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HPV-DNA Detectionby PCR and Typing by PCR & Sanger Sequencing - LBC
Cancer
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No Fasting Required
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Detects & types HPV DNA.
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HPV-DNA Detection by PCR and Typing by PCR & Sanger Sequencing - LBC
- Why is it done?
- Purpose of the Test: This test detects and identifies the presence of Human Papillomavirus (HPV) DNA in cervical samples collected via Liquid-Based Cytology (LBC). It uses Polymerase Chain Reaction (PCR) for highly sensitive detection and Sanger sequencing for precise viral typing to identify specific HPV strains.
- Primary Indications: Screening for high-risk HPV types associated with cervical cancer; evaluation of abnormal cervical cytology results (ASC-US, LSIL, HSIL); monitoring patients with history of HPV infection; assessing risk for cervical intraepithelial neoplasia (CIN); determining need for colposcopy or further intervention.
- Timing and Circumstances: Performed as part of routine cervical cancer screening; when Pap smear results are ambiguous or abnormal; in patients aged 21-65 years as per screening guidelines; during follow-up of known HPV-positive patients; reflex testing following abnormal cytology results.
- Normal Range
- Reference/Normal Result: HPV-DNA: NEGATIVE - No HPV DNA detected; indicates absence of HPV infection or viral load below detection threshold.
- Abnormal Results: HPV-DNA: POSITIVE - Specific HPV type(s) detected and identified. High-Risk Types: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 (associated with increased cervical cancer risk). Low-Risk Types: HPV 6, 11, 42, 43, 44, 54, 61, 70, 72, 81, 87 (typically cause benign lesions or warts).
- Units of Measurement: Qualitative (Positive/Negative); Viral typing by PCR identifies presence; Sanger sequencing provides precise genotype identification.
- Interpretation Summary: Negative result = Lower cervical cancer risk; Positive for high-risk HPV = Elevated cervical cancer risk, warrants further evaluation; Positive for low-risk HPV = Lower cancer risk but requires monitoring.
- Interpretation
- Negative HPV-DNA Result: Indicates no detectable HPV infection; suggests low risk for cervical pathology; allows for routine screening intervals (typically 5 years if combined with negative cytology); patient has minimal cervical cancer risk in the short term.
- Positive HPV 16/18 (High-Risk): Most oncogenic HPV types; highest risk for cervical cancer development; requires immediate colposcopy referral; approximately 30-40% risk of CIN 3 if HPV 16 present; warrants close surveillance and potential intervention.
- Positive Other High-Risk HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68): Significant cancer risk but lower than HPV 16/18; still warrant colposcopy evaluation; 10-25% risk of CIN 3 depending on specific type; requires monitoring and potential intervention based on cytology.
- Positive Low-Risk HPV (6, 11, 42, 43, 44, 54, 61, 70, 72, 81, 87): Lower malignant potential; more commonly associated with benign findings or genital warts; minimal cervical cancer risk (<1%); usually requires routine follow-up rather than immediate colposcopy unless cytology abnormalities present.
- Factors Affecting Results: Sample quality and adequacy; timing of collection during menstrual cycle; presence of inflammatory conditions; prior HPV vaccination status; immunosuppression; smoking history; concurrent infections; number of sexual partners; immune response status.
- Clinical Significance: HPV typing provides prognostic information beyond detection alone; combination with cytology results guides clinical management; persistent high-risk HPV infection (>12 months) indicates increased cancer risk; clearance of HPV is associated with regression of cervical lesions.
- Associated Organs
- Primary Organ System: Female reproductive system, specifically the cervix (cervical epithelium); also may involve vagina, vulva, and anogenital regions.
- Associated Medical Conditions: Cervical cancer; cervical intraepithelial neoplasia (CIN 1, 2, 3); genital warts (condyloma acuminata); recurrent respiratory papillomatosis (RRP); cervicitis; dysplasia; adenocarcinoma of cervix; squamous cell carcinoma of cervix.
- Diseases Diagnosed/Monitored: HPV infection/persistent HPV infection; cervical precancer; cervical cancer; determination of cancer risk stratification; vaccine-preventable HPV disease; monitoring post-treatment response in cervical cancer patients.
- Potential Complications: Progression to cervical cancer if high-risk HPV untreated; development of CIN if persistent infection occurs; psychological impact of positive HPV diagnosis; need for invasive procedures (colposcopy, biopsy); treatment-related complications if lesions present; potential infertility issues if cervical procedures performed.
- Follow-up Tests
- If HPV Positive for High-Risk Types: Colposcopy with possible cervical biopsy; repeat cervical cytology (Pap smear) at specified intervals; repeat HPV testing at 12 months to assess viral persistence; histopathological examination if biopsy obtained; HPV reflex testing may be performed on original LBC sample.
- If HPV Negative: Routine cervical cancer screening as per guidelines (typically every 5 years if combined with normal cytology); return to regular preventive care schedule; reassurance and counseling regarding low current risk.
- If HPV Positive for Low-Risk Types: Repeat Pap smear/cytology; HPV retest at 12 months; clinical evaluation for genital warts if symptoms present; colposcopy only if cytology abnormalities detected; reassurance regarding lower malignancy risk.
- Monitoring Frequency for Ongoing Conditions: HPV 16/18 positive: Colposcopy immediately, then follow-up per colposcopy findings; Persistent HPV: Retest at 12 months; CIN 1: Annual cytology or HPV testing for up to 2 years; Post-treatment: HPV testing at 6-12 months after treatment; Post-colposcopy: Follow-up interval determined by biopsy results.
- Related/Complementary Tests: Liquid-based cytology (ThinPrep, SurePath); conventional Pap smear; cervical histopathology (biopsy); HPV mRNA testing; p16/Ki67 immunocytochemistry; viral load quantification; E6/E7 expression testing.
- Fasting Required?
- Fasting Requirement: NO - Fasting is not required for this test. This is a cervical sample collection procedure that does not involve blood work.
- Patient Preparation Instructions: Avoid sexual intercourse for 24-48 hours prior to collection; avoid vaginal douching for 24-48 hours before test; do not use vaginal creams, lubricants, or medications for 24-48 hours before collection; avoid menstrual period collection (preferred timing is 5-20 days after start of last menstrual period); empty bladder before procedure; avoid tampons for 24 hours before collection.
- Medications to Avoid: Discontinue vaginal medications, creams, and lubricants 24-48 hours before collection; avoid spermicides; no topical antifungal creams; do not use hormone-containing vaginal preparations for 24-48 hours prior to test.
- Other Special Instructions: Schedule appointment at least 5 days after end of menstruation; inform provider of abnormal symptoms or bleeding; disclose current medications and supplements; provide accurate reproductive history; note any recent gynecological procedures; be prepared to discuss symptoms or concerns with healthcare provider; sample must be collected by qualified healthcare professional in appropriate clinical setting.
How our test process works!

