Protocol for Accuracy of Point of Care (POC) or
In-Office Urine Drug Testing (Immunoassay) in
Chronic Pain Patients: A Prospective Analysis of
Immunoassay and Liquid Chromatography Tandem
Mass Spectometry (LC/MS/MS)
Authors: Manchikanti Laxmaiah 
Published: March 2021

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic
non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along
with the public and federal, state, and local government; professional associations; and pharmaceutical
companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to
eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment
of those patients. A number of techniques, instruments, and tools have been described to monitor controlled
substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine
drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine
drug testing is associated with multiple methodological flaws.
Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions
about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies
systematically assessing the diagnostic accuracy of immunoassay with laboratory testing.
Study Design: A diagnostic accuracy study of urine drug testing.
Study Setting: An interventional pain management practice, a specialty referral center, a private practice
setting in the United States.
Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing
(index test) to the information found when all drugs and analytes are tested by liquid chromatography
tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample.
Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled
substances.
The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled
substances, including opioids, benzodiazepines, and illicit drugs.
The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies
(STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of
reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized.
Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels,
prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics
will be calculated.
Limitations: The limitations include lack of availability of POC testing with lower cutoff levels.
Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The
protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of
abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics.
Clinical Trial Registration: NCT 01052155
Key words: Controlled substances, opioids, benzodiazepines, illicit drugs, abuse, diversion, adherence
monitoring, prescription monitoring programs