Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
Study NCT ID:
NCT05692505
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Sponsor:
Genlantis Diagnostics
Organization:
Study Overview
Official Title:
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
NOT_YET_RECRUITING
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 (p\<=0.02) 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 don't 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 (p\<=0.02) 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 don't 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:
False
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?: