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HPV Genotyping (16, 18 & 45 genotypes) by RT PCR

Cancer
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Detects & types HPV DNA.

₹2,664₹3,806

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HPV Genotyping (16/18 & 45 genotypes) by RT PCR - Comprehensive Medical Test Guide

  • Section 1: Why is it done?
    • Test Overview: This test uses Reverse Transcription PCR (RT-PCR) technology to detect and identify specific high-risk Human Papillomavirus (HPV) genotypes, particularly HPV-16, HPV-18, and HPV-45, which are the most oncogenic strains associated with cervical and anogenital cancers.
    • Primary Indications: Reflex testing following abnormal cervical cytology (Pap smear results); risk stratification in women with borderline or mildly abnormal Pap results; triage of patients with ASCUS (Atypical Squamous Cells of Undetermined Significance); assessment of high-risk HPV status in cervical screening programs; evaluation of persistent HPV infection; surveillance of immunocompromised patients.
    • Clinical Circumstances: Performed when Pap smear results show abnormalities; part of HPV co-testing in primary cervical cancer screening; follow-up evaluation after colposcopy; assessment prior to HPV vaccination; post-treatment surveillance; evaluation of immunocompromised or HIV-positive women.
    • Specimen Requirements: Cervical cells typically obtained using liquid-based cytology (LBC) techniques; endocervical brush or broom used for collection; sample placed in appropriate transport media for RT-PCR analysis.
  • Section 2: Normal Range
    • Normal Result: Negative for HPV-16, HPV-18, and HPV-45; reported as 'HPV-16/18/45 Not Detected'; indicates absence of detectable high-risk HPV genotypes in the specimen.
    • Abnormal Results: Positive for one or more high-risk genotypes; reported as 'HPV-16 Detected,' 'HPV-18 Detected,' 'HPV-45 Detected,' or combinations thereof; results may show single genotype or multiple concurrent infections.
    • Units of Measurement: Qualitative presence/absence; may include semi-quantitative viral load measurement (copies/mL) in some laboratory protocols; cycle threshold (Ct) values may be reported to indicate viral burden.
    • Interpretation Guidelines: Negative result = Low cancer risk in immediate timeframe; Positive result = High-risk genotype present, requires clinical follow-up; HPV-16 = Highest oncogenic potential; HPV-18 = Associated with adenocarcinoma; HPV-45 = Significant cancer risk; co-infections indicate increased risk profile.
    • Quality Control: Results must include internal control validation to ensure specimen adequacy; samples with failed internal controls should be recollected; test sensitivity typically >95%; specificity >99%.
  • Section 3: Interpretation
    • HPV-16 Detection: Indicates presence of most oncogenic HPV type; associated with highest risk of cervical squamous cell carcinoma, adenocarcinoma, and anogenital cancers; requires immediate colposcopic evaluation if accompanying abnormal cytology; warrants closer surveillance intervals; consider for HPV vaccination if previously unvaccinated.
    • HPV-18 Detection: Indicates presence of HPV type strongly associated with adenocarcinoma and adenosquamous carcinomas of the cervix; carries high malignant potential; requires clinical follow-up and possible colposcopy; adenocarcinomas may develop with minimal cytologic changes; heightened surveillance recommended.
    • HPV-45 Detection: Indicates presence of another significant oncogenic genotype; also associated with adenocarcinoma; requires clinical follow-up similar to HPV-18; considered part of high-risk category; warrants careful surveillance protocols.
    • Negative HPV Result (ASCUS Cytology): Reassuring finding suggesting lower risk for high-grade dysplasia; can return to routine screening intervals; reduces immediate colposcopy referral need; has excellent negative predictive value for cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3).
    • Multiple Genotype Detection: Indicates co-infection with multiple high-risk types; carries cumulative cancer risk; management should follow the most aggressive genotype detected; may indicate exposure to multiple viral strains or reactivation of latent infections.
    • Factors Affecting Results: Specimen adequacy and cellularity; timing of menstrual cycle; presence of lubricants or contraceptive creams; recent sexual activity; immune status of patient; smoking history; oral contraceptive use; previous HPV exposure or vaccination status; specimen storage conditions; DNA/RNA integrity during transport.
    • Transient vs. Persistent Infection: Single positive result may represent transient infection clearing within 1-2 years; persistent detection at repeat testing (6-12 months) indicates true persistent infection with higher cancer risk; persistent HPV-16/18 infections warrant more aggressive management.
  • Section 4: Associated Organs
    • Primary Organ System: Female reproductive tract, specifically the cervix; includes squamocolumnar junction where dysplastic changes typically originate; extends to include anogenital tract including vulva, vagina, anus, and perianal tissues.
    • Associated Conditions - Cervical: Cervical intraepithelial neoplasia (CIN) grades 1-3; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous carcinoma; benign cervical polyps; cervicitis; chronic cervical inflammation.
    • Associated Conditions - Anogenital: Vulvar intraepithelial neoplasia (VIN); vaginal intraepithelial neoplasia (VaIN); anal intraepithelial neoplasia (AIN); vulvar cancer; vaginal cancer; anal cancer; anogenital warts (condyloma acuminatum); recurrent respiratory papillomatosis in affected offspring.
    • Associated Conditions - Other Sites: Oropharyngeal cancers; laryngeal papillomatosis; conjunctival tumors; nasopharyngeal lesions; potential involvement in male urogenital tract and anogenital cancers.
    • Complications Associated with Positive Results: Progressive dysplasia leading to invasive cancer; increased anxiety and psychological burden; need for more frequent surveillance; potential surgical interventions including cone biopsy, loop electrosurgical excision procedure (LEEP); reproductive complications from cervical procedures; systemic spread of cancer if advanced; impact on fertility and future pregnancies.
    • Special Populations: Immunocompromised women (HIV+, transplant recipients) at higher risk for rapid progression; pregnant women requiring modified management strategies; post-menopausal women with different screening recommendations; women with prior cervical procedures or hysterectomy.
  • Section 5: Follow-up Tests
    • Immediate Follow-up for Positive HPV-16/18/45: Colposcopy with directed biopsies; review of concurrent Pap smear findings; cervical biopsy for histologic grading if dysplasia suspected; assessment of entire lower anogenital tract; documentation of findings using Bethesda classification system.
    • Diagnostic Tests: Cervical biopsy for CIN grading; endometrial biopsy if adenocarcinoma suspected; imaging studies (ultrasound, MRI, CT) if advanced disease indicated; HPV mRNA testing (E6/E7) to assess oncogenic activity; p16/Ki-67 immunohistochemistry to confirm dysplasia.
    • Surveillance Following Treatment: HPV co-testing at 12 months post-treatment; repeat Pap smear 3 months after treatment; colposcopy at 4-6 months post-procedure; annual screening for at least 25 years; if HPV persists post-treatment, return to colposcopy; HPV clearance indicates improved prognosis.
    • Long-term Monitoring Frequency: Negative HPV-16/18/45 with normal cytology: Return to routine screening (3-5 years); Positive HPV with CIN1: Repeat HPV testing in 12 months or consider excisional procedures; Positive HPV with CIN2/3: Immediate excisional treatment; Persistent HPV: More frequent surveillance intervals (6-12 months); Post-treatment monitoring: Annual screening indefinitely.
    • Complementary Testing: Repeat HPV genotyping at follow-up intervals; conventional Pap smear or liquid-based cytology; HPV viral load quantification; testing for additional HPV genotypes (26, 31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) if extended genotyping available; serology for HPV antibodies in vaccination evaluation.
    • Special Circumstances Testing: For HIV+ patients: More frequent HPV testing and surveillance; earlier colposcopy referral thresholds; testing of additional anogenital sites; immunologic status assessment (CD4 count); For immunosuppressed patients: Intensified screening protocols; consideration of anogenital cancer surveillance.
    • Vaccination Considerations: HPV vaccination status assessment; consideration of HPV vaccination even after diagnosis (may prevent other genotypes); vaccinated individuals still require same screening protocols; testing post-vaccination to assess immunity if indicated.
  • Section 6: Fasting Required?
    • Fasting Requirement: No - Fasting is NOT required for HPV genotyping by RT-PCR.
    • Patient Preparation: Do NOT apply vaginal douches, lubricants, or contraceptive creams for 24 hours before specimen collection; avoid menstrual period if possible, collect during follicular phase for optimal results; abstain from sexual intercourse for 24-48 hours prior to collection if possible; empty bladder before examination for patient comfort.
    • Specimen Collection Instructions: Endocervical brush or broom inserted into endocervical canal; rotate 5-10 times or until bristles are no longer visible; liquid-based cytology medium collection in appropriate transport media; proper labeling with patient identification; specimen stability maintained per laboratory protocol; transport to laboratory within specified timeframe.
    • Medications - No Restrictions: Regular medications may be continued normally; no need to discontinue any medications for this test; hormonal contraceptives do not interfere; antibiotics should not affect HPV detection accuracy.
    • Pre-examination Timing Considerations: Collect outside menstrual period if possible; avoid heavy menstrual bleeding which may obscure findings; collection during follicular phase (days 7-21 of cycle) preferred for clearer results; post-menopausal women have no timing restrictions; timing relative to sexual activity important (24-48 hour abstinence recommended).
    • Additional Notes: This is an office-based procedure typically done during regular gynecologic examination; minimal patient discomfort; no sedation required; results typically available within 3-7 business days depending on laboratory; patients should be informed of results by healthcare provider; positive results warrant prompt follow-up discussion and management planning.

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