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A diagnostic test for Human papillomavirus genotyping (23 types) detection kit (PCR-reverse dot blot method)

A diagnostic test for Human papillomavirus genotyping (23 types) detection kit (PCR-reverse dot blot method)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020027
Enrollment
Unknown
Registered
2018-12-12
Start date
2018-12-15
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical lesion

Interventions

Gold Standard:1. Detection of human papillomavirus infection by sequencing
2. Cervical pathology results as the gold standard.
Index test:Human&#32
papillomavirus&#32
genotyping&#32
(23&#32
types)&#32
detection&#32
kit&#32
(PCR-reverse&#32
dot&#32
blot&#32
method)

Sponsors

Yaneng Biotechnology (Shenzhen) Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. women aged more than 21 years; 2. women with cervical cytologies (threshold NILM, ASC-US, LSIL, ASC-H, HSIL, AIS or malignant tumor cells) ; women with cervical histopathologies (nomal cervical epithelium, CIN, AIS or invasive cervical cancer).

Exclusion criteria

Exclusion criteria: 1. Women during pregnancy or eight weeks after delivery; 2. Women who have no sex life; 3. Women who have undergone hysterectomy or cervical resection; 4. Cervical detachment epithelial cell samples do not meet the sample requirements of the reagents being tested and the comparative reagents.

Design outcomes

Primary

MeasureTime frame
HPV DNA;Cervical histopathology;—

Countries

China

Contacts

Public ContactSun Pengming

Fujian Provincial Maternity and Children's Hospital

sunfemy@hotmail.com+86 13788873900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026