Prospective, open-label, single-dose, randomized, multi-site performance evaluation of the accuracy and usability Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."
This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting DSC-7 Drug Screening Cartridge versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, within healthy males and non-pregnant females. The primary objective is to compare the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System to the validated confirmatory LC-MS/MS technique. The secondary objectives are to assess drug screening system usability and reproducibility. "Operators" comprise nine (9) adults: male and female subjects who operate the drug screening system. These subjects are not administered any drug. "Operators" represent end users who utilize the screening system in a laboratory setting. "Operators" will be provided the Intelligent Fingerprinting Drug Screening Guide, Confirmatory Laboratory Analysis Guide, and Quick Reference Guide, and be trained in system use. After receiving and reviewing all materials, the "operator" will complete a Training Exam to determine if he or she may proceed with testing. "Donors" comprise 135 healthy adults: male and non-pregnant female subjects who provide fingerprint sweat specimens. Subjects will be randomized into the blocks administered 0, 30, or 60mg of codeine sulfate in tablet form. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening.
Study Type
OBSERVATIONAL
Enrollment
135
Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
CenExel iResearch
Decatur, Georgia, United States
RECRUITINGCenExel HRI
Berlin, New Jersey, United States
RECRUITINGCenExel HRI
Marlton, New Jersey, United States
RECRUITINGMethod Comparison
Comparison of the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System (qualitative lateral-flow immunoassay) to the validated confirmatory LC-MS/MS technique
Time frame: 30 minutes to 3 hours
Usability
Usability of the Intelligent Fingerprinting Drug Screening System based on scores obtained by operators on written training exam (Drug Screening Process and Laboratory Process Exam). Training exam score must meet or exceed 85% for each operator.
Time frame: 72 hours
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