Cowingene HPV 16/18Detection Kit ( NATBox)

REF: HP09023W validated specimen: Cervical swab, Urine Analytes:Cartridge;16, 18.

Cowingene HPV16/18 Detection Kit (NATBox)


 
Intented Use

The HPV 16/18 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 HPV 16 and 18 in a single analysis. The test specifically identifies types HPV 16 and 18.

The HPV16/18 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

REFProduct NameTypePackage Size
HP09023WCowingene HPV16/18 Detection KitNATBox24 tests/kit

 

Specification

Detection Target
16, 18
Certification
CE- IVD
Storage
2-8℃ for 12 months
LoD
100 Copies/mL
Validated Specimen
urine, cervical swab
Compatible Instruments
NATBox® Mini II

 

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.

Precision

The %CV of inter/intra day, inter/intra batch and different operators/ sites are all ≤10.0% of HPV 16, 18.

 

Recommended Supporting  Reagents

REFProduct NameCertificationPackage Size
CW03021QCowingene Sample Collection Kit(Cervical/Urethral/Vaginal Swabs Collection)CE1 test/kit, 20 tests/box
CW04021QCowingene Sample Collection Kit(Urine Sample Collection)CE1 test/kit, 10 tests/box
CW09021WCowingene Sample Diluent Reagent (sample pre-treatment)CE1mL/vial, 24 vials/kit
CW07023QCowingene NATBox systemCE1 unit

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