Cowingene HPV 15 Genotyping Detection Kit(Liquid)
Cowingene HPV 15 Genotyping Detection Kit (Liquid)
The HPV 15 Genotyping Detection 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 15 high-risk HPV types in 4 analysis. The test identifies the high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68).
Order Information
| REF | Product Name | Type | Package Size |
| HP03021V | Cowingene HPV 15 Genotyping Detection Kit | Liquid | 20 tests/kit |
| HP03021Y | Liquid | 50 tests/kit |
Specification
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 others. |
| Analytical Sensitivity | The detection limit of the 15 HPV types within the detection range of the kit (i.e., HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 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 each HPV type. |
Recommended Supporting Reagents
| Product Name | REF | Package | Details | Regulatory Achieved |
| Cowingene Sample Collection Kit | CW03021Q | 1 test/kit, 20 tests/box | Cervical/Urethral/Vaginal Swabs Collection | CE-IVDR |
| CW04021Q | 1 test/kit, 10 tests/box | Urine Sample Collection | CE-IVDR | |
| Cowingene Viral DNA/RNA Column | CW01021Y | 50 tests/kit | DNA/RNA Extraction, Column Spin | CE-IVDR |
| Cowingene DNA/RNA Extraction kit | CW05021N | 40 tests/kit | DNA/RNA Extraction, Maual | CE-IVDR |
| CW05021M | 64 tests/kit | DNA/RNA Extraction,Single-Test Format, Automatic | CE-IVDR | |
| CW05021X | 48 tests/kit | DNA/RNA Extraction,Multi-Test Format, Automatic | CE-IVDR | |
| NATPure System | CW11022Q-16 | CWNP-16 | DNA/RNA Extraction Machine | CE-IVDR |
| CW11022Q-32 | CWNP-32 | DNA/RNA Extraction Machine | CE-IVDR |
