GENTECH DIAGNOSTICS PVT. LTD.- HPV DNA Test Kit HBV DNA Quantification Test  Kit CMV DNA Quantification Test  Kit Real Time PCR HBV DNA Quantification  Real Time PCR HBV DNA GenotypeColposcope Digital Imaging System

The HPV DNA is a semi-quantitative test (1,000 copies/ml cut-off) that uses RNA probes specific for full-length HPV genomes of the 13 viral types responsible for the pathogenesis of High-grade cervical disease and invasive cancer – HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68.
 

• A high level of diagnostic confidence over equivocal and abnormal Pap smears, and determining the risk of progression to more severe disease, as well as predicting disease recurrence post treatment.
• Minimizes any risk of missed cervical disease.
• Determines the need for colposcopy by identifying women at greatest risk of missed disease or subsequent development of disease versus those at virtually no risk.
• Provides more immediate results than repeat cytology (Pap smears) and enables HPV negative women to be followed up at a longer intervals ranging 5 to 10 years. If positive for high risk lesion, women could be followed up annually, while with low-grade lesion, women could followed up every three years.
   

Specimen Collection and Transportation Protocols
 

Cervical specimens for Digene HC II HPV DNA Test or CT/GC DNA or CT-ID Test or GC-ID Test to be collected with Cervical Sampler Kit*.
(Collect specimen for prior to application of acetic acid or iodine, if any colposcopy will be performed.)
Kit* contains 1 pre-scored cervical brush & 1 tube containing Specimen Transport medium. Remove excess mucus from cervical os and surrounding ectocervix using a clean cotton or Dacron swab.
Insert the brush 1 to 1.5 mm into the os of the cervix until the largest outer bristles touch the ectocervix.
Rotate 3 full turns in a counter-clockwise direction
Remove the brush from the canal avoid touching any object
Place the brush to the bottom of the transport tube, snap off shaft of the Sampler at the score line and cap tube securely. 1.0 ml of Specimen Transport Medium provided in the specimen collection kit
2 to 300 C for 2 weeks or –200C for longer duration 2-300C. To prevent tube caps from popping off, specimen tube caps to be firmly covered with Para film
Cervical Swab specimens for Pap Smear prior to Digene HC HPV DNA Test or CT/GC DNA or CT-ID Test or GC-ID Test to be collected with Female Swab Specimen Collection Kit*.
(Collect specimen for prior to application of acetic acid or iodine, if any colposcopy will be performed.)
Kit* contains 1x2 Dacron Swabs & 1 tube containing Specimen Transport medium. Insert Female Swab into endocervical canal and rotate it through 1800 turns 5 times alternately in opposite directions.
Rub swab firmly over the entire transformation zone.
Withdraw swab carefully avoiding contact with vaginal mucosa.
Place swab to the bottom of the transport tube. Snap off shaft at the score line, cap tube firmly & wrap Para film around the neck. 1.0ml of Specimen Transport Medium provided in the Specimen Collection Kit 2 to 300 C for 2 weeks or –200C for longer duration 2-300C. To prevent tube caps from popping off, specimen tube caps to be firmly covered with Para film
Cervical Biopsies for Digene HC HPV DNA Test or CT/GC DNA or CT-ID Test or GC-ID Test to be collected with Female Swab Specimen Collection Kit or Cervical Sampler Kit. 5mm in cross section, to be placed into the Digene Transport Medium.
(Cervical biopsies processed with histological fixatives cannot be used for Digene tests) 1.0 ml of Specimen Transport Medium provided in the specimen collection kit -200C Shipped at 2-300C for overnight delivery to the lab for testing.
Male Urine specimen for Digene CT/GC DNA or CT-ID Test or GC-ID Test.
Urine Preparation Kit is recommended by Digene Collect urine specimen in a sterile preservative free collection cup from male patients who have not urinated within 1 hour prior to collection. 20-30ml of first time stream 2-80C In coolant gel packs and thermo Cole with 24 hrs of collection time by testing lab.