Clinical Evaluation of QFlu Combo Test

Status:	Completed
Conditions:	Chronic Pain, Healthy Studies, Migraine Headaches, Other Indications, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Musculoskeletal, Neurology, Other
Healthy:	No
Age Range:	Any
Updated:	4/2/2016
Start Date:	November 2010
End Date:	July 2012

Currently effective antivials for influenza treatment are two influenza viral neuraminidase
inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is
reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is
that the signal ratio of two reagents (with or without a single concentration of the drug)
correlates the IC50 value, an accurate measurement of drug resistance but impractical for
clinical use.

The study design is to collect samples from participants. A portion of the sample is used
for drug resistance detection using the test (QFlu Combo Test) under investigation. The
remaining portion of the sample is used for culture. The culture positive samples are used
for determination of IC50 values, which is used as a gold standard for defining whether a
virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu
test will be calculated by comparing to the gold standard test.

Inclusion Criteria:

- Those who exhibit flu-like symptom(s) during a flu season and who (or whose
guardians) are willing to participate in the study.

We found this trial at

sites

University of Alabama at Birmingham

1720 2nd Ave S
Birmingham, Alabama 35233

(205) 934-4011