Update on Clinical Trials
By Robert Zeiler, PhD
The past year has seen the development of a new IVD (Invitro Diagnostic Device) by Genlantis Diagnostics called TriQuik. This device is able to detect HEP-B, HEP-C and HIV with one drop of blood and takes about 15 minutes for results. It requires no special laboratory equipment nor any specially trained personnel. As Chief Scientific Officer for the company at the time, I designed the clinical trial and wrote the protocol with the other necessary documents to start this trial. The protocol is entitled “A clinical performance study to compare the results obtained from the TriQuik™ Rapid Diagnostic test (Cassette) Invitro Diagnostic Device with historical medical record from the same subject.”
This work is currently ongoing. The goal of the project is to obtain the necessary information and data to submit to the FDA for approval. Following receipt of approval, the company plans to distribute the devices globally, concentrating on underserved populations and countries.
Diagnostic tests are used to determine, verify, or confirm a patient’s clinical condition as a sole determinant. This type of testing also includes sole confirmatory assays (to verify results of previous testing) and sole exclusion assays (to rule out a particular condition).
Screening tests are used to determine the status of a disease, disorder, or other physiological state in an asymptomatic individual. These types of tests include genetic screening assays, tests for physiological typing, and tests used to reduce the risk of infectious disease transmission, such as assays for prenatal screening and donor screening (transfusion or transplantation).