The HPV 27 Genotyping Assay is an in vitro diagnostic test for the qualitative detection and individual genotyping of 27 human papillomavirus (HPV) types in cervical specimens. Using flow fluorescence hybridization technology on a Luminex platform, the assay identifies 17 high-risk HPV (hrHPV) types and 10 low-risk HPV (lrHPV) types in a single run, together with a built-in beta-globin internal control — providing comprehensive whole-genome HPV genotyping for cervical cancer risk assessment and clinical management.
WHY HPV 27 GENOTYPING?
Cervical cancer is the only cancer with a clearly defined etiology: it cannot occur without persistent infection by the same high-risk HPV type. Identifying the specific HPV genotype and tracking its persistence is therefore essential for risk stratification, vaccination follow-up, and individual clinical management. Compared with pooled or partial HPV screening, full 27-type genotyping delivers:
• Complete coverage of 17 high-risk types — including all 14 WHO-recognized hrHPV types plus 3 additional (HPV 26, 53, 82) — and the 10 most clinically relevant low-risk types
• Individual identification of every genotype rather than pooled detection, enabling risk-graded follow-up and genotype-specific tracking over time
• Objective, reproducible molecular results that surpass Pap cytology in sensitivity and negative predictive value
• Whole-genome level data ready for downstream cancer risk grading and management
KEY FEATURES
• Detects and individually genotypes 27 HPV types + 1 internal control in a single assay (27+1)
• 17 high-risk types: HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 82
• 10 low-risk types: HPV 6, 11, 40, 42, 43, 44, 55, 61, 81, 83
• Flow fluorescence hybridization on the Luminex 100/200 platform — the only high-throughput diagnostic technology included in the U.S. clinical laboratory quality control network
• Integrated beta-globin internal control monitors sample adequacy, extraction efficiency, and PCR integrity
• Automated software analysis and interpretation for digital, standardized reporting
• Fast total turnaround: approximately 4 hours with less than 30 minutes of manual operation
• CE marked, WHO HPV LabNet proficiency-tested, and registered under China NMPA
CLINICAL VALIDATION & COMPLIANCE
Built on the Flow Fluorescence — WHO HPV Reference Laboratory Quality Control Product Assessment Technology Platform (per the WHO HPV LabNet 2014 International Proficiency Panel for HPV DNA Detection and Typing). The assay holds international approvals including CE, WHO HPV LabNet proficiency study, and China NMPA (formerly CFDA) registration.
SPECIFICATIONS
• Specimen type: cervical exfoliated cells collected in cell preservation solution
• Methodology: multiplex PCR + flow fluorescence hybridization
• Packaging: 48 tests/kit
• Compatible instrument: Luminex 100/200
• Total operation time: approximately 4 hours; manual hands-on time less than 30 minutes
• Result analysis: automated by dedicated software
• Storage: as indicated on the product label, protected from light
TARGET USERS
Clinical laboratories, hospital gynecology and pathology departments, and molecular diagnostic centers performing large-scale cervical cancer screening programs, HPV genotype-specific risk management, and post-vaccination surveillance.
Note: For in vitro diagnostic use only. Results are for clinical reference and should be interpreted by a clinician together with cytology findings and other diagnostic information.
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