Clinical Chemistry Control Reagents
calibration standards, reference standards,
usp reference standards, clinical chemistry controls, hematology controls, diagnostic
controls, toxicology controls
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Clinical Chemistry product
line offers an array of critical raw materials (intermediates) and finished reagents to
diagnostic manufacturers and clinical laboratories. ISO 9001 certified and manufactured in
cGMP facilities.
Direct Amylase
Lipase Color
Liquid HDL
Liquid HDL
Cholesterol Calibrator
HDL
Linearity Verifiers
LDL
Cholesterol Calibrator
LDL
Linearity Verifiers
LDL
wrCRP
Direct
Amylase
Product Overview:
Direct Amylase is a
fully automated single liquid reagent for the measurement of Amylase in the clinical
chemistry laboratory. Measurement of Amylase, in conjunction with Lipase, is used in the
diagnosis of acute pancreatitis.
Key Assay
Attributes:
| Single liquid reagent with 2
year stability |
| Direct CNPG3 Substrate
requiring no coupling enzymes |
| No lag phase |
| Linearity to 20 times the
upper reference range |
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Lipase
Color
Product Overview:
Lipase Color is a
fully automated colorimetric reagent for the measurement of lipase in the clinical
chemistry laboratory. Measurement of lipase, in conjunction with Amylase, is used in the
diagnosis of acute pancreatitis.
Key Assay
Attributes:
| Simple kinetic colorimetric
assay requiring no sample blank |
| Specific for pancreatic
lipase |
| No interference from
pancreatic cholesterase, hepatic lipase or lipoprotein lipase |
| More accurate than
turbidimetric |
| Linearity to 750 U/L |
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Liquid HDL
Product Overview:
HDL is a liquid,
two-reagent homogeneous method for the direct measurement of HDL cholesterol. The method
is completely automated on most clinical chemistry analyzers, and does not require any
off-line pretreatment, centrifugation or reagent reconstitution steps.
Key Assay
Attributes:
| Easy to use assay |
| Ready to use, stable liquid
reagents with no reagent preparation |
| Works with fasting and
non-fasting patient samples |
| Linear Between 3.7 and 200
mg/dL |
| No significant interference
from elevated levels of ascorbic acid, bilirubin, hemoglobin, triglycerides or
gamma-globulins |
| Calibrator traceable to the
CDC reference method for cholesterol (NRS/Chol) |
| Precision exceeds the 1998
NCEP goals |
| Excellent correlation to the
reference method |
| Performance exceeds the 1998
NCEP HDL cholesterol total error goals |
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Liquid HDL Cholesterol Calibrator
Product Overview:
For the calibration
of the Liquid HDL Cholesterol assay in serum or plasma.
Key Assay
Attributes:
| Unopened calibrator is stable
at 2-8 degrees C until the expiration date printed on the vial |
| After reconstitution,
calibrator is stable for 7 days at 2-8 degrees C |
| Reconstitution stability of
the calibrator may be extended by aliquoting and freezing the reconstituted calibrator
preparation at -20 degrees C or -70 degrees C for up to 4 weeks |
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HDL Linearity
Verifiers
Product Overview:
To perform linearity
testing to verify the reportable range of the Liquid HDL Cholesterol assay.
Key Assay
Attributes:
| HDL Linearity Verifiers
challenge the broad reportable range of HDL reagent |
| Results in fewer patient
sample dilutions |
| Helps your laboratory gain
efficiency through increased through-put |
| Improves turn around time |
| HDL Linearity Verifiers
enable your laboratory to meet CLIA and regulatory requirements |
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LDL Cholesterol
Calibrator
Product Overview:
For the calibration
of the LDL Cholesterol assay in serum or plasma.
Key Assay
Attributes:
| Unopened calibrator is stable
at 2-8T C until the expiration date printed on the vial |
| After reconstitution,
calibrator is stable for 2 weeks at 2-8T C |
| The reconstituted calibrator
may be aliqoted and stored at -80T C |
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LDL Linearity Verifiers
Product Overview:
To perform linearity
testing to verify the reportable range of the LDL Cholesterol assay.
Key Assay
Attributes:
| LDL Linearity Verifiers
challenge the broad reportable range of LDL reagent |
| Results in fewer patient
sample dilutions |
| Helps your laboratory gain
efficiency through increased through-put |
| Improves turn around time |
| LDL Linearity Verifiers
enable your laboratory to meet CLIA and regulatory requirements |
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LDL
Product Overview:
LDL is a liquid, two reagent homogeneous method for the direct measurement of LDL
cholesterol. The method is completely automated and applicable to most clinical chemistry
analyzers, and does not require any off-line sample pretreatment, centrifugation or
reagent reconstitution steps. As a fully automated reagent system LDL has revolutionized
routine LDL cholesterol testing, enabling laboratories to realize significant operational
benefits while at the same time improving the quality of LDL cholesterol results.
Key Assay
Attributes:
| Easy to use assay eliminates
all sample pretreatment |
| Ready to use stable, liquid
reagents with no reagent preparation |
| Works with fasting and
non-fasting patient samples |
| Linear between 6.6 and 992
mg/dL |
| No interferences with
triglycerides up to 1,200 mg/dL |
| Calibrator traceable to the
CDC reference method for cholesterol (NRS/Chol) |
| Precision exceeds the 1998
NCEP goals for accuracy |
| Excellent correlation to the
reference method |
| Performance exceeds the 1998
NCEP LDL cholesterol total error goals |
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wrCRP
Product Overview:
wrCRP is an enhanced
latex-agglutination turbidimetric immunoassay. Sample is added to the buffer solution and
mixed with a suspension of mouse anti-human CRP monoclonal antibody that is bound to
latex. CRP binds to the latex-bound antibody and agglutinates. The light scattering caused
by the increase in particle size is used as a measure of CRP concentration. The amount of
light scattering is proportional to the concentration of CRP in the sample.
Key Assay
Attributes:
| High Sensitivity - To measure
very low concentrations. |
| Precision satisfies AHA and
CDC recommendations for high sensitive method (CVs of <10% at levels of 0.3 mg/L to 10
mg/L CRP - A highly reproducible assay adds to the reliability of measurement. |
| Wide measurable range - To
cover the clinically useful range with a single reagent. |
| No need for sample dilution
up to 320 mg/L - Saves repeating a |
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