Search Results

FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

The FastPack® IP Sex Hormone Binding Globulin Immunoassay employs a sandwich immunoassay principle. Endogenous SHBG in a patient sample, calibrator, or control is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-SHBG antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-SHBG antibody linked to biotin will bind to streptavidin coated paramagnetic particles (PMP). After incubation, washing steps (using a Tris buffer containing detergents) occur to separate bound from unbound anti-SHBG monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of SHBG in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use. FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle. Endogenous CRP in a patient sample, calibrator, control, or verifier is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-CRP antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-CRP antibody linked to biotin. After incubation, immunoreacted complex (Monoclonal anti-CRP antibody-ALP conjugate and anti-CRP antibody linked to biotin reacted with CRP in the sample) is mixed with streptavidin coated paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-CRP monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N'-dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield Nmethylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of CRP in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer. FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer. FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer. FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.

The FastPack® Vitamin D Immunoassay employs a competitive immunoassay principle. Endogenous Vitamin D in a patient sample, calibrator, control, or verifier is mixed with pretreatment buffer then added into a FastPack® reagent pack. In the reagent pack, the pre-treated Vitamin D sample binds with a monoclonal (mouse) anti-Vitamin D antibody covalently linked to alkaline phosphatase (ALP). After incubation, a conjugate of Vitamin D-Biotin linked to streptavidin coated paramagnetic particles is added. Monoclonal anti-Vitamin D antibody-ALP conjugate not reacted with Vitamin D in the sample will bind to unoccupied binding sites of the Vitamin D-biotin conjugate bound to the streptavidin paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-Vitamin D monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N.Ndimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are inversely proportional to the concentration of Vitamin D in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

The FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert: - Free Thyroxine (FT4) - Human Chorionic Gonadotropin (hCG) - Testosterone - Total Prostate Specific Antigen (tPSA) - Thyroid Stimulating Hormone (TSH)

FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin. The control is provided in liquid form for convenience.

The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma. The FastPack® Testo Immunoassay is designed for use with the FastPack® System. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer. The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components: Paramagnetic Particles, Testosterone Antibody Solution, Wash Buffer, and Substrate. The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.

The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Not Found

The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

The FastPack® PSA Method Verification Kit The FastPack® Total PSA Method Verification kit components are in liquid form, in vials, from which the user can directly remove sample. They are formulated at three (3) levels packaged together as a kit.

The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System. The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma. The FastPack ® Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma.

The FastPack® TSH Immunoassay is a competitive chemiluminescence assay. - . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C. - . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C. - . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials. - Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C. - The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of TSH in human plasma.

The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay. ● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C. - . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C. - . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials. - . Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.