Reagent Kits, Diagnostic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTFingerprint sweat drug screen
Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
DIAGNOSTIC_TESTFingerprint sweat laboratory analysis
Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
Sponsors
Intelligent Bio Solutions Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English. 2. \*Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been performed within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing. 4. \*Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg. 5. \*Females of childbearing potential must be willing to practice an acceptable form of contraception (see Section 9.3.3), and have a negative urine pregnancy test on admission to the treatment phase of the study. 6. \*Males must agree to practice an acceptable form of contraception. 7. \*Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.
Exclusion criteria
1. Unwilling or unable to provide informed consent. 2. \*More than three digits absent from the hands due to congenital or accidental cause(s). 3. \*Reports receiving any investigational drug within 30 days prior to dosing. 4. \*Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator). 5. \*Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit. 6. \*Is pregnant (females only). 7. \*Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator. 8. \*Reports history of respiratory depression (e.g., sleep apnea). 9. \*Current severe hypotension (i.e., systolic blood pressure <90 mmHg). 10. \*Reports known or suspected gastrointestinal obstruction including, paralytic ileus. 11. \*Reports current presence of acute bronchial asthma/ upper airway obstruction. 12. \*Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator. 13. \*Reports history or current condition of adrenal insufficiency. 14. \*Reports history or current condition of renal disease. 15. If, in the opinion of the Investigator, the subject is not suitable for the study. * Required only for "donors." Not required for "operators."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Method Comparison | 30 minutes to 3 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 72 hours | 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. |
Countries
United States
Outcome results
None listed