Cowingene HPV Genotyping Detection Kit-HPV-16 Panel (Liquid)

REF: HP12021X Validated Specimen: Cervical swab, Urine, Self-collected vaginal swabs Analytes：HPV6，HPV11，HPV16，HPV18 types and other 12 high- risk HPV types （ 31,33,35,39,45,51,52,56,58,59,66,68）in a single channel

CONTACT NOW

Cowingene HPV Genotyping Detection Kit-HPV-16 Panel (Liquid)

Intented Use

The Cowingene HPV Genotyping Detection Kit (HPV Detection Kit) is an in vitro diagnostic test for the qualitative detection of DNA from Human Papillomavirus (HPV) in patient specimens.
This kit specifically identifies high risk types HPV 16, HPV 18 and low risk types HPV 6, HPV 11 while concurrently detection the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

Order Information

REF	Product Name	Type	Package Size
HP12021X	Cowingene HPV Genotyping Detection Kit	Liquid	48 tests/kit

Specification

Detection Target

HPV6，HPV11，HPV16，HPV18 types and other 12 high- risk HPV types （ 31,33,35,39,45,51,52,56,58,59,66,68）in a single channel

Storage

≤-20℃ for 18 months

LoD

The detection limit of the HPV types within the detection range of the kit (i.e., HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) is 100 Copies/mL.

Validated Specimen

Cervical swab, Urine, Self-collected vaginal swabs

Compatible Instruments

Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, i.e. ABI 7500, Roche 480, Bio-Rad CFX96, etc.

Performance Characteristics

Cross-reactivity	All results are negative when the kit is used to detect non-specific specimens that may have cross reactions with it, including ureaplasma urealyticum, chlamydia trachomatis of reproductive tract, candida albicans, neisseria gonorrhoeae, trichomonas vaginalis, mold, gardnerella and other HPV types not covered by the kit.
Interfering Substances	The following substances: hemoglobin (200mg/L), white blood cells (10^9), Metronidazole (2mg/mL), cervical mucus, jieeryin lotion, fuyanjie lotion, human lubricant do not affect the test results of the kit.
Analytical Sensitivity	The detection limit of the HPV types within the detection range of the kit (i.e., HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) is 100 Copies/mL.
Precision	The %CV of inter/intra day, inter/intra batch and different operators/ sites are all ≤5.0% of HPV 6, HPV11, HPV 16, 18 and other 12 types.

Recommended Supporting Reagents

REF	Product Name	Certification	Package Size
CW03021Q	Cowingene Sample Collection Kit（Self-collected vaginal）	CE	1 test/kit
CW04021Q	Cowingene Sample Collection Kit（Self-collected urine）	CE	1 test/kit
CW01021Y	Cowingene Viral DNA/RNA Column	CE	50 tests/kit
CW02021Z	Cowingene Sample Release Reagent	CE	100 mL(10*10mL)
CW05021X	Cowingene DNA/RNA Extraction kit	CE	48 tests/kit