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ICA2309-1
BioTeke
A.Intended Use
Used for qualitative detection of HPV in human urine samples,providing auxiliary diagnostic information for physicians.Health screening applicable to the female population.
Based on the principles of cellular metabolism,achieve the diagnosis of ultra early and other stages of cervical cancer,and achieve full monitoring of cervical cancer.Provide new means for cervical cancer screening ,so as to significantly reduce the incidence rate and mortality of cervical cancer.
B. Test Principle
After women are infected with HPV virus, it causes cytopathic changes.The metabolites produced by the affected cells enter the urine along with epithelial cells and exfoliated cells,and areeliminated with the urine.
Viruses in the reproductive system can infect the urinary system through their own secretions, sexual activities, etc, causing cell lesionsin both male and female urinary systems, and metabolites of the affected cells will also be eliminated with urine.The concentration of metabolic substancesin the urine caused by HPV virus can reftect the severity ofthe patient's condition.
C.Product Details
a. Test Specimen :Urine
b. Sensitivity :99.33%
c. Accuracy : 98.00%
d. Specificity:99.16%
e. Reading Time : 10-15 min
D.Package Components
1 Test/Kit
a. Test Card
b. Urine Sampling Cup
c. User Manual
E.Advantages
a. Higher sensitivity, earlier detection of infection and earlier treatment;
b. Higher accuracy than similar product staining solutions on the market;
c. Higher resistance to vitamin C interference than similar products staining solutions on the market;
d. Less affected by uric acid and protein than similar products on the market.
F. Test Procedure & Reference Interval
Colorless or yellow is negative ; Light blue or grayish blue is weakly positive ; Blue green or blue is positive.
G. Product Qualifications
CE Certification - AEMPS Registration Letter |
CE Certification - AEMPS Registration Prove |
CE Certification - EC Declaration of Conformity |
CE Certification - EAR Certificate of Notification |
F. Related HPV Test Products
HPV Genotyping Detection Kit(Fluorescene PCR Method)
A.Intended Use
Used for qualitative detection of HPV in human urine samples,providing auxiliary diagnostic information for physicians.Health screening applicable to the female population.
Based on the principles of cellular metabolism,achieve the diagnosis of ultra early and other stages of cervical cancer,and achieve full monitoring of cervical cancer.Provide new means for cervical cancer screening ,so as to significantly reduce the incidence rate and mortality of cervical cancer.
B. Test Principle
After women are infected with HPV virus, it causes cytopathic changes.The metabolites produced by the affected cells enter the urine along with epithelial cells and exfoliated cells,and areeliminated with the urine.
Viruses in the reproductive system can infect the urinary system through their own secretions, sexual activities, etc, causing cell lesionsin both male and female urinary systems, and metabolites of the affected cells will also be eliminated with urine.The concentration of metabolic substancesin the urine caused by HPV virus can reftect the severity ofthe patient's condition.
C.Product Details
a. Test Specimen :Urine
b. Sensitivity :99.33%
c. Accuracy : 98.00%
d. Specificity:99.16%
e. Reading Time : 10-15 min
D.Package Components
1 Test/Kit
a. Test Card
b. Urine Sampling Cup
c. User Manual
E.Advantages
a. Higher sensitivity, earlier detection of infection and earlier treatment;
b. Higher accuracy than similar product staining solutions on the market;
c. Higher resistance to vitamin C interference than similar products staining solutions on the market;
d. Less affected by uric acid and protein than similar products on the market.
F. Test Procedure & Reference Interval
Colorless or yellow is negative ; Light blue or grayish blue is weakly positive ; Blue green or blue is positive.
G. Product Qualifications
CE Certification - AEMPS Registration Letter |
CE Certification - AEMPS Registration Prove |
CE Certification - EC Declaration of Conformity |
CE Certification - EAR Certificate of Notification |
F. Related HPV Test Products
HPV Genotyping Detection Kit(Fluorescene PCR Method)
Telephone/Whatsapp: +86 18115363743
Email : zr@bioteke.cn