Prototype & proof-of-concept assays to optimize development time
INNOVATIVE ASSAYS
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:
The OEM Technology Center 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.
The European and USA markets are taking different approaches to Lyme disease diagnosis. Europe uses separate Lyme IgG and Lyme IgM assays while the USA uses a combined Lyme IgG+IgM assay.
Designing specific Lyme antigens allowed us to achieve excellent performance results for both IgG and IgM detection.
Market overview:
Comparison with selected reference methods, ELISA and chemiluminescence, showed good performance results for all prototypes.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescence platform of all our OEM partners.
INNOVATIVE ASSAYS
Parvovirus B19
Human parvovirus B19 belongs to the family Parvoviridae and is the only virus in this family known to be a human pathogen. This virus is the cause of the acute childhood infection called “fifth disease,” erythema infectiosum or, in lay terms, “slapped cheek syndrome.”
Our offer:
OEM Technology Center 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.
The design of specific parvovirus B19 virus-like particles consisting of the recombinant antigens VP1 and VP2, produced using IBES® (Improved Baculovirus Expression System) methodology, provides excellent sensitivity and specificity.
Market overview:
Comparison with selected reference methods, ELISA and chemiluminescence, showed good performance results for all prototypes.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescence platform of all our OEM partners.
INNOVATIVE ASSAYS
HTLV-I/II
Human T-cell lymphotropic viruses (HTLVs) are pathogenic retroviruses that may cause severe hematological and neurological diseases in infected individuals. The HTLV family comprises two well-studied members: HTLV-I and HTLV-II.
Our offer:
The OEM Technology Center has designed and developed an anti-HTLV-I/II assay, a fully automated chemiluminescent two-step immunoassay for the 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 the technical file for CE marking available.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescent platform of all our OEM partners.
INNOVATIVE ASSAYS
Mumps
Mumps (parotitis) virus has a worldwide distribution with humans as its only host. Transmission is by droplet infection and the main portal of entry is the upper respiratory tract.
Our offer:
The OEM Technology Center has designed and developed a mumps IgG assay, a fully automated chemiluminescent two-step immunoassay for the quantitative measurement of IgG antibodies to mumps virus in human serum or plasma using chemiluminescent immunoassay technology.
Market overview:
Mumps IgG reagents, calibrators and controls have the design dossier for CE marking available.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescent platform of all our OEM partners.
INNOVATIVE ASSAYS
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:
The OEM Technology Center has designed and developed VZV IgG and VZV IgM assays, fully automated chemiluminescent two-step immunoassays for the quantitative measurement of IgG or the 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 the design dossier for CE marking available.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescent platform of all our OEM partners.
INNOVATIVE ASSAYS
Measles
Measles virus is a highly contagious virus and measles disease has long been as a typical childhood infection. Before vaccination was introduced, the majority of children (95%-98%) had been infected by the age of ten.
Our offer:
The OEM Technology Center has designed and developed a Measles IgG assay, a fully automated chemiluminescent two-step immunoassay for the 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 the design dossier for CE marking available.
We can adapt the antigen and conjugate strategy used in order to better fit the target chemiluminescent platform of all our OEM partners.