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

REF: HP13022S, HP13022X Validated Specimen: Urine, Cervical Swab, Vaginal Swab, Urethral Swab, Residual LBC Specimen 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 (lyophilized)


 
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
HP13022SCowingene HPV Genotyping Detection (HPV-40 Panel)Lyophilized
8 tests/kit
HP13022XCowingene HPV Genotyping Detection (HPV-40 Panel)Lyophilized48 tests/kit

 

Specification

Detection Target
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) in a single channel
Certification
CE- IVD
Storage
2-30℃ 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
Urine, Cervical Swab, Vaginal Swab, Urethral Swab, Residual LBC Specimen
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

Product NameREFPackageDetailsRegulatory Achieved
Cowingene Sample Collection Kit
CW03021Q1 test/kit, 20 tests/boxCervical/Urethral/Vaginal Swabs CollectionCE-IVDR
CW04021Q1 test/kit, 10 tests/boxUrine Sample CollectionCE-IVDR
Cowingene Viral DNA/RNA ColumnCW01021Y50 tests/kitDNA/RNA Extraction, Column SpinCE-IVDR
Cowingene DNA/RNA Extraction kit
CW05021N40 tests/kitDNA/RNA Extraction, MaualCE-IVDR
CW05021M64 tests/kitDNA/RNA Extraction,Single-Test Format, AutomaticCE-IVDR
CW05021X48 tests/kitDNA/RNA Extraction,Multi-Test Format, AutomaticCE-IVDR
NATPure System
CW11022Q-16CWNP-16DNA/RNA Extraction MachineCE-IVDR
CW11022Q-32CWNP-32DNA/RNA Extraction MachineCE-IVDR


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