Test Detects Bath Salts
Lab-created versions of a controlled substance
Ameritox, Baltimore, has developed a test to detect bath salts, a class of drugs being created in chemistry labs with the purpose of bypassing laws and providing a “legal high.” Although the Drug Enforcement Administration currently includes three synthetic cathinones on its list of banned Schedule 1 drugs, Ameritox scientists have formulated tests that screen for five additional chemical compositions. Structurally and pharmacologically similar to amphetamine, methamphetamine, and MDMA (“Ecstasy”), synthetic cathinones, or bath salts, are laboratory-created versions of a controlled substance. These substances, however, have no legitimate bathing use, in contrast to Epsom salts. New versions of bath salts are continuously produced with a slightly altered molecular structure to avoid being classified as illicit drugs.
Ameritox
(877) 596-2224
www.ameritox.com
New Molecular Assay
Simplify active surveillance testing for deadly superbug
BD Diagnostics, Sparks, Md, a segment of BD (Becton, Dickinson and Company), advises that the new BD MAX™ MRSA molecular test has received a Moderate Complexity rating under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Performed on the fully automated BD MAX System (pictured), the assay is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). A Moderate Complexity rating allows the assay to be performed by a qualified laboratory technician. Active detection and isolation of MRSA-colonized patients have been shown to help prevent transmission and reduce the rate of MRSA infections in hospitals. Rapid detection with molecular methods helps decrease unneeded pre-emptive isolation and shortens the time that patients are not properly isolated.
BD Diagnostics
(800) 638-8663
www.bd.com/ds/
Vitamin D Total Assay
Fast, accurate, easy-to-use test
VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay from Ortho Clinical Diagnostics, Raritan, NJ, is a new diagnostic test to measure levels of vitamin D2 and vitamin D3 in human serum and plasma for use on specific automated VITROS platforms. The assay is a fully automated, one-step immunoassay approved for use on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System. It provides customers with a fast, accurate, and easy-to-use test that meets the growing global demand for vitamin D testing. This assay quantitatively measures total 25(OH) vitamin D. The results are used in the assessment of vitamin D sufficiency and may be used in conjunction with other clinical or lab data to assist the clinician in patient management. It has a time to first result of 24 minutes. The company has filed a 510(k) Premarket Notification, which is pending clearance by the FDA.
Ortho Clinical Diagnostics
(800) 828-6316
www.orthoclinical.com
Gene Expression Test Kits
Achieves ISO certification
HTG Molecular Diagnostics, Tucson, Ariz, has achieved ISO 13485:2003 certification for the design, manufacture, and distribution of instruments, software, reagents, and test kits used in the analysis of gene expression. The certification covers its qNPA technology-based products and services in HTG Molecular Diagnostics’ portfolio.
HTG Molecular Diagnostics
(877) 289-2615
www.htgmolecular.com
Risk Stratification Test Gains Approval
Helps physicians assess aggregate breast cancer risk
BREVAGen™, a risk stratification test from Genetic Technologies Ltd, Australia, may now be offered in California after the Field Services Unit of the California Department of Public Health (CDPH) granted it a license. The test is designed to help physicians assess aggregate breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patient’s family and personal history, thus giving a clearer picture of an individual woman’s risk of developing breast cancer. The BREVAGen test may be especially useful for women predisposed to hormone-dependent breast cancer, including those who have undergone breast biopsies, as the test will provide information that can help physicians recommend alternative courses of action, such as more vigilant, targeted surveillance or preventive therapy.
Genetic Technologies Ltd
+61 3 8412 7000
www.gtglabs.com
