Encephalitis/meningitis multi -disease primary nucleic acid combined detection kit (closed nest multi -PCR melting curve method) was approved for listing

Recently, the State Drug Administration was reviewed and approved the "Biofire Diagnostics (LLC)" encephalitis/meningitis multi -disease primary nucleic acid combined test kit (LLC) produced (LLC). ) "Application for registration of innovative products.

This product consists of the FilMarray ME test bar, sample buffer, dissolved solution, a red sample injection tube and an independent packaging pipette pipe. The cerebrospinal fluid (CSF) samples of the encephalitis signs and/or symptoms of the crowds of the crowd (CSF) samples of 14 bacteria, viruses, and invisible bacteria of the encephalide sample.

This product adopts a closed nest multi -PCR fusion curve method. Based on multiple nest PCR amplification and felting curve analysis technology, the samples after mechanical grinding are detected and analyzed. Multi -nest PCR amplification combination combined with melting curve analysis technology improves the response sensitivity and specificity of the testing kit, and the system software automatically evaluates data and reports the results.

This product detection and identification of 14 potential central nervous system infection related pathogens in CSF can obtain test results in about 1 hour. Cereals such as meningitis bring a burden on patients.

The drug supervision and management department will strengthen the supervision of the product after listing to protect the safety of patients.

Attachment: Innovative medical equipment approved by the State Drug Administration

Source: State Drug Administration

- END -