Reproductive Health
Respiratory Disease
Enterovirus
Bloodborne Infectious Diseases
MonkeyPox
Fully Automatic Instrument
Overview
AmpSure® HPV Assay
Name
AmpSure® HPV Assay
Feature：High Specificity | High Sensitivity | Internal Control
Detection targetThe high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
Specimens RequirementsHuman cervical specimens
Compatible InstrumentsAutoSAT
Specifications100 tests
Storage and Shelf LifeReagent A: 2℃ to 8℃
Reagent B: ≤ -15℃(Amplification Detection Solution 3.2 and 4.2 should be protected 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
which leads to cervical cancer eventually
Advantages
CE Approved
CE-IVD
High Sensitivity
The detection target is E6, E7 mRNA of high-risk HPV genotypes, rather than HPV DNA, it is more correlated with the severity of cervical lesions, highly sensitive to precancerous cervical lesions
Wide Coverage
Cover 14 high-risk HPV genotypes, including HPV16, 31, 35, 52, 33, 58, 56, 66, 51, 18, 45, 39, 68, 59. High sensitivity, for HPV16, 18, 31, 33, 35, 39, 45, 52, 59, 68
Sample collection
Sample collected can be used for both TCT examination and molecular testing because of the cell preservation solution used, which enable the clinical samples to be fully verified.
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
