The HPV 5+9 Test is an in vitro diagnostic real-time PCR (real-time PCR) assay for the qualitative detection and genotyping of high-risk human papillomavirus (HPV) DNA in cervical specimens. It identifies the five most clinically important high-risk types — HPV16, HPV18, HPV52, HPV33, and HPV58 — while simultaneously detecting the remaining nine high-risk types (31, 35, 39, 45, 51, 56, 59, 66, and 68), covering all 14 high-risk HPV types in a single analysis.
WHY TEST FOR HIGH-RISK HPV?
Persistent infection with high-risk human papillomavirus is the principal cause of cervical cancer and its precursor lesions (cervical intraepithelial neoplasia, CIN), with HPV implicated in more than 99% of cervical cancers worldwide. HPV is a small, non-enveloped, double-stranded DNA virus with more than 118 known types, of which approximately 14 are classified as high-risk. While HPV infection is extremely common — up to 75% of women are exposed at some point — and most infections clear spontaneously within two years, persistent high-risk infection can progress to cervical cancer. Molecular HPV DNA testing offers key advantages over traditional Pap smear cytology:
• Higher sensitivity for high-grade lesions, detecting cervical disease earlier in women 30 and older with NILM cytology
• Objective, reproducible results that reduce reliance on subjective cytopathology interpretation
• Better triage of ASC-US cytology in women 21 and older, reducing unnecessary colposcopy and treatment
• Identifies specific high-risk genotypes to support risk stratification and vaccination follow-up
KEY FEATURES
• Detects and differentiates all 14 high-risk HPV types in a single test
• Specifically identifies HPV16, HPV18, HPV52, HPV33, and HPV58 (the "5")
• Concurrently detects the remaining 9 high-risk types: 31, 35, 39, 45, 51, 56, 59, 66, and 68
• Multiplex real-time PCR with four-channel fluorescent detection (FAM, VIC/HEX, ROX, CY5)
• Integrated β-globin internal control monitors extraction, amplification, and detection in every sample
• High sensitivity: limit of detection ≤100 copies/test
• Excellent precision: coefficient of variation (CV) ≤5%
• CE marked, for professional in vitro diagnostic use
CLINICAL VALIDATION
Comparative clinical studies across three provincial hospitals totaling 1,000 samples, using DNA sequencing as the reference method, demonstrated a Kappa value of 1 with 100% positive coincidence rate, 100% negative coincidence rate, and 100% total coincidence rate. An additional 200-sample study against a 27-type HPV genotyping assay showed the same 100% concordance.
SPECIFICATIONS
• Specimen type: cervical exfoliated cells collected in cell preservation solution
• Methodology: multiplex real-time fluorescent PCR (four-channel detection)
• Packaging: 48 tests/kit
• Compatible instruments: open real-time PCR systems with FAM, VIC/HEX, ROX, and CY5 channels (e.g., ABI 7500, Roche LightCycler® 480)
• Storage: ≤ -20°C, protected from light; shelf life 6 months
• Detection coverage: 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
TARGET USERS
Clinical laboratories, hospital gynecology and pathology departments, and molecular diagnostic centers performing cervical cancer screening and HPV genotyping for women's health programs.
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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