Reagent Kits, DiagnosticNCT06618183
Drug Screening System Method Comparison
An observational study of Reagent Kits, Diagnostic, run by Intelligent Bio Solutions Inc. at 3 sites in United States.
Trial 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." Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Reagent Kits, Diagnostic
- What is being tested?
- Fingerprint sweat drug screen and Fingerprint sweat laboratory analysis
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Aug 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from the community at large.
Who may be able to join
- 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.
- *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.
- Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing.
- *Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg.
- *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.
- *Males must agree to practice an acceptable form of contraception.
- *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.
Who cannot join
- Unwilling or unable to provide informed consent.
- *More than three digits absent from the hands due to congenital or accidental cause(s).
- *Reports receiving any investigational drug within 30 days prior to dosing.
- *Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
- *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.
- *Is pregnant (females only).
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- *Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
- *Reports history of respiratory depression (e.g., sleep apnea).
- *Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
- *Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
- *Reports current presence of acute bronchial asthma/ upper airway obstruction.
- *Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
- *Reports history or current condition of adrenal insufficiency.
- *Reports history or current condition of renal disease.
- If, in the opinion of the Investigator, the subject is not suitable for the study.
- Required only for \"donors.\" Not required for \"operators.\"
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
CenExel HRI
Berlin, New Jersey, 08009
Danielle Brudon, B.S, 856.753.7335 ext. 339, d.brudon@cenexel.com
Cassie Blanchard, PhD
- Recruiting
CenExel iResearch
Decatur, Georgia, 30030
Candice Hartley, M.Ed., Ed.S., 404-537-1281, c.hartley@cenexel.com
Kimball Johnson, MD
- Recruiting
CenExel HRI
Marlton, New Jersey, 08053
Lindsay Moellers, 856-452-9901, l.moellers@cenexel.com
Elan Cohen, PhD
About this study
Official title: User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability
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."
Read the 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.
- Conditions
- Reagent Kits, Diagnostic
- Being tested
- Fingerprint sweat drug screen, Fingerprint sweat laboratory analysis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerprint sweat drug screenDiagnostic test
Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
Fingerprint sweat laboratory analysisDiagnostic test
Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| 1 | Donors randomized into the 0 mg codeine dosage block Receives: Diagnostic Test: Fingerprint sweat drug screen; Diagnostic Test: Fingerprint sweat laboratory analysis | |
| 2 | Donors randomized into the 30 mg codeine dosage block Receives: Diagnostic Test: Fingerprint sweat drug screen; Diagnostic Test: Fingerprint sweat laboratory analysis | |
| 3 | Donors randomized into the 60 mg codeine dosage block Receives: Diagnostic Test: Fingerprint sweat drug screen; Diagnostic Test: Fingerprint sweat laboratory analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method 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
Measured: 30 minutes to 3 hours
Secondary outcomes (1)
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reagent Kits, DiagnosticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelligent Bio Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618183
- Sponsor's protocol ID
- IBS-2024-02
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability
- ClinicalTrials.gov ID
- NCT06618183
- Acronym / sponsor ID
- IBS-2024-02
- Conditions
- Reagent Kits, Diagnostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Intelligent Bio Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Fingerprint sweat drug screen, Diagnostic Test: Fingerprint sweat laboratory analysisDonors randomized into the 0 mg codeine dosage block |
| 2 | – | Diagnostic Test: Fingerprint sweat drug screen, Diagnostic Test: Fingerprint sweat laboratory analysisDonors randomized into the 30 mg codeine dosage block |
| 3 | – | Diagnostic Test: Fingerprint sweat drug screen, Diagnostic Test: Fingerprint sweat laboratory analysisDonors randomized into the 60 mg codeine dosage block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the community at large.
Key inclusion criteria (7 listed)
- 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.
- *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.
- Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing.
- *Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg.
- *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.
Key exclusion criteria (16 listed)
- Unwilling or unable to provide informed consent.
- *More than three digits absent from the hands due to congenital or accidental cause(s).
- *Reports receiving any investigational drug within 30 days prior to dosing.
- *Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
- *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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingerprint sweat drug screenQualitative lateral-flow immunoassay analysis of fingerprint sweat specimen | Diagnostic test | 1, 2, 3 |
| Fingerprint sweat laboratory analysisLaboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry | Diagnostic test | 1, 2, 3 |
Primary outcome
Method Comparison
Time frame: 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
1 secondary outcome
Usability
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reagent Kits, Diagnostic, run by Intelligent Bio Solutions Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method Comparison (time frame: 30 minutes to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.