Cowingene HPV Genotyping Detection Kit-HPV-40 Panel (Liquid)

REF: HP13021V Validated Specimen: Cervical swab, Urine, Self-collected vaginal Analytes：5 tube;15 high- risk HPV types: 16,18,31,33,35,39,45,51,52,56,58,59,66,68; 2 low- risk HPV types: 6,11; and other 23 low- risk HPV types(26, 30, 32, 34, 40, 42, 43, 44, 54, 55, 61, 62, 67, 69, 70, 73, 74, 81, 82, 83, 84, 87, and 90) in a single channel

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Cowingene HPV Genotyping Detection Kit-HPV-40 Panel (Liquid)

Intented Use

The HPV Genotyping Detection Test is an in vitro diagnostic test for the qualitative detection of DNA from Human Papillomavirus (HPV) in patient specimens. The test specifically identifies 15 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) and 2 low-risk types (6, 11), each detected through individual channels. Additionally, it concurrently detects the other 23 low-risk HPV types (26, 30, 32, 34, 40, 42, 43, 44, 54, 55, 61, 62, 67, 69, 70, 73, 74, 81, 82, 83, 84, 87, and 90) in a single channel without further differentiation.

Order Information

REF	Product Name	Type	Package Size
HP13021V	Cowingene HPV Genotyping Detection	Liquid	20 tests/kit

Specification

Detection Target

15 high- risk HPV types: 16,18,31,33,35,39,45,51,52,56,58,59,66,68; 2 low- risk HPV types: 6,11; and other 23 low- risk HPV types(26, 30, 32, 34, 40, 42, 43, 44, 54, 55, 61, 62, 67, 69, 70, 73, 74, 81, 82, 83, 84, 87, and 90) in a single channel

Certification

CE- IVD

Storage

≤-20℃ for 18 months

LoD

The detection limit of the 40 HPV types within the detection range of the kit is 100 Copies/mL.

Validated Specimen

Cervical swab, Urine, Self-collected vaginal

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.
Competitive Interference	The HPV types tested in the same HPV Mix do not affect the test results of other.
Analytical Sensitivity	The detection limit of the 40 HPV types within the detection range of the kit is 100 Copies/mL.
Precision	The %CV of inter/intra day, inter/intra batch and different operators/ sites are all ≤5.0% of each HPV type.

Recommended Supporting Reagents

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