Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit

validated specimen: Cervical swab,Anorectal swab,Urine,Self-collected vaginal Analytes：4 tube；Chlamydia trachomatis (CT),Neisseria gonorrhoeae (NG),Herpes simplex virus type 1 (HSV1),Herpes simplex virus type 2 (HSV2),Ureaplasma urealyticum(UU),Ureaplasma parvum (UP),Mycoplasma hominis (MH),Mycoplasma genitalium (MG),Candida albicans (CA),Gardnerella vaginalis (GV),Trichomonas vaginalis (TV),Group B Streptococcus(GBS),Hemophilus ducreyi（HD）,Treponema pallidum(TP).

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ORDER INFORMATION	REF TYPE PACKAGE
	ST01021V Liquid 20tests/kit
	ST01022U 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	Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma hominis, Herpes simplex virus type 1, Ureaplasma urealyticum, Herpessimplex virus type 2, Ureaplasma parvum, Mycoplasma genitalium, Candida albicans, Gardnerella vaginalis, Trichomonal vaginitis, Group B streptococci, Haemophilus ducreyi, and Treponema pallidum
ANALYTICAL SENSITIVITY (LoD with probability 95 %)	reaches up to 100 cp/ml with the probability of 95 % (on HPV DNA control, GeneWell)
EXTRACTION/INHIBITION CONTROL	PCR inhibition and DNA extraction efficiency control by Internal Control (IC)
REPORTING UNITS	cp/ml
VALIDATED SPECIMEN	male urethral swab,female cervical swab,female vaginal swab,urine
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

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