Cowingene Meningitis Panel 18 Detection Kit

validated specimen: CSF Analytes：5tube; Escherichia coli K1 (E. coli K1) , Group B Streptococcus (GBS), Haemophilus influenzae (HI), Listeria monocytogenes (LM), Neisseria meningitidis (NM), Streptococcus pneumoniae (SP), Adenovirus (AdV), Enterovirus (HEV), Human parechovirus (HPeV), Mumps virus (MV), Parvovirus B19 (B19V), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Herpes simplex virus type 1 (HSV1), Herpes simplex virus type 2 (HSV2), Human herpes virus 6 (HHV 6), Human herpes virus 7 (HHV 7), Varicella-zoster virus (VZV)

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ORDER INFORMATION	REF TYPE PACKAGE
	NI04021W Liquid 20tests/kit
	NI04022U Lyophilized 16tests/kit
INDICATION	in vitro diagnostic medical device
REGULATORY STATUS	CE-IVD
INTENDED USER	For professional use in laboratories with trained staff
TECHNOLOGY	Real-time PCR
TYPE OF ANALYSIS	Qualitative
ANALYTICAL SPECIFICITY	Escherichia coli K1,Group B Streptococcus,Haemophilus influenzae,Listeria monocytogenes,Neisseria meningitidis,Streptococcus pneumoniae), Adenovirus, Enterovirus, Human parechovirus, Mumps virus, Parvovirus B19, Cytomegalovirus, Epstein-Barr virus, Herpes simplex virus type 1), Herpes simplex virus type 2, Human herpes virus 6, Human herpes virus 7, Varicella-zoster virus
ANALYTICAL SENSITIVITY (LoD with probability 95 %)	reaches up to 1000 cp/ml with the probability of 95 % (on DNA control)
EXTRACTION/INHIBITION CONTROL	PCR inhibition and RNA extraction efficiency control by Internal Control (IC)
REPORTING UNITS	cp/ml
VALIDATED SPECIMEN	Cerebrospinal fluid
TYPE	Liquid Lyophilized
STORAGE	≤-20℃ 2-30℃
SHELF LIFE	18months 18months
REACTION TIME	90mins 80mins
DIAGNOSTIC SPECIFICITY	100.00 % (CI95%:97.32 % – 100.00 %) 100.00 % (CI95%:97.13 % – 100.00 %)
DIAGNOSTIC SENSITIVITY	100.00 % (CI95%: 96.67 % – 100.00 %) 100.00 % (CI95%: 96.83 % – 100.00 %)
VALIDATED EXTRACTION METHOD	Cowingene Viral DNA/RNA Column
	Cowingene Sample release reagent
APPLIED INSTRUMENTS	CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System	QuantStudio™ 3 / 5 Real-Time PCR System
	Applied Biosystems 7300 / 7500 Real-Time PCR System	Rotor-Gene™ 3000 / 6000 / Q
	SLAN® Real-Time PCR System	MA-9600P/MA-6000 Real-Time Quantitative Thermal Cycler
	LightCycler® 480	LineGene 9600 Plus
	croBEE™ Real-Time PCR System	Gentier 96E/96R Real-Time PCR System
	AriaMx Real-Time PCR System	Mic qPCR Cycler
	BioQuant-96 Real-Time PCR System	AMPLilab Real-Time PCR System
REQUIRED DETECTION CHANNELS	FAM, HEX，ROX，CY5