CACLP - The largest IVD Expo & Conference

Streck Quality Controls for DiaSorin's Luminex Sepsis Tests Receive FDA Clearance

Industry news | 26 September, 2023 | CACLP

Original from: genomeweb

 

Streck announced on Monday that its MDx-Chex quality controls have received clearance from the US Food and Drug Administration. 

 

The quality controls are designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive and Gram-Negative tests for bloodstream infection and sepsis, Streck said in a statement. They evaluate the entire analytical process of the DiaSorin subsidiary's tests, including cell lysis, DNA extraction, and DNA hybridization, detection, and analysis. Each control contains intact, inactivated microorganisms suspended in a matrix of stabilized red blood cells, white blood cells, and blood culture media components, Streck said.

 

The MDx-Chex controls can be used for assay verification, to track lot-to-lot performance of tests, and to reduce the occurrence of incorrect results because of instrument or test failures, Streck noted. 

 

The FDA clearance "further substantiates the quality and performance of MDx-Chex products, now with the addition of quality controls for BC-GP and BC-GN panels on the Luminex Verigene system," Chris Connelly, director of R&D for Streck, said in a statement. "It is crucial for labs to have access to controls that verify all sample processing steps needed for nucleic acid-based tests and instrumentation."

 

Source: Streck Quality Controls for DiaSorin's Luminex Sepsis Tests Receive FDA Clearance

 

Press contact CACLP - The largest IVD Expo & Conference

Stay in touch with CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News, sign-up for our newsletter today.

  • Name *
  • Email *
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By subscribing our newsletter, you agree to our Privacy Policy. You can unsubscribe at anytime.

Share
Opening Countdown
0 0 0

Day(s)

0 0

Hour(s)

0 0

Min(s)

Room 2201-2203 & 2205, Cloud Nine Plaza
1118 West Yan’an Road
Shanghai, China
200052

Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )

We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy & Cookies for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

CACLP - The largest IVD Expo & Conference