Assays
Rapid thyroid stimulating hormone screen
Designed to be an initial screening device to aid in the diagnosis of hypothyroidism, the CLIA-waived ThyroTest is a rapid thyroid-stimulating hormone (TSH) test used for symptomatic patients. This test screens patients with symptoms of hypothyroidism by measuring the level of TSH, yielding a positive result if the level of TSH is higher than 5 µIU/mL; the standard for the upper limits of normal for TSH. Using two drops of blood from a fi ngerstick and fi ve drops of diluent, a qualitative TSH level is indicated in 10 minutes. Positive results indicate a patient’s abnormally high level but does not give an quantitative value. The TSH test also includes controls.
ThyroTec
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Automated HIV antibody test
The OCD VITROS Anti-HIV 1+2 Assay for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems, is an in vitro diagnostic immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma, providing results in less than 50 minutes. The systems’ random-access and automated features allow tests to be run at any time and in any order as needed, eliminating the need for expensive batch testing of multiple patient samples. Each kit includes 100 tests and has a shelf life of the 44 weeks. The VITROS 5600 System offers a complete infectious disease testing menu, including Anti-HIV 1+2 and rubella.
Ortho Clinical Diagnostics
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Assess response to antiplatelet medication
The VerifyNow P2Y12 Assay is a whole-blood assay used in the lab or point-of-care setting to measure the level of platelet P2Y12 receptor blockade. The test uses ADP as an agonist to induce platelet activation and ascertain the level of platelet reactivity due to thienopyridines. Utilizing an automated analyzer with single-use, disposable assays, the system can also help assess patient response to other antiplatelet medications such as aspirin, clopidogrel, prasugel, and GP IIb/IIIa inhibitors. The system provides results in less than five minutes for most assays. The system is also equipped with internal assay controls, electronic quality control testing, and two levels of wet quality controls to ensure the instrument and assays are performing as expected.
Accumetrics
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Hepcidin hormone testing kit
The Hepcidin 25 (C-Terminal) ELISA Kit measures the hormone hepcidin to quickly diagnose iron disorders, including hemochromatosis and anemia. In recent years, scientists discovered that hepcidin helps regulate the amount of iron in humans. Unbalanced iron levels can lead to many common medical conditions including anemia and iron-overload diseases. Unbalanced iron levels also can occur in chronic kidney disease, inflammation, or diabetes mellitus. The measurement results will offer information to clinicians to help diagnose and treat conditions including iron-deficiency diseases.
DRG International
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Molecular diagnostic MRSA test
NucliSENS EasyQ MRSA, an automated test for methicillin-resistant Staphylococcus aureus (MRSA) for the NucliSENS system, detects seven MRSA types, covering the most prevalent S aureus strains (MREJ types 1, 2, 3, 4, 5, 7, and 12). The simultaneous detection of two targets, reducing the risk of a false-positive result, improves its specificity and avoids re-testing, inappropriate antibiotic treatment, and isolation of patients. The test provides rapid results, with a turnaround time of less than three hours, and the flexibility of being used for batch (46 tests) or stand-alone (one test) screening.
bioMérieux
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Fetal maternal hemorrhage screening test
FETALSCREEN II Fetal Maternal Hemorrhage Screening Test is a simple, qualitative test that detects D (Rho) positive fetal red-blood cells in the maternal circulation of pregnant Rh-negative women for the detection, prevention, and management of hemolytic disease of the newborn (HDN), a serious autoimmune disease caused by incompatibility between the mother’s and baby’s blood. The test uses an innovative blend of monoclonal antibodies for stability and accuracy; enzyme-treated indicator cells to facilitate robust reactivity and results clarity; and fewer microscopic fields to simplify results reading and interpretation.
Ortho Clinical Diagnostics
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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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