QUALITATIVE TEST FOR HIGH RISK HUMAN PAPILLOMA VIRUS BY RT-PCR

VIRUS DETECTION: Human Papilloma Virus (HPV)

INDICATIONS FOR ORDERING: Screening test of cervical cancer to detect the presence of HPV and triaging patients with equivocal cytology. Further, useful in monitoring vaccine efficacy, and in post-therapy follow-up cases. Molecular detection of high risk HPV improves the cost effectiveness and efficiency of screening programmes for cervical carcinoma.

METHOD USED: Real time qualitative polymerase chain reaction using kits provided by 3B Blackbio Biotech India Pvt Ltd (TRUPCR HPV HR WITH 16/18 GENOTYPING KIT)

SPECIMENS – Type, storage and transport

• Type: Cervical tissue/cytology slides/cervical swab
• Transport: Specimens must be received within 48 hours of collection
• Extracted DNA: Separate specimens must be submitted when multiple tests are ordered.

TEST DESCRIPTION: This is a DNA-based real-time PCR assay. DNA extracted is amplified in Real Time PCR and detected using fluorescent reporter dye probes specific for 14 HPV genotypes (16/18/31/33/35/39/45/51/51/56/58/59/66 and 68).

ANALYTICAL SENSITIVITY: This assay can detect the presence of HPV at the level of 100 IU/ml

TURNAROUND TIME: 3 (three) working days from receipt of sample

QUALITY ASSURANCE & COMPETENCY TESTING: Regular internal quality checks and intro-lab comparisons are performed to ensure accurate and precise results. Highly trained personnel performing this test undergo regular competency assessments and attend regular conferences and educational programs in order to stay upbeat with the newer advances in the biology and diagnostics of the disease in question.

ACCREDIATION: NOT IN NABL SCOPE

NOTE : Kindly note that this test does not yield the copy numbers of the genotypes detected and hence is not recommended for monitoring of molecular measurable residual disease. This is a screening test which detects the infection caused by HPV