Data Integrity White Paper

FDA Clearance for Solana® C. difficile Molecular Assay

Quidel Corporation has received 510(k) FDA clearance to market its Solana® C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens of patients suspected of having C. difficile-infection (CDI).

Traditional methods for diagnosing CDI, such as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack sensitivity and increase lab costs due to additional confirmation testing. In addition to significant technical expertise, cytotoxicity assays and toxigenic culture require 24 to 48 hours and 3 to 5 days, respectively, before reliable results can be obtained. The Solana C. difficile assay will now enable laboratories to offer a fast and sensitive result generated by molecular methods, without an upfront nucleic acid extraction step.

The Solana C. difficile Assay is an easy-to-use, accurate, molecular diagnostic test that generates an accurate result in about 35 minutes.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 different assays or patient samples in each batched run, and provides time-saving workflow advantages to healthcare professionals in moderately complex settings.

The Solana® C. difficile Assay is Quidel's first molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format for diagnosis of a Healthcare Associated Infection (HAI). Other 510(k) cleared Solana molecular diagnostic assays include:
 

Solana® HSV 1+2/VZV Assay STI Cleared 11/28/16
Solana® Complete (Strep A + C/G) Assay Respiratory Cleared 10/25/16
Solana® Influenza A+B Assay Respiratory Cleared 09/27/16
Solana® Trichomonas Assay STI Cleared 08/15/16
Solana® Group A Strep Assay Respiratory Cleared 06/23/15

 
With the Solana franchise, Quidel has broadened its molecular strategy to include instrumented systems, and grown the number of its molecular platforms that are both 510(k) cleared and available commercially. Quidel's other FDA cleared molecular solutions include the AmpliVue® non-instrumented system for lower-volume moderately complex labs, and Lyra® reagents for higher throughput, highly complex laboratories that are compatible with existing PCR infrastructure.


     
Tags: Clostridium difficile, Healthcare-associated Infections

Date Published: May 30, 2017

Source article link: Quidel Corporation » company contact details
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