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The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA) that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma assays into a ratio of pTau 217 to β-Amyloid 1-42 concentrations using the LUMIPULSE G1200 System. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer's disease. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is indicated for adult patients, aged 50 years and older, presenting at a specialized care setting with signs and symptoms of cognitive decline. A test result ≤ 0.00370 is a negative result which is consistent with patients who are unlikely to have amyloid pathology. These patients should be investigated for other causes of cognitive decline. A test result ≥ 0.00738 is a positive result which is consistent with patients who are likely to have amyloid pathology. This result does not establish a diagnosis of Alzheimer's disease or other cognitive disorders. A test result between 0.00371 and 0.00737 is an indeterminate result which is consistent with patients who are uncertain to have amyloid pathology. These patients should be considered for further testing. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio results must be interpreted in conjunction with other patient clinical information. This test is not intended as a screening or stand-alone diagnostic test.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is a test that combines the test results of the Lumipulse G pTau 217 Plasma assay and Lumipulse G β-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio from 0.00000 – 1.00000. The numerical ratio will be compared to the established cutoffs. Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio = Lumipulse G pTau 217 Plasma (results in pg/mL) / Lumipulse G β-Amyloid 1-42-N Plasma (results in pg/mL) = a numerical value targeted up to 1.00000. The Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma are assay systems including a set of immunoassay reagents for the quantitative measurement of pTau 217 and β-amyloid1-42, respectively, in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology. The LUMIPULSE G1200 is an instrument platform that can perform automated chemiluminescence immunoassays of specimens using LUMIPULSE G reagents. The LUMIPULSE G1200 reports the results of the two individual assays separately, and the ratio calculation must be done manually by the operator.

The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that combines the results of Lumipulse G B-Amyloid 1-42 and Lumipulse & B-Amyloid 1-40 assays into a ratio of ß-amyloid 1-42 to ß-amyloid 1-40 concentrations using the LUMIPULSE G 1200 System. The Lumipulse G B-Amyloid Ratio (1-42/1-40) is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. A test result ≥ 0.073 is a negative result which is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A test result ≤ 0.058 is a positive result which is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. A test result between 0.059 and 0.072 is considered as a likely positive result as it is more likely consistent with a positive amyloid PET scan result. A likely positive result does not establish a diagnosis of AD or other cognitive disorders and has increased uncertainty in regard to amyloid PET positivity. The Lumipulse G B-Amyloid Ratio (1-42/1-40) results must be interpreted in conjunction with other patient clinical information . This test is not intended as a screening or stand-alone diagnostic test.

The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that calculates the ratio of two analytes, Lumipulse G ß-Amyloid 1-42 and Lumipulse & ß-Amyloid 1-40 assays to generate a numeric value between 0.001 to 1.000. The test system consists of two component assays, Lumipulse & ß-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assay, running on LUMIPULSE G1200 system, and Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool to calculate the Lumipulse G B-Amyloid Ratio (1-42/1-40). Lumipulse G B-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assays are packed individually. Results of individual assays have not been assessed to support the intended use except for determination of the Lumipulse G ß-Amyloid Ratio (1-42/1-40).

Lumipulse G CA15-3 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA 15-3 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMPULSE G System. The assay is to be used as an aid in the management of patients previously diagnosed with stage II and III breast cancer. Serial testing for patient CA15-3 assay values should be used in conjunction with other clinical methods used for monitoring breast cancer. WARNING: The concentration of CA 15-3 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA 15-3 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used of CA 15-3 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse G CA 15-3 should not be used for cancer screening or diagnosis.

Lumipulse G CA15-3 is an assay system, including a set of immunoassay reagents, for the quantitative measurement of CA 15-3 in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. Lumipulse G CA15-3 Immunoreaction Cartridges: REF 235102 The Lumipulse G CA15-3 Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following: 1.) Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-CA 15-3 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15°C or lower. Preservative: sodium azide. 2.) Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.2 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-CA 15-3 monoclonal antibody (mouse), protein stabilizers (bovine and calf) and chemical stabilizers in 0.1 M sodium chloride/MES buffer. Preservative: sodium azide.

The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.

The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.

Lumipulse® G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA 19-9 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA 19-9 at some point in their disease process. Serial testing for patient CA 19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.

The Lumipulse G CA19-9-N Immunoreaction Cartridges (cat. # 235126) consists of 3 x 14 tests. Each kit contains the following: 1) Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µq/mL anti-CA19-9 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 ℃ or lower. Preservative: sodium azide. 2) Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-CA19-9 monoclonal antibody (mouse), protein stabilizers (bovine, calf, and mouse) and chemical stabilizers in 0.05 M sodium chloride/Bis-Tris buffer. Preservative: sodium azide.

For in vitro diagnostic use. Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following: 1) Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300 2) Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300

The Lumipulse G B•R•A•H•M•S PCT is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of PCT (procalcitonin) in human serum and plasma (sodium heparin, sodium citrate or dipotassium EDTA) on the LUMIPULSE G System. Used in conjunction with other laboratory findings and clinical assessments, Lumipulse G B.R.A.H.M.S PCT 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 (LRTI) - 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. Lumipulse G B.R.A.H.M.S PCT Calibrators set Lumipulse G B R A H M S PCT Calibrators set is for in vitro diagnostic use in the calibration of Lumipulse G B.R.A.H.M.S.PCT on the LUMIPULSE G System.

Lumipulse G B+R•A•H•M•S PCT is an assay system, including a set of immunoassay reagents, for the quantitative measurement of PCT in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G1200 System. Lumipulse G B.R.A.H.M.S PCT Immunoreaction Cartridges: | IRC 235058. The Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following: 1.) Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-PCT monoclonal antibody (mouse) and anti-calcitonin monoclonal antibody (mouse) coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15°C or lower. Preservative: sodium azide. 2.) Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.25 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-katacalcin monoclonal antibody (mouse), protein stabilizers (bovine, calf and mouse) and chemical stabilizers in 0.1 M sodium chloride/MES buffer. Preservative: sodium azide. Lumipulse G B+R+A+H+M+S PCT Calibrators set |CAL SET 234150, Lyophilized, 2 x 2 Concentrations Each calibrator kit contains one bottle each of Calibrators 1 - 2, and Reconstituting Solution. The calibrator kit is packaged separately. CAL 1 0 ng/mL PCT calibrator (2 x 0.5 mL/vial) CAL 2 100 ng/mL PCT calibrator (2 x 0.5 mL/vial) Contains procalcitonin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: ProClin 300. RS Reconstituting Solution: Liquid, 1 x 10 mL Preservative: sodium azide. These calibrators are lyophilized and have to be prepared by adding exactly 0.5 mL of Reconstituting Solution to each Iyophilized calibrator.

For in vitro diagnostic use. Lumipulse G TSH-III is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum on the LUMIPULSE G System. Lumipulse GTSHIII is to be used as an aid in the diagnosis of thyroid or pituitary disorders.

Lumipulse GTSH-III is an assay system, including a set of immunoassay reagents, for the quantitative measurement of TSH in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. TSH in specimens specifically binds to anti-human TSH monoclonal antibody (mouse) on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP: calf)-labeled anti-human TSH monoclonal antibody (mouse) specifically binds to TSH of the immunocomplexes on the particles, and additional immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Substrate Solution is added and mixed with the particles. AMPPD contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects the amount of TSH.

Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.

Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL. Lumipulse® G FSH-N Calibrators: Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following: CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.

Lumipulse G Progesterone-N Calibrator kit contains 3 bottles (1.5 mL each) of Lumipulse G Progesterone-N Calibrators 1, 2, and 3. Calibrators 1, 2, and 3 contain progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide. Lumipulse G Progesterone-N Calibrators CAL 230893, Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately. CAL 1 0 ng/mL Progesterone calibrator (1 × 1.5 mL) CAL 2 0.5 ng/mL Progesterone calibrator (1 x 1.5 mL) 40 ng/mL Progesterone calibrator (1 x 1.5 mL) CAL 3 *Contains progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.