Reproductive Health
Respiratory Disease
Enterovirus
Bloodborne Infectious Diseases
MonkeyPox
Fully Automatic Instrument
Overview
AmpSure® HPV 16/18 Genotype Assay
Name
AmpSure® HPV 16/18 Genotype Assay
Feature：High Specificity | High Sensitivity | Internal Control
Detection targetHPV types 16 and 18
Specimens RequirementsHuman cervical specimens
Compatible InstrumentsAutoSAT
Specifications100 tests
Storage and Shelf LifeReagent A: 2℃ to 8℃
Reagent B: ≤ -15℃ (Amplification test Reagent
1.2 and 2.2 should be protect from light),
the validity
period is 12 months, and repeated freezing and thawing should not exceed 5
times.
CertificatesCE
Disease Damage
DNA viruses that infect mucosal and cutaneous epithelia
Sexual transmission, close contact, mother-to-child transmission
Persistent infection with high-risk HPV types is the main reason for cervical intraepithelial neoplasia
which leads to cervical cancer eventually, and HPV 16 and 18 genotypes are associated with
approximately 70% of cervical cancer and pre-cancerous cervical lesions
Advantages
CE approved
CE-IVD
Detection target
The detection target is oncogene E6/E7 mRNA of HPV types 16 and 18, reflects the trend of cervical lesions.
High specificity and sensitivity
High specificity and sensitivity, the Lo □ for HPV16 is 30 copies/reaction, while 20 copies/reaction for HPV18
Accurate Diagnosis
Can detect HPV16 and HPV18 simultaneously and discriminate between these two types
Clinical Application
Persistent HPV infection is an important cause of cervical cancer
DNA positive only indicates the presence of virus, while E6/E7 mRNA positive indicates the presence and active status of HPV infection
The overexpression of E6/E7 oncogene can be measured as E6/E7 messenger RNA (mRNA) transcripts, which is the prerequisite for the initiation and progression of cervical lesions
E6/E7 mRNA detection can be used to assess the risk of cervical lesions
Effectively reduce the overtreatment of transient HPV infection
