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α-fetoprotein (AFP) is produced during embryonic development and found in high concentrations in fetal serum. AFP has been shown to be elevated in patients with hepatocellular carcinoma.

Tau proteins are mainly present in neurons and play a role in axonal microtubule stability. An increase of Tau is considered as a biomarker for neuronal death and as such often included in diagnostic algorithms for Alzheimer’s disease.

Qualitative detection and identification of 15 High-Risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68.

Fujirebio produces antigens both from human cell lines and as recombinant products from Escherichia coli (E.coli) and CHO cells.

Offers fully automated processing of INNO-LIA tests from sample incubation to color development, ensuring ease of use, speed, and confidence.

Offers fully automated processing for the complete range of INNO-LiPA and INNO-LIA tests from hybridization to color development.

The C50 MAb defines carcinoma associated carbohydrate antigens, which are present in carcinomas of many organs and of different histopathological types.

The MUC-1 breast cancer antigen is a mucin-type glycoprotein. It is secreted from tumor cells and can be used as a serological marker of breast cancer.

The CanAg AFP EIA kit is intended for the quantitative determination of α-Fetoprotein (AFP) in human serum.

The CanAg CA15-3 EIA kit is intended for the quantitative determination of the cancer associated antigen MUC-1 (CA15-3) in serum.

The CanAg CA242 EIA kit is intended for the quantitative determination of CA242 cancer antigen in serum.

The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

The CanAg NSE EIA kit is intended for the quantitative determination of NSE in human serum.

The CanAg PSA EIA kit is intended for the quantitative determination of Total PSA (Prostate Specific Antigen) in human serum.

The CanAg SCC EIA kit is intended for the quantitative determination of squamous cell carcinoma (SCC) antigen in serum as an aid in the management of patients with squamous cell carcinoma.

Epitope characterization has revealed five major antigenic domains of CEA, “Gold epitope 1-5”.

Colli-Pee is a device especially designed for first-void urine collection by capturing the first 20ml of a urine sample more efficiently and requiring less effort from the user.

Reagent for detection of influenza A & B virus antigens.

The combination of antibodies against hidden epitopes of PSA with antibodies against exposed epitopes may be used for the development of specific assays for detection of Free PSA.

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is further intended to be used in conjunction with either ARCHITECT CA 125 II or CanAg CA125 EIA or Lumipulse G CA125II as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.

For research use with the LUMIPULSE G system for the quantitative measurement of IL-6 in serum or plasma.

Fujirebio Europe NV is active in the field of confirmatory testing for infectious diseases for many years. We produce recombinant antigens using Escherichia coli production systems. These materials are part of our INNOTEST or INNO-LIA products and are available for use in other diagnostic platforms.

Line immunoassay for the detection of antibodies to human hepatitis C virus in human serum and plasma.

Line immunoassay for the confirmation and discrimination of antibodies to Human T-cell Lymphotrophic Virus type I (HTLV-I) and type II (HTLV-II) in human serum and plasma.

Line immunoassay for the confirmation of antibodies to Treponema pallidum in human serum and plasma.

Line probe assay, intended for the simultaneous in vitro detection and identification of 18 human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and their wild type sequence in human whole blood, dried blood spots or buccal brushes.

Multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 36 cystic fibrosis-related mutations and their wild-type sequences in human whole blood, dried blood spots, and buccal brush samples.

Line probe assay designed to identify hepatitis B virus genotypes A to H by the detection of type-specific sequences in the HBV polymerase gene domain B to C.

Line probe assay for simultaneous detection of hepatitis B virus wild-type motif, lamivudine, telbivudine, emtricitabine, adefovir, and entecavir resistance-associated mutations.

Line probe assay for the molecular typing of human leukocyte antigen (HLA) A alleles at allele group level (A*01–A*80).

Line probe assay for the molecular typing of human leukocyte antigen (HLA) C alleles at allele group level (Cw*01 – Cw*18).

Line probe assay for the molecular typing of human leukocyte antigen (HLA) DQB1 alleles at allelic level (DQB1*02–DQB1*06).

Line probe assay for the molecular typing of human leukocyte antigen (HLA) DRB1 alleles at allele group level (DRB1*01–DRB1*16).

Line probe assay for the simultaneous detection and identification of the genus Mycobacterium and 16 different mycobacterial species.

Solid-phase enzyme immunoassay for the quantitative determination of β-amyloid(1-40) in human cerebrospinal fluid (CSF) in the clinical setting of dementia diagnosis.

Solid-phase enzyme immunoassay for the quantitative determination of β-amyloid(1-42) in human cerebrospinal fluid (CSF).

Enzyme immunoassay for the qualitative detection of HIV p24 antigen in human serum, plasma, and cell culture supernatant.

Solid-phase enzyme immunoassay for the quantitative determination of Tau protein in human cerebrospinal fluid (CSF).

Solid-phase enzyme immunoassay for the quantitative determination of phosphorylated Tau (Phospho-Tau(181P)) in human cerebrospinal fluid (CSF).

Objective reading and interpretation of INNO-LIA® strips for infectious diseases.

Objective reading of INNO-LIA® ANA strips for detection of 13 specific antibodies.

Objective reading and interpretation of the INNO-LIPA® HBV portfolio.

Objective reading and interpretation of the INNO-LiPA® strips for HLA typing.

Objective reading and interpretation of the INNO-LiPA® strips for HPV Genotyping Extra.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the fully automated quantitative measurement of AMH in specimens based a two-step immunoassay method on the LUMIPULSE G System.

For in vitro diagnostics (IVD) use with the LUMIPULSE G System for the quantitative measurement of ß2-microglobulin (ß2m) in serum, plasma and urine.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of beta human chorionic gonadotropin (βHCG) in serum or plasma.

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of human B-type natriuretic peptide (BNP) on the LUMIPULSE G Systems.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of CA125 in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of CA19-9-N in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of the MB iso-enzyme of the creatine kinase (CK-MB) in human serum or plasma. This product is for professional use only.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of cytokeratin subunit 19 fragment (CYFRA) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of ferritin in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of follicle-stimulating hormone (FSH) in serum or plasma.

For in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free thyroxine (FT4) in serum or plasma.

Immunoreaction cartridges set for Research Use Only (not for use in diagnostic precedures) with the LUMIPULSE G System for the quantitative detection of hepatitis B virus core-related antigen in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the qualitative detection of antibody to hepatitis B e antigen (anti-HBe) in human serum or plasma. This product is indicated as an aid in the diagnosis and monitoring of hepatitis B viral infection and for professional use only.

Immunoreaction cartridges for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative and quantitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of high-molecular-weight adiponectin (HMW Adiponectin) in serum or plasma.based on CLEIA technology by two-step sandwich immunoassay method on the LUMIPULSE G system and with results that are available in up to 30 minutes.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of immunoglobulin E (IgE) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of luteinizing hormone (LH) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of myoglobin in human serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of pepsinogen I in specimens based on CLEIA technology by two-step sandwich immunoassay method on the LUMIPULSE G system.

Assayed control to monitor the precision of laboratory testing procedures for the analysis of Pepsinogen I and Pepsinogen II on the LUMIPULSE G Systems.

Assayed control serum to monitor the precision of laboratory testing procedures for the analysis of PIVKA-II and KL-6 using LUMIPULSE Systems.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Pro-gastrin-releasing peptide [ProGRP (31-98)] in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of prostate specific antigen (PSA) in serum or plasma.

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of whole (1-84) PTH on the LUMIPULSE G Systems.

These controls are intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analysis of SARS-CoV-2 antigen on the LUMIPULSE G System.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of testosterone in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of thyroxine (T4) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the qualitative measurement of treponema pallidum (TP) antibodies (IgG and IgM) in serum or plasma. Includes calibrators.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of triiodothyronine (T3) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma.

Lung Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analysis of CYFRA and ProGRP with the LUMIPULSE G system.

The glycolytic enzyme enolase (2-phospho-D-glycerate hydrolase, EC 4.2.1.11) exists as several dimeric isoenzymes (αα,αβ, αγ, ββ and γγ).

Power-Gene 9600 Plus adopts Ferrotec specially-made Peltier, advanced fiber optic technology, new global wide-range power supply, the unique patented block dissipation technology and bottom detection mode, which provides better heating/cooling rate, temperature accuracy, uniformity and stability.

Assayed control to monitor the performance of laboratory testing procedures for the analysis of Anti-HIV 1, IgG Anti-HBc, Anti-HTLV Ig, Anti-HCV IgG HBsAg, Anti-Treponema pallidum IgG analytes in human serum and plasma.

Fully automated processing of INNO-LIA® tests from sample pipetting to strip reading and LiRAS® interpretation**, transforming tedious manual work into a completely automated throughput of high testing volumes, ensuring ease of use, chain of custody (Pos ID), and consistent performance

Particle-agglutination Trypanosoma cruiz antibody test.

Particle-agglutination test for the detection of antibodies to Human T Lymphotropic Retrovirus type I (HTLV-I).

Particle-agglutination test for the detection of antibodies to Treponema Pallidum.

Assayed quality control serum to monitor the precision of laboratory measurement procedures.

D-Dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. D-dimer concentration may be determined in a test to help diagnose thrombosis.

Treponema pallidum Line Immunoblot assay is for in vitro diagnostic (IVD) use for the qualitative detection of Treponema pallidum specific IgG- respectively IgM- antibodies in human serum.