QIAstat-Dx ME Panel - India CDSCO Medical Device Registration

Product Information

The QIAstat-Dx Meningitis/Encephalitis (QIAstat-Dx) Panel (QIAstat-Dx) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the QIAstat-Dx System. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (QIAstat-Dx) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified and differentiated using the QIAstat-Dx ME Panel: Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (QIAstat-Dx), Streptococcus agalactiae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Streptococcus pyogenes, Herpes simplex virus 1, Herpes simplex virus 2, Human herpes virus 6, Enterovirus, Human parechovirus, Varicella-zoster virus and Cryptococcus neoformans/gattii*. The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results must be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the QIAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agent or agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (QIAstat-Dx) infection. Not all agents of CNS infection are detected by this test, and sensitivity in clinical use may differ from that described in the package insert.