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The HAVAb IgG II assay is a chemiluminescent microparticle immunoassay (CMA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric (4 through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin separator, dipotassium EDTA, and tripotassium EDTA tubes) from patients with signs and symptoms or at risk for hepatitis A on the Alinity i system. The HAVAb IgG II assay is used to determine the immune status of individuals to hepatitis A virus (HAV) infection. Warning: This assay has not been cleared for use in screening blood, plasma, or tissue donors. This assay camot be used for the diagnosis of acute HAV infection. Assay performance characteristics have not been established when the HAVAb IgG II assay is used in conjunction with other hepatitis assays.

The HAVAb IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric (4 through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin separator, dipotassium EDTA, and tripotassium EDTA tubes) from patients with signs and symptoms or at risk for hepatitis A on the Alinity i system. The kit includes reagents (Microparticles, Conjugate, Assay Diluent), Calibrator, and Controls. The assay is an automated, two-step immunoassay.

The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family*. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients. This assay is not intended for screening blood or solid or soft tissue donors.

The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only. The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminolantibody conjugate).

The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients. This assay is not intended for screening blood or solid or soft tissue donors.

The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only. The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjugate).

The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presponse to HAV in vaccine recipients. The assay is not intended for screening blood or solid or soft tissue donors.

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IqG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjuqate). The first incubation step consists of adding the HAV antigen to calibrators, samples or controls, during which anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV. thus forming an HAV-anti-HAV immune complex. After this step the second incubation follows and it involves addition of magnetic microparticles and conjugate into the cuvette, during which the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV. This allows the conjugate to bind to the solid phase and to form a sandwich. If all HAV added is sequestered in an HAV-anti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.

Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li-heparin, potassium EDTA, Na-hebarin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e immunoassay analyzers. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Elecsys Anti-HAV II is a second generation assay by Roche Diagnostics for the in vitro qualitative detection of total antibodies (IgG and IgM) to the hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology. The assay is an 18-minute assay utilizing a competition principle. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. The reagent rackpack working solutions include: - M: Streptavidin-coated microparticles . - R1: HAV Ag (cell culture) . - R2: Biotinylated monoclonal anti-HAV antibody, monoclonal Anti-HAV antibody . labeled with ruthenium complex - AHAV 2 Cal1: Negative Calibrator 1 (human serum) . - AHAV 2 Cal2: Positive Calibrator 2 (anti-HAV (human), approximately 60 IU/L in . human serum) PreciControl Anti-HAV II is a ready-for-use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the performance of the Elecsys Anti-HAV II immunoassay. PreciControl Anti-HAV II is sold separately from the Elecsys Anti-HAV II immunoassay reagent.

ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems: The ADVIA Centaur® HAV (gM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age. ADVIA Centaur CP system: The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.

The ADVIA Centaur HAV IgM reagent kit contains the following: - ReadyPack® primary reagent pack containing ADVIA Centaur HAV IgM Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent - ReadyPack ancillary pack containing ADVIA Centaur HAV IgM Ancillary Reagent - ADVIA Centaur HAV IgM Low Calibrator - ADVIA Centaur HAV IgM High Calibrator - ADVIA Centaur systems HAV IgM Master Curve cards - ADVIA Centaur systems HAV IgM Calibrator Assigned Value Card The HAV IgM ReadyPack consists of the following: Primary reagent pack - The Lite Reagent is an anti-HAV mouse monoclonal antibody (F(ab) ¿ fragment: ~0.3 µg/mL) labeled with acridinium ester in buffer with bovine serum albumin, surfactant, sodium azide (<0.1%), and preservatives - . The Solid Phase is streptavidin coated paramagnetic microparticles in buffer with bovine serum albumin, surfactant, sodium azide (< 0.1%), and preservatives - The Ancillary Well Reagent is inactivated purified hepatitis A virus (<0.1 uq/mL) in ● buffer with bovine serum albumin, surfactant, sodium azide (<0.1%), and preservatives Ancillary pack - The Ancillary Reagent is biotinylated monoclonal mouse anti-human IgM (~0.500 . uq/mL) in buffer with bovine serum albumin, mouse IgG, surfactant, sodium azide (< 0.1%), and preservatives HAV IgM Calibrators - Processed human plasma negative and positive for anti-HAV IgM antibodies with sodium azide (< 0.1%) and preservatives

The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and plasma (sodium citrate, potassium EDTA, lithium and sodium heparin, and citrate dextrose (ACD)) using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection. This assay is not intended for screening blood or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations. The LIAISON® Control HAV IgM (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.

The method for qualitative determination of HAV IgM is an antibody capture chemiluminescence immunoassay (CLIA). IgG to human IgM (mouse monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to HAV is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HAV antigen just added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of anti-HAV IgM present in calibrators, samples or controls.

ADVIA Centaur and ADVIA Centaur XP systems: The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative deternination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP systems. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or HAVsusceptible individuals for vaccination. Assay performance characteristics have not been established for immunosompromised or immunosuppressed patients. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician. ADVIA Centaur CP system: The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative deternination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection of HAV-susceptible individuals for vaccination. Assay performance characteristics have not been established for immunosuppressed patients. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

The ADVIA Centaur HAVT reagent kit contains the following: - ReadyPack primary reagent pack containing ADVIA Centaur HAVT Lite Reagent, Solid Phase Reagent, and Antigen Reagent - ReadyPack ancillary pack containing ADVIA Centaur HAVT Ancillary Reagent - ADVIA Centaur HAVT Low Calibrator - ADVIA Centaur HAVT High Calibrator - ADVIA Centaur systems HAVT Master Curve card - ADVIA Centaur systems HAVT Calibrator Assigned Value Card The HAVT ReadyPack consists of the following: Primary reagent pack - The Lite Reagent is an anti-human HAV monoclonal antibody (~1.0 ug/mL) labeled with acridinium ester and biotinylated monoclonal mouse anti-HAV Fab fragment (~0.08 µg/mL) in phosphate buffer with bovine serum albumin, sodium azide (< 0.1%) and preservatives - The Solid Phase is a streptavidin coated paramagnetic microparticles in phosphate buffer with bovine serum albumin, sodium azide (< 0.1%) and preservatives - The Antigen Reagent is HAV antigen (~0.06 µg/mL) in tricine buffer with bovine serum albumin, stabilizers, sodium azide (< 0.1%) and preservatives Ancillary pack - The Ancillary Reagent is cysteine in citrate buffer with EDTA and preservatives HAVT Calibrators - Processed human plasma positive for anti-HAV antibodies with sodium azide (< 0.1%)

The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients. This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician. The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays. The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.

The LIAISON® XL Analyzer is an in vitro diagnostic device consisting of loading areas (for samples, Reagent Integrals, ancillary reagents, Starter Reagents, Cuvettes, Disposable Tips, water, Wash Buffer, maintenance liquid); incubator, wash station, reader, and a barcode reader for reagents and samples. Installation of the LIAISON® XL Workcell Upgrade Kit allows the LIAISON® XL Analyzer to be used with a compatible LAS and extends the sample pipetting capabilities to a point-in-space located external to the analyzer.

The ARCHITECT HAVAB-G assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection. Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection. Assay performance characteristics have not been established when the ARCHITECT HAVAB-G assay is used in conjunction with other hepatitis assays.

The ARCHITECT HAVAB-G assay determines the presence of IgG anti-HAV in human serum. After an acute HAV infection, IgG anti-HAV levels rise quickly and may persist for life. The presence of IgG anti-HAV implies past HAV infection (recent or distant) or vaccination against HAV. Detectable levels above the assay cut-off suggest immunity to HAV infection. The ARCHITECT HAVAB-G assay is a two-step immunoassay for the qualitative detection of IgG anti-HAV in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the first step, sample, assay diluent, and hepatitis A virus (human) coated paramagnetic microparticles are combined. IgG anti-HAV present in the sample binds to the hepatitis A virus (human) coated microparticles. After washing, the anti-human IgG acridinium-labeled conjugate that is added in the second step binds to IgG anti-HAV. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The presence or absence of IgG anti-HAV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-G calibration. Specimens with signal to cutoff (S/CO) values > 1.00 are considered reactive for IgG anti-HAV. Specimens with S/CO values < 1.00 are considered nonreactive.