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The ARCHITECT B R A H M S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem. Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT BR A-H-M-S PCT assay is intended for use as an: · Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock. · Aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time. · Aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRT) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) - in an inpatient setting or an emergency department. · Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. The ARCHITECT B R A H M S PCT Calibrators are for the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only. The ARCHITECT B-R-A-H-M-S PCT Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.

The ARCHITECT B.R.A.H.M.S PCT assay reagents are available in 100 or 500 test kits. The kit components include PCT Microparticles coated with Rat monoclonal anti-PCT and PCT Conjugate with Mouse monoclonal anti-PCT acridinium-labeled conjugate. Both contain Bovine serum albumin and preservatives. The ARCHITECT B.R.A.H.M.S PCT Calibrators kit consists of 6 bottles, with Calibrator A containing normal human plasma and Calibrators B-F containing recombinant human PCT in phosphate buffer. The ARCHITECT B.R.A.H.M.S PCT Controls kit consists of 2 x 3 bottles at three target concentrations of recombinant PCT in phosphate buffer. The assay is a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology.

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI). ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).

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ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease. The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serion and plasma. The ARCHITECT® Anti-TPO Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument), when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human ser im and plasma.

The ARCHITECT Anti-TPO assay is a two-step immunoassay for the quantitative determination of anti-TPO in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Cherriflex® In the first step, sample, assay diluent and TPO coated paramagnetic microparticles are combined and incubated. Anti-TPO present in the sample binds to the TPO coated microparticles. After washing, anti-human IGG acridinium labeled conjugate is added in the second step. Following and wash, herearinger and trigger solutions are added to the reaction mixture. The resulting chemiluminessent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-TPO in the samble and the RLUs detected by the ARCHITECT i system optics.

ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease. The ARCHITECT® Anti-Tg Calibration of the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma. The ARCHITECT® Anti-Tg Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument) when used for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.

The ARCHITECT Anti-Tg assay is a two-step immunoassay for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent and Tg coated paramagnetic microparticles are combined and incubated. Anti-Tg present in the sample binds to the Tg coated microparticles. After washing, anti-human IgG acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-Tg in the sample and the RLUs detected by the ARCHITECT i system optics.

ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI). The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.

The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI). The ARCHITECT STAT Troponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.

The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read relative to a standard curve established with calibrators of known troponin-l concentration.

ARCHITECT STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.

The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen. The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions. The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

Pacific Hemostasis Reference Emulsion is intended to be used on Instrumentation Laboratories ACL system.

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