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The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer. The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.

The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, 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 therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.

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 LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer. The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay. The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples. LIAISON® N-TACT® PTH Gen II Control set contains: 2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL. The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set. LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains: 4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL. The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.

The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer. During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase. 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, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.

The LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA and Lithium heparin plasma. The LIAISON® 25 TOTAL-D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The DiaSorin LIAISON® 25 TOTAL-D is intended to be used on the LIAISON® XL Analyzer. The DiaSorin LIAISON® 25 TOTAL-D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 TOTAL-D assay. The DiaSorin LIAISON® 25 TOTAL-D Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® 25 TOTAL-D assay when performed on the LIAISON® XL Analyzer.

The LIAISON® 25 TOTAL-D consists of one Reagent Intergral with calibrators, which consists of: Magnetic Particles (2.4 mL) coated with goat antibody against 25 OH Vitamin D, protein, phosphate buffer, < 0.1% sodium azide. Assay Buffer (28.0 mL) with 7.5% ethanol, surfactants and 0.2% ProClin® as a preservative. Conjugate (4.5 mL) 25 OH Vitamin D conjugated to an isoluminol derivative. in phosphate buffer with10% ethanol, EDTA and 0.1% benzoic acid as a preservative. Calibrator 1 (1.2 mL) Human serum, BSA, <0.1% sodium azide and 25 OH Vitamin D. The calibrator concentrations (ng/mL) are referenced to standard preparations containing highly purified 25 OH Vitamin D. Calibrator 2 (1.2 mL) Human serum, BSA, <0.1% sodium azide and 25 OH Vitamin D. The calibrator concentrations (ng/mL) are referenced to standard preparations containing highly purified 25 OH Vitamin D. The LIAISON® 25 TOTAL-D control consists of 2 levels of human serum, BSA, <0.1% sodium azide and 25 OH Vitamin D. The LIAISON® 25 TOTAL-D calibration verifier consists of 4 levels of human serum, BSA. <0.1% sodium azide and 25 OH Vitamin D.

The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.

The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Toxoplasma gondii and a conjugate of mouse monoclonal antibodies to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Toxoplasma gondii antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjuqate reacts with anti-Toxo IgG that is already bound to the solid phase. After each incubation, 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 therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-Toxo IqG in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.

The LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum samples. It is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended that the LIAISON® Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. The LIAISON Control Toxo IgM II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON Toxo IgM II assay on the LIAISON® XL Analyzer.

The method for qualitative determination of specific IgM to Toxoplasma gondii is an antibody capture chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with IgG (mouse, monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgM, Toxoplasma gondii antigen, and a conjugate of mouse monoclonal antibodies to Toxoplasma gondii linked to an isoluminol derivative (isoluminol-antibody coniugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the mouse monoclonal antibody conjugate reacts with Toxoplasma gondii antigen and the immune complex thus formed reacts with IgM already bound to the solid phase. After the incubations, 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 Toxoplasma gondii IgM concentration present in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.

The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.

The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay. The method for the quantitative determination of TSH is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to TSH concentration present in calibrators, patient samples or controls. The LIAISON® Control Thyroid 1, 2 and 3 are prepared from human serum at target values of 0.5-0.78 mIU/L. 7.0-9.48 mIU/L and 42.7-57.7 mIU/L.

The DiaSorin LIAISON® FT4 assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of free thyroxine (FT4) in human serum using the LIAISON® Analyzer. It is intended for use as an aid in the clinical assessment of thyroid status. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® FT4 assay.

The DiaSorin LIAISON® FT4 assay's method for quantitative determination of FT4 is based on the Solid Phase Antigen Linked Technique (SPALT) principle. A T4-protein-conjugate is coated on the magnetic particles (solid phase); a monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® Analyzer. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to FT4 concentration present in calibrators, patient samples or controls.

The DiaSorin LIAISON® Testosterone assay is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON®Analyzer. The assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in male subjects and, in female subjects hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes. The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassay.

The LIAISON® Testosterone assay's method for quantitative determination of testosterone is a direct, competitive, chemiluminescence immunoassay (CLIA). Specific antibody to testosterone is bound to magnetic particles (solid phase) and testosterone is linked to an isoluminol derivative. During the incubation, testosterone is dissociated from its binding protein and competes with labeled testosterone for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of testosterone present in calibrators, controls, or samples. All assay steps and incubations are performed by the LIAISON® Analvzer. Two point kit calibrators are used to establish specific working curves based on assay master curves stored on the Analyzer. The LIAISON® Testosterone reagent kit consists of a reagent intrgral which contains antibody coated magnetic particles (2.3 mL), conjugate (12 mL) and assay buffer (12 mL) reagents. Two levels of ready to use calibrators (2 vials each level, 2.0 mL per vial) are provided with each kit. Each kit consists of 100 tests.