The National Medical Products Administration (NMPA) website indicates that BioFire Diagnostics LLC’s encephalitis/meningitis multiple pathogen nucleic acid combined detection kit has been approved for marketing as an innovative product. The kit uses a closed nested multiplex PCR melting curve method for the qualitative detection of meningitis and/or nucleic acids of 14 bacterial, viral, and stealth cocci in cerebrospinal fluid (CSF) samples from patients showing signs and/or symptoms of encephalitis.
Product Details
The product, which includes FilmArray ME test strips, sample buffer, lysate, single-use red sample syringes, and individually packaged pipettes, is a single-use closed detection reagent. It adopts a closed nested multiplex PCR melting curve method, based on multiple nested PCR amplification and melting curve analysis technology. This method improves the reaction sensitivity and specificity of the detection kit. The system software automatically evaluates the data and reports the results.
Diagnostic Advantages
When used to detect and identify 14 potential central nervous system infection – related pathogens in CSF, the kit can obtain detection results in about 1 hour. This significantly speeds up the etiological diagnosis of encephalitis and meningitis, allowing for targeted clinical treatment to be carried out as soon as possible.-Fineline Info & Tech
