Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05692505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Brief Title:
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Sponsor:
Genlantis Diagnostics
Organization:
Genlantis Diagnostics
Study Overview
Official Title:
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Detailed Description:
Measurement Methodology Whole blood samples are collected by fingerstick Samples tested immediately
Using the supplied sample dropper transfer specimen blood drop into the two sample wells Wait 20-30 seconds Add two drops of the supplied assay buffer 90µL to the same sample wells Read result in 20 mins
Primary end points will determine how accurate these tests are p002 by analyzing for
Diagnostic Sensitivity TP TP FN The ability of the test to correctly identify those patients with the disease Diagnostic Specificity TN TN FP The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value TP TP FP The probability that subjects with a positive test truly have the disease Negative Predictive Value TN FN TN The probability that subjects with a negative test truly dont have the disease
An estimated 200 patients are to be enrolled as follows
150 with a documented medical history of HIV HBV HCV or Syphilis A combination of 2 or 3 conditions is acceptable
HbsAg patients need to have a HbsAg on file 2 years HIV and HCV or Syphilis patients only need one antibody test in their medical chart
50 with no documented medical history of HIV HBV HCV or Syphilis and are considered normal
Male or female subjects ages 18 years
Using the supplied sample dropper transfer specimen blood drop into the two sample wells Wait 20-30 seconds Add two drops of the supplied assay buffer 90µL to the same sample wells Read result in 20 mins
Primary end points will determine how accurate these tests are p002 by analyzing for
Diagnostic Sensitivity TP TP FN The ability of the test to correctly identify those patients with the disease Diagnostic Specificity TN TN FP The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value TP TP FP The probability that subjects with a positive test truly have the disease Negative Predictive Value TN FN TN The probability that subjects with a negative test truly dont have the disease
An estimated 200 patients are to be enrolled as follows
150 with a documented medical history of HIV HBV HCV or Syphilis A combination of 2 or 3 conditions is acceptable
HbsAg patients need to have a HbsAg on file 2 years HIV and HCV or Syphilis patients only need one antibody test in their medical chart
50 with no documented medical history of HIV HBV HCV or Syphilis and are considered normal
Male or female subjects ages 18 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None