 329 (21.3%) drug analytes were positive, and 984 (63.7%) were negative for both specimens resulting in an overall agreement of 85%. There were 83 (5.4%) analyte results that were positive in oral fluid and negative in urine, and 148 (9.6%) were negative in oral fluid and positive in urine for an overall disagreement of 15%. Cohen's Kappa value was 0.64, indicating "substantial" agreement. The primary exceptions to agreement were the lower detection rates for hydromorphone, oxymorphone, and benzodiazepines in oral fluid compared to urine. The authors conclude that, overall, oral fluid tests produced comparable results to urine tests with some minor differences in detection rates for different drug classes.

Oral Fluid for The Detection of Drugs of Abuse Using Immunoassay and LC–MS/MS

“…After COC use, parent COC, as well as its metabolites BZE, norcocaine and cocaethylene, may be detected. Numerous articles have been published using LC-MS methods to confirm the presence of COC and its metabolites (specifically BZE) in OF specimens [22,32,[34][35][36][37][38][39][40]. MS/MS methods included the use of QQQ analyzers with MRM data acquisition [22,30,37,38].…”

“…MS/MS methods included the use of QQQ analyzers with MRM data acquisition [22,30,37,38]. Linear IT and Q-ToF instruments were also used for the analysis of COC and BZE [32,34,35]. When linear ITs were used, they were operated in MRM scan mode and acquisition methods were analogous to those used with the QQQ instruments [32,35].…”

“…Linear IT and Q-ToF instruments were also used for the analysis of COC and BZE [32,34,35]. When linear ITs were used, they were operated in MRM scan mode and acquisition methods were analogous to those used with the QQQ instruments [32,35]. Some methods were more focused on screening for COC and BZE [30] but most were versatile and included confirmation and/or quantification and incorporated deuterium-labeled stable isotope internal standards and used ESI in positive ion mode.…”

“…However, alternate API sources were assessed in at least one application [36]. The methods used various commercially available MS/MS instruments and the applications ranged broadly from pain management to driving under the influence investigation and workplace testing [23,35]. Extraction and sample handling methods included simple deproteinization or solvent dilution, LLE and SPE and automated platforms such as 96-well plates.…”

“…Proposed cutoff concentrations for screening and confirmation of COC and BZE in workplace programs are 20 and 8 ng/ml, respectively [3]. These cutoffs were easily obtained by MS/MS as demonstrated by cited publications of having validated LODs and LOQs of ≤2 ng/ml for both COC and BZE [22,32,35,37] and with LODs and LOQs of 5 ng/ml for COC and BZE, respectively [38].…”