Prototype & Proof-of-Concept assays to optimize the development time

InnoAssays

Lyme Disease


Lyme disease, also known as Lyme Borreliosis, is caused by the spirochaete bacterium Borrelia burgdorferi, of which there are several different serotypes. It is transmitted to humans through the bite of infected blacklegged ticks

Our offer:

Biokit has designed and developed three Lyme prototype assays for the qualitative detection of IgG, IgM and IgG+IgM antibodies to Borrelia  sp. in human serum using chemiluminescent immunoassay technology

European and USA markets are using different approaches for Lyme disease diagnosis.  Europe uses separate Lyme IgG and Lyme IgM assays while USA market uses a combined Lyme IgG+IgM assay. 

Design of specific Lyme antigens allowed us to obtain excellent performance results, both for IgG and IgM detection.

Market overview:

Comparison with selected reference methods, ELISA and Chemiluminescence, showed good performance results for all the prototypes. 

We can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners

InnoAssays

Parvovirus B19


Human Parvovirus B19 belongs to the family Parvoviridae and is the only virus of this family known to be a human pathogen. This virus is the cause of the acute childhood infection called “fifth disease” or erythema infectious or in lay terms “slapped cheek syndrome”

Our offer:

Biokit has designed and developed two prototype assays for the qualitative detection of IgG antibodies and IgM antibodies to Parvovirus B19 in human serum using chemiluminescent immunoassay technology.

Design of specific Parvovirus B19 Virus Like Particles consisting of recombinant antigens VP1 and VP2, produced using the methodology IBES® (Improved Baculovirus Expression System) provides excellent sensitivity and specificity.
 

The process:

Comparison with selected reference methods, Chemiluminescence and ELISA, showed good performance results for all the prototypes. 

We can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners
 

InnoAssays

HTLV-I/II


Human T-cell Lymphotropic Viruses (HTLVs) are pathogenic retroviruses that may cause severe haematological and neurological diseases in infected individuals. The HTLV family comprises of two well-studied members: HTLV-I and HTLV-II.

Our offer:

Biokit has designed and developed an anti-HTLV-I/II assay, a fully automated chemiluminescent two-step immunoassay for qualitative measurement of antibodies specific for human T-Lymphotropic virus (HTLV) types I and II, in human serum or plasma using chemiluminescent immunoassay technology.

It is intended for use in clinical laboratories and as a first-line screening assay in blood centers.

Market overview:

Anti-HTLV-I/II reagents, calibrators and controls have available the technical file for CE mark.

Biokit can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners.

InnoAssays

Mumps


Mumps (Parotitis) Virus has a worldwide distribution with humans as the only host. Transmission is by droplet infection with the main portal of entry being the upper respiratory tract. 

Our offer:

Biokit has designed and developed a Mumps IgG assay, a fully automated chemiluminescent two-step immunoassay for quantitative measurement of IgG antibodies to Mumps Virus in human serum or plasma using chemiluminescent immunoassay technology.

The process:

Mumps IgG reagents, calibrators and controls have available the design dossier for CE mark.

Biokit can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners.

InnoAssays

Varicella


Varicella zoster virus (VZV) is an exclusively human virus that is present worldwide and is highly infectious. Primary infection leads to acute Varicella or “chickenpox”, usually from exposure either through direct contact with a skin lesion or through airborne spread from respiratory droplets.

Our offer:

Biokit has designed and developed VZV IgG and VZV IgM assays, fully automated chemiluminescent two-step immunoassay for quantitative measurement of IgG or qualitative measurement of IgM antibodies to Varicella Zoster virus in human serum or plasma using chemiluminescent immunoassay technology.

Market overview:

VZV IgG and VZV IgM reagents, calibrators and controls have available the design dossier for CE mark.

Biokit can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners.

InnoAssays

Measles


Measles Virus is a highly contagious virus and the Measles disease syndrome has long been established as a typical childhood infection. Before the introduction of vaccination the majority of children (95 - 98%) had been infected by the age of ten. 

Our offer:

Biokit has designed and developed a Measles IgG assay, a fully automated chemiluminescent two-step immunoassay for quantitative measurement of IgG antibodies to Measles Virus in human serum or plasma using chemiluminescent immunoassay technology.

The process:

Measles IgG reagents, calibrators and controls have available the design dossier for CE mark.

Biokit can adapt the antigen and conjugate strategy in order to better fit to the target chemiluminescent platform of all our OEM partners.