HPV-DNA Detectionby PCR and Typing by PCR & Sanger Sequencing - Vaginal swab

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Detects & types HPV DNA.

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HPV-DNA Detection by PCR and Typing by PCR & Sanger Sequencing - Vaginal Swab

Why is it done?
- Test Purpose: This test detects and identifies Human Papillomavirus (HPV) DNA in vaginal samples using highly sensitive polymerase chain reaction (PCR) technology, followed by genotype identification through Sanger sequencing.
- Primary Indications: Cervical cancer screening and risk stratification
- Detection of high-risk HPV types (including HPV-16, HPV-18, and other oncogenic strains)
- Identification of low-risk HPV types associated with benign lesions
- Triage of cytologically abnormal Pap smear results (ASC-US, LSIL)
- Monitoring for persistent or recurrent HPV infection
- Post-treatment surveillance following cervical lesion procedures (LEEP, cone biopsy)
- Evaluation of abnormal pelvic imaging or colposcopy findings
- Typical Timing: Typically performed during routine gynecological examination, preferably 5 days after the end of menstruation, or as part of primary cervical cancer screening protocols
Normal Range
- Normal Result: Negative (No HPV-DNA detected)
- Abnormal Result: Positive (HPV-DNA detected with specific genotype identification)
- Units of Measurement: Qualitative (Presence/Absence of HPV-DNA); Genotype identification (specific HPV type classification)
- Negative Result Interpretation: No detectable HPV-DNA; indicates absence of HPV infection or viral load below detection threshold; low risk for cervical cancer development
- Positive Result Interpretation: HPV-DNA detected with genotype specified; risk level depends on HPV type (high-risk vs. low-risk strains)
- High-Risk HPV Types: HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68 (associated with increased cervical cancer risk)
- Low-Risk HPV Types: HPV-6, HPV-11, HPV-40, HPV-42, HPV-43, HPV-44, HPV-53, HPV-54, HPV-61, HPV-70, HPV-72, HPV-81 (associated with benign lesions; low cervical cancer risk)
Interpretation
- Negative HPV Result: Indicates no active HPV infection; excellent negative predictive value for high-grade cervical lesions; routine screening can continue at standard intervals (typically 3-5 years); may provide reassurance if prior abnormal Pap result
- Positive for High-Risk HPV (e.g., HPV-16, HPV-18): Indicates significant risk for cervical cancer; warrants immediate referral for colposcopy; may prompt HPV vaccination counseling for contacts; requires close clinical follow-up and possible repeat testing or tissue biopsy
- Positive for Low-Risk HPV (e.g., HPV-6, HPV-11): Indicates benign HPV infection; low risk for malignancy; associated with warts or benign epithelial lesions; routine follow-up with continued screening; most infections spontaneously clear within 1-2 years
- Multiple HPV Types Detected: Suggests concurrent infection with multiple HPV strains; risk stratification based on presence and types of high-risk strains identified; requires comprehensive clinical assessment
- Persistent Infection: Detection of same HPV type on repeat testing over 6-12 months indicates persistence; significantly increases risk for precancerous changes; requires more aggressive management and surveillance
- Factors Affecting Results: Specimen quality and collection technique, timing within menstrual cycle, recent sexual activity, smoking history, immunosuppression status, age at first sexual contact, number of sexual partners
- Clinical Correlation: HPV test results must be interpreted alongside cytology (Pap smear), colposcopy findings, and clinical examination for optimal cervical cancer risk assessment and management decisions
Associated Organs
- Primary Organ System: Female reproductive tract, specifically the cervix (cervical epithelium); vagina and lower genital tract also affected
- Diseases and Conditions Associated with Abnormal Results: Cervical intraepithelial neoplasia (CIN I, II, III), cervical cancer, genital warts (condyloma acuminata), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), recurrent respiratory papillomatosis (RRP)
- HPV-Associated Cancers: Cervical cancer (most common), anal cancer, oropharyngeal cancer, penile cancer, vulvar cancer, vaginal cancer; HPV-16 and HPV-18 responsible for approximately 70% of all cervical cancers worldwide
- Potential Complications: Progression from persistent infection to precancerous lesions (dysplasia), invasion through cervical epithelium with potential metastasis, psychological distress from positive HPV diagnosis, reproductive complications if cervical interventions required
- Risk Factors for Severe Disease: HIV infection or other immunosuppression, smoking, early age at first sexual intercourse, multiple sexual partners, prior abnormal Pap smears, history of sexually transmitted infections
- Natural History: Most HPV infections (80-90%) clear spontaneously within 1-2 years; persistent high-risk HPV infection carries 30% risk of developing precancerous lesions within 5 years if untreated
Follow-up Tests
- If Negative HPV Result: Routine cervical cancer screening at standard intervals (every 3-5 years or per guidelines); concurrent Pap smear for optimal screening strategy; HPV vaccination if age-appropriate and not previously vaccinated
- If Positive for High-Risk HPV: Liquid-based cytology (Pap smear) or reflex cytology, colposcopy with directed cervical biopsy, cervical biopsy if colposcopic findings warrant, HPV 16/18 genotype confirmation for risk stratification
- If Positive for Low-Risk HPV: Concurrent Pap smear for cytologic assessment, routine follow-up at 12 months, colposcopy only if concurrent cytologic abnormalities present, evaluation for external genital warts
- Post-Treatment Surveillance: HPV retesting at 6-12 months post-excisional procedure (LEEP, cone biopsy), follow-up Pap smear in conjunction with HPV testing, colposcopy if HPV remains positive or cytology abnormal
- Monitoring Frequency: High-risk HPV positive: repeat testing at 12 months if normal cytology; annual screening for 3 years after abnormal finding; persistence testing at 6-month intervals if indicated
- Complementary Tests: P16/Ki-67 immunocytochemistry, E6/E7 mRNA testing, HPV E6/E7 protein detection, comprehensive sexually transmitted infection screening, HIV testing (in appropriate populations)
- Additional Investigations: Pelvic ultrasound if concerning features present, MRI for staging if cervical cancer suspected, immunohistochemistry studies on biopsy specimens, molecular testing for viral load assessment
Fasting Required?
- Fasting Requirement: No - Fasting is NOT required for this test. This is a vaginal swab specimen collection procedure that does not involve blood drawing or systemic testing.
- Pre-Test Instructions: Avoid sexual intercourse 24-48 hours before specimen collection for optimal results
- Avoid vaginal douching 48 hours prior to collection
- Do not use vaginal creams, lubricants, or spermicides within 48 hours of collection
- Avoid menstrual period if possible; optimal collection is 5 days after menstruation ends
- Schedule appointment at least 5 days after completion of menstrual period if clinically feasible
- Medications: No medications need to be avoided for this test; continue all regularly prescribed medications as directed
- Additional Specimen Collection Instructions: Collect specimen using sterile swab and transport medium according to laboratory protocol; preserve sample in appropriate fixative or transport medium; ensure proper labeling with patient identifiers
- Sample Type: Vaginal swab or cervical brush specimen in liquid-based cytology medium or viral transport medium; approximately 2-3 mL of sample volume recommended

How our test process works!