Cowingene HPV (2+12) Detection Kit (Liquid)

検証検体:子宮頸管スワブ、尿、膣自己採取検体:1本;16、18、(31、33、35、39、45、51、52、56、58、59、66、68)



Cowingene HPV (2+12) Detection Kit (Liquid)


 
Intented Use

The HPV 2+12 Test is an in vitro diagnostic test for the qualitative detection of DNA from Human Papillomavirus (HPV) in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 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

参照 Product Name Type Package Size
HP02021X Cowingene HPV (2+12) Detection Kit 液体 48 tests/kit

 

Specification

Detection Target
16, 18, (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
Certification
CE- IVD
Storage
≤-20℃ for 18 months
LoD
100 Copies/mL
Validated Specimen
urine, cervical swab
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 type 16, 18 or other 12 high-risk HPV tested do not affect the test results of other channels.

Analytical Sensitivity

The detection limit of the 14 HPV types within the detection range of the kit (i.e., HPV 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 16, 18 and other 12 types.

 

Recommended Supporting  Reagents

参照 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 ウイルス DNA/RNA カラム CE 50tests/kit
CW02021Z Cowingene サンプル放出試薬 CE 100mL(10*10mL)
CW05021X Cowingene DNA/RNA Extraction kit CE 48テスト/キット

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