SAT Platform TechnologyProduct Information
AmpSure® HPV 16/18 Genotype Assay
Name AmpSure® HPV 16/18 Genotype Assay
Feature:High Specificity | High Sensitivity | Internal Control
Detection target

HPV types 16 and 18

Specimens Requirements

Human cervical specimens

Compatible Instruments



100 tests

Storage and Shelf Life

Reagent 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.



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

CE approved
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

Contact Information



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