BD Diagnostics announced that it has received an approval letter from the US Food and Drug Administration (FDA) for the 510 (k) application to approve its automatic molecular detection technology for the detection and identification of HSV-1 and HSV-2.
BD Diagnostics is one of the three major business units of BD. The BD ProbeTec Qx HSV DNA amplification test provided by BD is the first automatic molecular detection technology, mainly used for HSV-1 and HSV in external genital samples (under clinical environment) -2 detection and identification. The technology runs on the BD Viper platform (using XTR technology), and uses strand displacement amplification technology for quantitative DNA detection and identification of HSV1 and HSV2.
The FDA does not approve this technique for the detection of cerebrospinal fluid and other physical injuries other than external genital injuries. The company said it cannot be used for prenatal screening and individuals under the age of 17.
BD ProbeTec Qx HSV DNA amplification detection technology can provide excellent "sensitivity and specificity" BD said, using this technology, the laboratory can read 96 negative or positive results in about two and a half hours, while traditional methods require 2 -10 days.
The company said that the laboratory using the Viper system with XTR technology can also analyze BD ProbeTec HSV1 and HSV2 Qx in automatic operation and test other samples of chlamydia and gonorrhea.
In a statement, Wayne Brinster, vice president and general manager of BD ’s Women ’s Health and Cancer Diagnostics Department, said that identifying patients with herpes simplex virus (HSV) and identifying the differences between type 1 and type 2 is the key to proper treatment.
"Our new herpes simplex virus (HSV) test is part of a molecular diagnostic product portfolio and is designed to provide clinicians with a better way to treat patients who have suffered from a variety of extremely serious sexually transmitted infections," he said.
The company submitted an approval application to the FDA in January.
In May 2010, EraGen Biosciences stated that its herpes simplex virus (HSV) test has been approved by the FDA and became the first molecular biological test to receive such a license.
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