Assays
Reproductive disease test
The Access Sex Hormone Binding Globulin (SHBG) assay
is for use in the differential diagnosis of conditions of chronic or excessive androgenic activity. The assay may also be used in conjunction with the Access testosterone assay to provide a calculated free androgen index. SHBG is responsible for the transport of testosterone and estradiol in the blood. Less than 2% of sex hormones are free, with the remainder bound with high affinity to SHBG and low affinity to albumin. The binding of sex hormones to SHBG inhibits their function; therefore, bioavailability of sex hormones is influenced by the level of SHBG.
Beckman Coulter
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Diagnostic kit measures hormone Hepcidin
The
enzyme-linked immunosorbant assay DRG Hepcidin 25 (C-Terminal) ELISA
Kit offers a fast and accurate method to test patient Hepcidin
levels. The measurement results can offer more information to clinicians
to help diagnose and treat medical conditions including iron-deficiency
diseases. Hepcidin helps regulate the amount of iron in humans.
Unbalanced iron levels can lead to common medical conditions including
anemia, chronic kidney disease, and iron-overload diseases.
DRG International
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Detection of thyroid-stimulating immunoglobulins
The
Thyretain TSI Reporter BioAssay is an
in vitro diagnostic-use test that specifically detects
thyroid-stimulating immunoglobulins (TSI) in patient serum. The test is
used as an aid in the differential diagnosis of Graves’ disease.
Thyretain provides laboratories with the ability to test for TSI using
standard laboratory equipment, does not require the use of
radioactivity; and eliminates any ambiguity of test results that can be
confounded by the presence of non-TSI auto-antibodies. The kit includes
a genetically engineered cell line that produces the reporter enzyme
luciferase in response to specific TSI binding, and the amount of
luciferase produced is then rapidly detected using a luminometer.
Diagnostic HYBRIDS
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Early detection of renal failure
Gentian
Cystatin C Immunoassay (CYSX) is an assay for the quantitative
determination of cystatin C in human serum and plasma. When used on the
company’s Synchron and UniCel Clinical Systems, Gentian CYSX can be used
in the diagnosis and treatment of renal disease. Reagents and
calibrators for the assay are liquid and ready to use, eliminating the
need for mixing, hydrating, or pre-diluting before testing. A number of
studies report that cystatin C assays are sensitive. Cystatin C is an
early indicator of decreased renal function and may be a superior marker
over creatinine in the estimation of glomerular filtration rate, or GFR,
the overall index of kidney function.
Beckman Coulter
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Oxycodone assay added to DOA menu
A
new DRI Oxycodone Enzyme Immunoassay (OXYX) assay for the
qualitative and semi-quantitative determination of oxycodone and its
metabolite oxymorphone in human urine is available. Reagents and
calibrators for the DRI oxycodone assay are liquid and ready-to-use,
which eliminates the need for mixing, hydrating, or pre-diluting
reagents before testing. Drugs of abuse (DOA) test assays available
through this company are formulated and packaged to provide the critical
elements of effective DOA analysis — speed, accuracy, ease of use, and
economy. In conjunction with Synchron and UniCel Clinical Chemistry
Systems, these assays provide timely, reliable, and efficient DOA
results.
Beckman Coulter
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C diff results in as little as three hours
ProGastro
Cd Assay for detection of Clostridium difficile uses
real-time PCR (polymerse chain reaction) technology, is simple to use,
and easily intergrates into existing lab workflow. The product has been
optimized for the use of automated extraction technology, so its
inhibition rate is extremely low. A result can be obtained in as little
as three hours using the assay. In clinical trials, ProGastro Cd
detected 43% more positives than the current gold standard. Genetic
sequencing confirmed that more than 90% of the additional positives
detected by Pro-Gastro Cd were accurate.
Prodesse
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New reagent app for determining of HDL cholesterol
A
new user-defined application is available for the quantitative
determination of HDL cholesterol on the UniCel DxC 600 Synchron
analyzer. The Liquid autoHDL Cholesterol Assay is a homogeneous
two-reagent method for directly measuring serum HDL-C levels without the
need for offline pretreatment. The first reagent contains a-cyclodextrin
and dextran sulfate to stabilize LDL-C, VLDL, and chylomicrons. The
second reagent contains PEG-modified enzymes that selectively react with
the cholesterol present in the HDL particles. Consequently, only the HDL
cholesterol is subject to cholesterol measurement. The liquid autoHLD
cholesterol reagent is a linear from 2 mg/dL to 150 mg/dL.
Pointe Scientific
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Automated assay for anemia diagnosis, treatment
Access
sTfR Assay and the sTfR/Log Ferritin Index (sTfR Index) are
used as an aid in the diagnosis of iron-deficiency anemia, and
the differential diagnosis of that and anemia of chronic
disease. The automated assay, used in combination with the sTfR
Index, which is calculated on board the Access and UniCel DxI
instruments marketed by this company, produces a recommended
cutoff that can indicate the nature of a patient’s anemia. The
assay and the sTfR Index also help in the treatment especially
of chronically ill patients. Together, the Access sTfR Assay and
sTfR Index are new and important tools that aid in the diagnosis
and simplify the complex etiology of anemia.
Beckman Coulter
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Graves’ disease assay with TAT of only 27 minutes
The
Anti-TSHR Assay is the only fully automated TSH receptor antibody (TRAb)
available for use on the cobas e 601 and 411 analyzers, MODULAR
ANALYTICS E 170 module, and Elecsys 2010 system. Used in the
determination of Graves’ disease, as well as monitoring therapy and
aiding in prediction relapse, this assay has a turnaround time of only
27 minutes and can be run with other thyroid tests utilizing one sample
tube — giving greater efficiency in processing traditional and novel
thyroid markers. Anti-TSHR delivers patient results more than two hours
faster than other assays, helping to free up other lab personnel for
other tasks.
Roche Diagnostics
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Control assayed for many new instruments
The
Cell-Chex Auto, the first body-fluid control for automated
body-fluid analysis, is now assayed for the XE-5000. It is also assayed
for use of the Sysmex XE-2100, XT-1800i, XT-2000i, Abbott CELL-DYN 3200,
CELL-DYN 4000, Sapphire, Ruby, and Beckman Coulter LH 750/LH 755 and LH
78 (levels 2 and 3) instruments. Cell-Chex-Auto verifies the accuracy of
the lower RBC and WBC limits of the instruments’ reportable range. It
also allows lab techs to test limits for their instruments lower than
their daily CBC testing would verify. Available in 3.0-mL plastic cap-pierceable
vials, this product has closed-vial stability of 75 days and open-vial
stability for 30 days.
Streck
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Assess risk for CAD, ischemic stroke
The
PLAC Test is the only blood test cleared by the FDA to aid in
assessing risk for both coronary-artery disease (CAD) and ischemic
stroke. The test measures levels of Lp-PLA2, a cardiovascular-specific
inflammatory enzyme, that is carried to the walls of the arteries by
LDL, the “bad cholesterol.” The PLAC Test should be used as an adjunct
in persons assessed to be at moderate or high cardiovascular risk by
traditional factor assessment. The test is available in ELISA formats or
in an automated format. Two highly specific monoclonal antibodies are
used in the assay, and it is calibrated to a well-characterized
recombinant Lp-PLA2 standard to increase accuracy of the test.
diaDexus
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Type-specific assay
The
FDA has recently cleared the
AtheNA Multi-Lyte HSV 1&2 IgG Plus Test System, a
herpes simplex virus (HSV) type-specific assay, for use on the
AtheNA Multi-Lyte System. The new assay is intended for the
qualitative detection of IgG antibodies to two separate
antigens; HSV-1 and HSV-2 in human serum. The assay uses
recombinant glycoprotein G (gG), a known HSV agent that binds
with type-specific HSV antibodies. It simultaneously performs
multiple assays from a single sample in one well, offering a
streamlined alternative to IFA, immunoblot and ELISA testing.
Inverness Medical
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Real-time PCR for quick results
The
Clostridium difficile assay is a qualitative in
vitro diagnostic test for the rapid detection of the C
diff toxin B gene (tcdB) in human-liquid or soft-stool
specimens from patients suspected of having C diff
infection. The test, based on real-time PCR, is intended for use
as an aid in its diagnosis. Quickly finding a definitive
diagnosis means patients get proper treatment immediately or can
be placed in isolation sooner to reduce transmission and prevent
outbreaks. This helps reduce inappropriate antimicrobial use in
negative patients.
BD GeneOhm
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Addition to test menu
An
Automated Direct Whole Blood HbA1C Assay is now available
for the BioLis 24i benchtop chemistry analyzer. With this direct
method, the whole blood sample is loaded onto the BioLis 24i,
which automatically dilutes, lyses, and analyzes the specimen.
Direct HbA1C throughput on the analyzer is 240 tests per hour.
and tests do not have to be run in batch mode. This liquid
ready-to-use reagent is National Glycohemoglobin Standardization
Program (NGSP) approved, stable on board for 30 days, and has
calibration stability of 14 days. The addition of HbA1C enhances
the BioLis 24i as a special chemistry analyzer by adding to its
comprehensive 100 test menu.
Carolina Liquid Chemistries
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One-step pregnancy assay
The
WH Accu Test is a rapid qualitative one-step assay for detection of
hCG in urine to ascertain pregnancy. The method employs a combination of
monoclonal dye conjugate and polyclonal slide phase antibodies to
selectively identify the hCG in the test samples with an extremely high
degree of sensitivity. In less than five minutes, levels as low as 25
mLU/mL can be detected. Each test strip is individually sealed in a foil
pouch with a desiccant inside. Foil pouch strips can be stored at room
temperature. Period of expiration is 18 months; results can easily be
read in three minutes with accuracy of more than 99%.
Hemosure
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Diagnose acute or recent infection
The
VITROS Cytomegalovirus (CMV) IgM Assay will aid in the
diagnosis of an acute or recent infection with this virus belonging to
the herpes group. CMV infections are most significant during pregnancy;
they are associated with newborns’ congenital defects. This assay gives
critical information to physicians caring for pregnant women and is
performed on the VITROS ECi/ECiQ Immunodiagnostic System using
Intellicheck technology. The lab can run patient samples in continuous
random-access mode 24/7 and have confidence in result reporting.
Ortho-Clinical Diagnostics
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Monitor renal function
FDA
clearance has been granted for the sensitive and specific
Cystatin C Assay for use on Roche’s Modular Analytics <P>. This
assay is an accurate marker of glomerular- filtration rate and is
reliable for monitoring renal function. This assay utilizes calibrators
and controls manufactured from human serum. The kit includes 100 tests,
including a latex-enhanced reagent for high sensitivity, a set of six
ready-to-use calibrators, and high- and low-control sera. Other benefits
include liquid stable reagents with long shelf life, complete kit in a
ready-to-use format, with a rapid, fully automated method, and detailed
instrument parameter information.
The Binding Site
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