OVERVIEW
The HPV 2+12 High-Risk Human Papillomavirus Genotyping Kit is a real-time PCR assay for the qualitative detection and genotyping of high-risk human papillomavirus (HR HPV) DNA in cervical specimens collected in cell preservation solution. The test specifically identifies HPV 16 and HPV 18 on dedicated fluorescence channels while concurrently detecting the remaining twelve high-risk types — 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 — as a pooled group, all within a single reaction. A co-amplified beta-globin internal control monitors specimen adequacy, DNA extraction, and PCR inhibition across the entire testing process, distinguishing true HPV-negative results from false negatives caused by insufficient cellular material.
WHY TEST FOR HIGH-RISK HPV?
Persistent infection with high-risk human papillomavirus is the necessary cause of cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN). HPV DNA is implicated in greater than 99% of cervical cancers worldwide. Although exposure is extremely common — up to 75% of women encounter HPV at some point — the vast majority clear the infection within two years without consequence. Only persistent infection with one of the approximately 14 high-risk types carries meaningful risk of progression. HPV 16 and HPV 18 are the most carcinogenic genotypes and account for the majority of HPV-driven cervical cancers, which is why they are reported individually to support genotype-specific risk stratification and patient management.
WHY THIS KIT?
The HPV 2+12 kit is designed as an economical, single-tube solution for cervical cancer screening and ASC-US triage. It answers the two questions that matter most for clinical management: is any high-risk HPV present, and is the genotype the highly carcinogenic HPV 16 or 18? Individual reporting of HPV 16/18 enables immediate risk-stratified action — such as referral to colposcopy — while the pooled detection of the other twelve high-risk types provides comprehensive coverage without the added cost of full 14-type individual genotyping.
INDICATIONS FOR USE
- Triage of patients aged 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for colposcopy
- Assessment of HPV 16 and 18 status in patients aged 21 years and older with ASC-US cytology
- Adjunctive screening in combination with cervical cytology for women aged 30 years and older
- Assessment of HPV 16 and 18 status in women aged 30 years and older
KEY FEATURES
- Single-tube real-time PCR detecting all 14 high-risk HPV types in one reaction
- Individual genotyping of HPV 16 and HPV 18 on dedicated fluorescence channels, with the remaining 12 high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) detected as a pooled signal
- Four-channel detection (FAM / HEX-VIC / ROX / CY5) using fluorophore-labeled hydrolysis probes
- Beta-globin internal control co-amplified and detected on a dedicated channel to flag false negatives caused by insufficient cell mass, poor extraction, or PCR inhibition
- Positive and negative external controls included in every kit
- Limit of detection <= 100 copies/test for all 14 high-risk types
- Precision CV <= 5% across HPV 16, 18, and 45 reference materials at 100 and 500 copies/test
- No cross-reactivity with low-risk HPV types (cross-reaction rate <= 10%) or common genital-tract pathogens including Mycoplasma, Chlamydia trachomatis, Candida albicans, Neisseria gonorrhoeae, Trichomonas, and Gardnerella vaginalis
- No interference from vaginal wash lotions, vaginal suppositories, whole blood (up to 2.5%), or purulent specimens
- CE marked
CLINICAL VALIDATION
Using DNA sequencing of the HPV L1 region as the reference method, a comparative study across three provincial hospitals tested a total of 1,000 samples. After third-party adjudication of discrepant samples, the overall clinical performance was:
- Kappa value 0.94
- Sensitivity 100%
- Specificity 91%
- Positive coincidence rate 100%
- Negative coincidence rate 99.9%
- Total coincidence rate 98% (95% CI: 0.97-0.99)
Genotype-specific results:
- HPV 16: Kappa 1, sensitivity 100%, specificity 99.9%, coincidence rate 99.9%
- HPV 18: Kappa 1, sensitivity 100%, specificity 100%, coincidence rate 100%
- 12 pooled HR HPV types: Kappa 0.95, sensitivity 100%, specificity 93%, coincidence rate 98%
An additional comparison against a 27-genotype HPV assay across 200 samples showed a Kappa value of 1 and 100% total coincidence rate.
SPECIFICATIONS
- Product name: HPV 2+12 (Human Papillomavirus 2+12 Genotyping Kit)
- Catalog number: PGA1003P1
- Package size: 48 tests/kit
- Methodology: Real-time fluorescence PCR (TaqMan hydrolysis probes)
- Detection channels: FAM, HEX/VIC, ROX, CY5
- Specimen: cervical specimens collected in cell preservation solution using an endocervical brush
- Compatible instruments: open real-time PCR systems with FAM, HEX/VIC, ROX, and CY5 channels, including ABI 7500 and Roche LightCycler 480
- Specimen stability: 7 days at room temperature; 2 months at 2-8 degC; up to 6 months at -20 degC or below (no more than 5 freeze-thaw cycles)
- Reagent storage: <= -20 degC for 8 months; protect from light; no more than 5 freeze-thaw cycles; once opened, valid for 7 days at 2-8 degC
- Kit components: PCR master mix (primers, probes), positive control (plasmids with HPV 16/18/45 target fragments plus human genome), negative control (nuclease-free water)
TARGET USERS
The kit is intended for clinical laboratories, obstetrics and gynecology departments, pathology and cytology laboratories, cervical cancer screening program operators, women's health and preventive medicine centers, and molecular diagnostics providers performing HPV DNA genotyping, ASC-US triage, and co-testing with cervical cytology for cervical cancer risk stratification.