Assays

Reproductive disease test

Beckman CoulterThe 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

DRG InternationalThe 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

Diagnostic HYBRIDSThe 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

Beckman CoulterGentian 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

Beckman CoulterA 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

ProdesseProGastro 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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