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This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urine Specimen | Experimental |
| |
| Cervical Swab Specimen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Diagnostic Kit (Bio Farma) | Diagnostic Test | Urine samples (30 ml): collected from each subjects using urine pot. Cervical swab: collected from each subject using cyto brush and stored in special container which preservatives fluid. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample | Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma) | 0 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |