Diagnostics Product Guide » Point of Care Testing

Study Suggests EEG Test Can Identify People who can Develop Mental Disorder

admin — Fri, 09 Jul 2010 19:05:10 +0000

Information from an EEG (electroencephalography) test could allow doctors to identify people at high risk of a particular mental disorder, such as schizophrenia. Scientists have found that a type of EEG brain wave is slightly different in people who have siblings with schizophrenia, compared with that seen in the general population. The researchers believe the information could be used to identify those at highest risk and pre-emptively treat them before they develop a full-blown mental disorder.

Epocal Announces FDA Clearance Of Lactate Test

admin — Wed, 23 Jun 2010 11:10:58 +0000

Epocal, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) clearance to market its new lactate test on the epoc Blood Analysis System. Lactate measurements from the epoc System are used to evaluate acid-base status and for diagnosis and treatment of lactic acidosis. The addition of lactate to the epoc BGEM Test Card further expands the clinical utility of the Company’s point of care blood gas and electrolyte platform.

Read the full story here

First HIV diagnostic assay approved

admin — Tue, 20 Oct 2009 07:26:29 +0000

Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

Urine tests may help in personalized drug prescriptions

admin — Tue, 11 Aug 2009 10:47:11 +0000

Under a new approach pioneered by British scientists from Imperial College London and Pfizer, patients who need drug treatment could be given individually tailored prescriptions based on the results of simple urine tests. New research has shown that chemical signatures predicting how a patient will respond to particular drugs can be detected in urine, paving the way for the development of tests to help doctors prescribe more safely and effectively.

FDA’s expanded indication for Chembio’s POC testing

admin — Mon, 13 Oct 2008 06:06:14 +0000

The U.S. Food and Drug Administration has given approval to Chembio Diagnostics, Inc. to extend the age range for its HIV rapid point-of-care testing by lowering the age limit to 13 years and above from 18 years. The Laboratory of Viral Diagnostics, University of Maryland School of Medicine, conducted a clinical study and recommended the expansion of age limit on the basis of the study’s findings. The test can be carried out in primary care settings.

Yale doctors create a POC testing system

admin — Fri, 10 Oct 2008 14:59:48 +0000

Scientists at Yale Institute for Nanoscience and Quantum Electronics have developed nanowire sensors attached with simple microprocessor electronics which are both sensitive and specific enough to be used for point-of-care (POC) disease detection. When highly specific antigens activate immune cells, acid is produced. A current is generated in the nanowire electronics. This indicates that a specific antigen (viruses, bacteria or cancer cell) is present, allowing for detection. The system gives results really fast and is compatible with the currently available CMOS electronics.

U.K. researchers develop faster blood test for tuberculosis

admin — Thu, 13 Mar 2008 22:07:53 +0000

A team of U.K. researchers at Imperial College London has developed a blood test that enables doctors to rule out tuberculosis (TB) infection in patients within a few days, rather than weeks. TB is difficult to diagnose because its symptoms include fever, fatigue and loss of appetite, which are associated with other conditions as well. The new blood test would prevent patients who do not have TB from being subjected to lengthy TB tests and patients with TB to undergo treatment earlier.

FDA OKs Vision-Sciences cystoscopy line

admin — Tue, 11 Mar 2008 14:19:16 +0000

Vision-Sciences Inc. has received FDA approval for its 510(k) submission to market its advanced digital, video-based cystoscope line. The cystoscope line is meant to be used along with an integrated built-in light source, eliminating the need for a separate camera head, light guide cable and optical coupler. These lightweight videoscopes facilitate diagnostic and therapeutic procedures with the introduction of the world’s smallest diameter videoscope insertion tube containing a high resolution, miniature CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition, vibrant, full screen image.

Quidel receives CLIA waiver for QuickVue RSV test

admin — Mon, 03 Mar 2008 19:33:13 +0000

Quidel Corporation has announced that the FDA has granted a CLIA (clinical laboratory improvement amendments) waiver for the QuickVue test. This test enables the qualitative detection of the respiratory syncytial virus (RSV). The American Academy of Pediatrics has recognized RSV as the primary cause of pneumonia and bronchiolitis in children of 2 years of age and below. The waiver allows the QuickVue RSV test to be made more widely available for use, especially in clinics and offices of physicians, where waived tests are used most frequently.