iLite^TM alphaCE

Neutekbio's iLite^TM alphaCE is a CE marked test designed as a replacement for the conventional IFNα bioassay (i.e., viral inhibition assay in cell culture) in those diagnostic applications in which that test has been demonstrated to be clinically useful.

After an 18 hour incubation period of patient sample with the iLite^TM reporter cells, the assay can detect 0.8 IU per ml of clinical sample and demonstrates an acceptable correlation with a viral inhibition assay employing MDBK cells and VSV.

Potential diagnostic applications of iLite^TM alphaCE include:

Aid to the physician in the early diagnosis of acute viral infection

Acting through the "Toll-Like Receptor" (TLR) mechanism, one of the earliest reactions of the human body to viral infection is the production of IFNα by the antigen processing cells (APCs) of the immune system.

This was recognized several years ago by Dr. Pierre Lebon and his colleagues and many papers have been published describing the correlation between the detection of IFNα in patient sample (i.e., serum or cerebrospinal fluid) and early viral infection. Many of these papers are cited in the "Related Literature" section of this website.

In certain hospital and clinical laboratories in Europe, the detection of IFNα in biological fluids collected from neonates, organ transplant patients and pregnant women has been used as a diagnostic marker to aid the physician in the early diagnosis of acute viral infection.

Monitoring Patients Undergoing IFNα Therapy

IFNα in its pegylated form, is used to treat chronic HCV infections. The current therapeutic regimen involves the weekly injection of 10 million IU of IFNα on a weekly basis.

Because of the problematic nature of the conventional bioassay, monitoring serum half-life has never been considered on an individual patient basis. Obviously, clearance rates differ considerably among the patient population.

Given the expense of IFNα treatment, the severe toxic side-effects and the observation that only a subset of treated patients shows long term cure, optimization of individual therapy appears potentially important to the healthcare system.

The iLite^TM alphaCE test provides an efficient and reliable method to monitor patient IFNα levels on a regular basis during therapy.