HSV-1 and HSV-2 Tests

Efficient, type-specific HSV testing

Roche Diagnostics Corp, Indianapolis, has received FDA clearance for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The immunoassays are intended for use with Roche’s electrochemiluminescence (ECL) technology, a highly sensitive light-detection system that provides low-end sensitivity and broad dynamic measuring ranges. The tests are approved for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602, and Modular Analytics E170 analyzers.

Roche Diagnostics Corp
(800) 428-5074
www.roche-diagnostics.us

Blood Test to Rule Out Obstructive Coronary Artery Disease

Gender differences taken into account

Corus CAD, from CardioDx Inc, Palo Alto, Calif, can help primary care clinicians and cardiologists exclude obstructive coronary artery disease as the cause of a stable nondiabetic patient’s symptoms. It accounts for critical biological differences between men and women. The Corus CAD test measures the RNA levels of 23 genes. Because peripheral blood cell RNA levels are altered when obstructive coronary artery disease is present, the Corus CAD score aids clinicians in assessing whether an individual patient’s symptoms might be due to obstructive coronary artery disease.

CardioDx Inc
(650) 475-2788
www.cardiodx.com

Chagas Assay

Test kit detects circulating antibodies

Adept Immunodiagnostics LLC has released its Hemagen Virgo® Chagas IgG ELISA Assay. The kit is specifically designed to detect circulating antibodies to Trypanosoma cruzi, the causative agent of Chagas’ disease (American Trypanosomiasis). During an initial incubation step, Chagas antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a washing step. A second antibody, conjugated to the enzyme horseradish peroxidase, recognizes human IgG and binds to the patient’s antibodies remaining from the first step. Following a wash step, in wells where the conjugate remains bound, the enzyme then catalyzes a color change in the substrate. After the enzymatic reaction is stopped, the result is measured on an EIA Plate reader at 450 nm.

Adept Immunodiagnostics LLC
(215) 375-0669

Credit-Card-Size Agglutination Product

A 2-minute test determines abo blood group and RH factor

Micronics Inc, Redmond, Wash, introduces the ABORhCard®, a qualitative in vitro agglutination test for the simultaneous determination of ABO blood group and Rh factor status in approximately 2 minutes from a fingerstick of whole blood. The credit-card-size device is FDA 510(k) cleared for educational and informational purposes; it is not for use in blood bank processing of blood products, for determining RHD status for the purpose of administration of Rh immunoglobulin, or for screening purposes prior to transfusion. No instrument/equipment or refrigeration is required. Additional features include long shelf life and waste containment in the card itself for easy disposal.

Micronics
(425) 895-9197
www.micronics.net

Testosterone Assay

Measures levels to help diagnose related conditions in males and females

Abbott, Abbott Park, Ill, has received CE marking for its ARCHITECT 2nd Generation Testosterone Assay, with improved sensitivity and clinical utility. With a simple blood test, the assay can accurately measure the wide range of testosterone levels seen in a number of different patient populations and clinical settings. The company has filed a submission for FDA 510(k) clearance. The measurement of testosterone plays a role in the diagnosis and treatment of many conditions in males and females of all ages. Published studies have shown that many currently available testosterone assays are not sensitive enough to measure low levels of testosterone, the company says. The new assay runs on Abbott’s fully automated ARCHITECT family of analyzers.

Abbott
(847) 937-6100
www.Abbott.com

Performance Panels for Diagnostic Tests

For HCV and human T-lymphotropic virus

SeraCare Life Sciences, Milford, Mass, introduces its third Worldwide HCV RNA Performance Panel and eighth Anti-HTLV I/II Mixed Titer Performance Panel assays for quality assurance.The Worldwide HCV RNA Performance Panel is a panel of samples collected from HCV-infected individuals in regions around the world where less common HCV genotypes predominate. The panel includes samples of most of the known genotypes, including the hard-to-source genotypes 5 and 6. The SeraCare Anti-HTLV I/II Mixed Titer Performance Panel contains 21 undiluted, naturally occurring plasma samples collected from different individuals who tested positive for antibodies to Human T-Lymphotropic virus. With a range of reactivities from negative to strongly positive for anti-HTLV, the panel provides samples to challenge assays for anti-HTLV I, II or I/II and includes results from five anti-HTLV screening tests as well as three confirmatory methods.

SeraCare Life Sciences
(800) 676-1881
www.seracarecatalog.com

CMV Test

For use on cobas system

Roche, Indianapolis, introduces a new test to assess a patient’s viral load of cytomegalovirus (CMV). Physicians use information from the test to help them manage patients who have been diagnosed with CMV disease; specifically, patients with an immune system that has been suppressed for solid organ transplantation. The test received premarket approval from the FDA in July. The real-time polymerase chain reaction (PCR)-based CMV test provides standardization of CMV viral load monitoring with traceability to the WHO International CMV standard. It is designed for use on Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan System, an established platform for viral load monitoring of multiple infectious diseases. The system can be combined with the cobas p 630 Instrument, which provides an integrated preanalytical primary tube-handling solution.

Roche
(317) 521-2000
www.roche.com

CH50 Assay

Fully automated, FDA-cleared

The Binding Site Inc, San Diego, CH50 assay on the SPAPLUS is an FDA-cleared, fully automated assay for measuring total complement activity (CH50) by directly testing the function of the resulting end product of the complement cascade, the Membrane Attack Complex (MAC). The company offers a full suite of fully automated serum protein diagnostic assays to physicians and laboratory professionals globally. CH50 is the latest addition to its panel of complement assays: C3c, C4, IgG, IgA, IgM, and IgG and IgA subclasses.

The Binding Site Inc
(800) 633-4484
www.thebindingsite.com