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

REF: HP13021V, HP13021Y 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, 53, 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)

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

REFProduct NameTypePackage Size
HP13021VCowingene HPV Genotyping Detection (HPV-40 panel)Liquid20 tests/kit
HP13021YCowingene HPV Genotyping Detection (HPV-40 panel)Liquid50tests/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)
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/Vaginal/Urethral Swab, Urine, LBC

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

REFProduct NameCertificationPackage Size
CW03021QCowingene Sample Collection Kit(Cervical/Urethral/Vaginal Swabs CollectionCE1 test/kit, 20 tests/box
CW04021QCowingene Sample Collection Kit(Urine Sample Collection)CE1 test/kit, 10 tests/box
CW01021YCowingene Viral DNA/RNA ColumnCE50 tests/kit
CW02021ZCowingene Sample Release ReagentCE100 mL(10*10mL)
CW05021XCowingene DNA/RNA Extraction kitCE48 tests/kit

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