Cowingene HPV (2+12) Detection Kit （NATBox®）
Cowingene HPV (2+12) Detection Kit (NATBox®)
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).
The HPV (2+12) Detection Kit is performed on the NATBox System. It is an automated in vitro diagnostic test system.
The NATBox Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in samples. The systems require the use of single-use cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized. For a full description of the system, please see the product manual of NATBox System.
Order Information
| REF | Product Name | Type | Package Size |
| HP02023W | Cowingene HPV (2+12) Detection Kit | Cartridge | 24 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 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
| 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 |
