1,detect 14 high-risk HPV types 2,HPV 16 & 18 3, compatible with PCR instruments 4,HPV internal control 5,DNA extraction
The facts you should know .
1. In cervical cancer up to 99.7% of cases are associated with HPV infection.(1)
2. Persistent infections with high-risk HPVs are the primary cause of cervical cancer and anal cancer.(2)
3. HPV types 16 and 18.,these two types of HPV together cause about 70 % of all cases of cervical cancer (3)
Pap tests is a good way to protect women against cervical cancer, but it's not enough, because, (4)
1. The sample does not contain abnormal cells which may be present on the cervix.
2. Some samples are hard to interpret. For example, blood or mucus may make it hard to see the cells.
3. Occasionally, abnormal cells are missed under the microscope.
4. Sometimes abnormal cells occur in cells high up in the cervix or deep in the glands of the cervix (adenocarcinoma). It is not always possible to get samples from these areas.
The co-testing with Pap cytology and HPV testing could be the best way to know the risk
1. HPV and Pap Co-Testing Safely Extend Cervical Cancer Screening Intervals. (5)
2. Incorporating HPV testing with cytology also resulted in earlier identification of women at high risk of cervical cancer, especially adenocarcinoma. Testing for HPV without adjunctive cytology might be sufficiently sensitive for primary screening for cervical cancer. (6)
The guidelines from ASCCP
The detail of HPV16 and 18
1. HPV 16 and 18 are the two most prevalent oncogenic HPV types in both squamous cell carcinoma and adenocarcinoma, and account for approximately two-thirds of all cervical cancer cases.(7)
2. Distinguishing HPV 16 and 18 from other high-risk HPV types may identify women at the greatest risk of ≥CIN3.(8)
Quick-dot® Human papillomavirus Test
Two type (I and II) now is available
Features:
1.Simultaneously detects 14 high-risk HPV types
2.Provides specific pooled information for HPV16 and 18 (only for Type II)
3.ß-globin from cellular input is used as an internal control to assess specimen quality and identify specimens containing factors that inhibit the amplification process.
4.This assay is compatible with the most of realtime PCR instruments.
5. The DNA extraction reagent is included with dramatical easy protocol.
Intended use:
This test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. One test can detect 14 high-risk (HR) HPV types by Polymerase Chain Reaction (PCR) and fluorescence labeled ribonucleic acid probe with realtime PCR instruments.
Data from clinical trail:
1. Specimen co-infected group1(pooled HPV16 and HPV18 and 2.(other 12 pooled hrHPV)
2. Specimen only infected group1
3. Specimen only infected group 2
4. Negative Specimen
5. Quick-dot® Human papillomavirus Test (Q) compare to competitor H (pooled 13 hrHPV test ,approved by FDA)
Total 200 clinical specimens from Jiangsu, PRC included in the test.
The algorithm of test process
Quick Dot---Human Papilloma Virus(HPV) Screening Test Reagents 24T/box (HPV) serum Dot Rapid Assay Kit
