14 High-Risk HPV Detection Kit with 16/18 Genotyping (Fluorescence PCR)

Qualitative PCR detection of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in cervical exfoliated cells, with simultaneous genotyping of HPV 16 and 18. Aids in diagnosis and management of HPV infection.

SKU Code
AENE-CC010
Approval
On request
Product Type
Assay / Kit
Status
Available

Qualitative PCR detection of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in cervical exfoliated cells, with simultaneous genotyping of HPV 16 and 18. Aids in diagnosis and management of HPV infection.

Product typeAssay / Kit
Technology platformFluorescence PCR
Application areaHPV

Certificate

CE

Epidemiology

This assay enables in vitro qualitative identification of nucleic acid fragments specific to 14 human papillomavirus genotypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in urine, cervical swabs, and vaginal swabs from females, along with separate typing for HPV 16 and 18, supporting the diagnosis and management of HPV infections.
Human papillomavirus (HPV) is a member of the Papillomaviridae family, characterized as a small, non-enveloped virus with a circular double-stranded DNA genome of approximately 8,000 base pairs. Transmission to humans occurs via direct or indirect contact with contaminated objects or through sexual activity. HPV exhibits both host and tissue specificity, infecting exclusively human skin and mucosal epithelial cells. This leads to diverse skin papillomas or warts, as well as proliferative lesions in the reproductive tract epithelium.

SKU codeAENE-CC010
StorageLiquid: ≤-18℃; Lyophilized: ≤30℃ In dark
Shelf-life12 months
Specimen TypeLiquid:Cervical Swab, Vaginal Swab, Urine Freeze-dried:cervical exfoliated cells
Ct≤28
CV≤5.0 %
LoD300 Copies/mL
SpecificityNo cross-reactivity with common reproductive tract pathogens (such as ureaplasma urealyticum, genital tract chlamydia trachomatis, candida albicans, neisseria gonorrhoeae, trichomonas vaginalis, mold, gardnerella and other HPV types not covered in the kit, etc).
Applicable InstrumentsIt can match the mainstream fluorescent PCR instruments on the market. Applied Biosystems 7500 Real-Time PCR System Applied Biosystems 7500 Fast Real-Time PCR Systems QuantStudio ® 5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems LightCycler ® 480 Real-Time PCR Systems LineGene 9600 Plus Real-Time PCR Detection Systems MA-6000 Real-Time Quantitative Thermal Cycler BioRad CFX96 Real-Time PCR System BioRad CFX Opus 96 Real-Time PCR System
ApprovalOn request
DocumentsDatasheet, IFU, SDS, COA / conformance, origin, and export documents where available

FAQ

What should be confirmed before quotation?

Sample context, collection method, and extraction workflow should be confirmed before final kit selection.

Which documents can be requested?

Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.

Can the format be adjusted for different workflows?

Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.

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