Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618183
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Drug Screening System Method Comparison
Sponsor:
None
Organization:
None
Study Overview
Official Title:
User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System Method Comparison and Usability
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-MSMS 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 andor periodic workplace drug screening
The primary objective is to compare the sensitivity specificity and accuracy of the Intelligent Fingerprinting Drug Screening System to the validated confirmatory LC-MSMS 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 andor periodic workplace drug screening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None