Cowingene HPV 6/11 Detection Kit (Liquid)

REF: HP11021X validated specimen: Urine, Cervical Swab, Vaginal Swab, Urethral Swab, Residual LBC Specimen Analytes: 1 tube; 6,11

Cowingene HPV 6/11 Detection Kit (Liquid)


 
Intented Use

The HPV 6/11 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 types 6 and 11 in a single analysis. The test specifically identifies types HPV 6 and HPV 11.

 

Order Information

REFProduct NameTypePackage Size
HP11021XCowingene HPV 6/11 Detection KitLiquid48 tests/kit

 

Specification

Detection Target
6,11
Certification
CE- IVD
Storage
≤-20℃ for 18 months
LoD
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 type 6 and HPV type 11 tested do not affect the test results of each other.

Analytical Sensitivity

The detection limit of the HPV 6 and HPV 11 is 100 Copies/mL.

Precision

The %CV of inter/intra day, inter/intra batch and different operators/ sites are all ≤5.0% of HPV 6 and HPV 11.

 

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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