text.skipToContent text.skipToNavigation

digene HPV Genotyping PS Test

For HPV genotyping of HC2 positive samples

  • Individual detection of HPV types 16, 18, and 45
  • Highly specific RNA probes for each genotype
  • Clinically proven Hybrid Capture 2 technology
  • Qualitative test results
  • Full compliance with EU IVD Directive 98/79/EC
The digene HPV Genotyping PS Test is a reflex test intended of the qualitative detection of high-risk HPV types 16, 18, and 45 following a positive digene HC2 High-Risk HPV DNA Test result. The identification of high-risk HPV types 16, 18, and 45 provides additional information to aid in the clinical management of women in cervical cancer screening programs.
Cat No./ID: 613615
digene HPV Genotyping PS Test
$812.00
Add To Cart
For 96 reactions, includes: primers, reagents, buffers and accessories using Hybrid Capture 2 (HC2) technology

The digene HPV Genotyping PS Test is intended for in vitro diagnostic use.


0

CE-IVD marked.

Performance

The digene HPV Genotyping PS Test is CE-IVD marked for in vitro diagnostic use.

The digene HPV Genotyping PS Test showed high test result agreement in identifying HPV types 16, 18, and 45 in comparison with a validated quantitative PCR HPV Genotyping test. The comparison included 287 PreservCyt and 290 STM archived cervical specimens obtained from a routine screening population. The digene HC2 High-Risk HPV DNA Test result was determined for each specimen prior to inclusion in the study. The results of the digene HC2 High-Risk HPV DNA Test were 238 positive and 52 negative STM specimens and 237 positive and 50 negative PreservCyt specimens. Each specimen was tested for HPV 16, 18, and 45 separately, with both the digene HPV Genotyping PS Test and the qPCR. The total agreement between the digene HPV Genotyping PS Test and the qPCR method was 99.4% (see table).

Agreement between the digene HPV Genotyping PS Test and the qPCR test method 
digene HPV Genotyping PS Test
+
qPCR + 110 4
qPCR – 7    1610
Total agreement was 99.4%, with a 95% CI of 98.9–99.6%. Each sample was tested in triplicate, with 1720 of 1731 samples showing agreement. 

The test agreement of the digene HPV Genotyping PS Test to the qPCR test was determined based on the HPV genotype (see table).

Test result agreement of the digene HPV Genotyping PS Test and the qPCR test for HPV genotype
GenotypeAgreement% (n/N) 95% CI
HPV 16 99.1% (572/577) 98.0–99.6
HPV 18 99.7% (575/577) 98.7–99.9
HPV 45 99.3% (573/577) 98.2–99.7
The test result agreement of the digene HPV Genotyping PS Test to the qPCR test was determined based on the specimen type, with STM specimens showing 99.8% agreement with a 95% CI of 99.2–99.9 and PreservCyt specimens showing 99.0% agreement with a 95% CI of 98.0–99.4.

 Using the digene HPV Genotyping PS Test offers analytical specificity with no cross-reactivity between the 3 HPV probe mixes and the following HPV plasmid DNA:

High-risk HPV types 16, 18, 26,  31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82

Low-risk HPV types 1, 2, 3, 4, 5, 6, 8, 11, 13, 30, 34, 40, 42, 43, 44, 67, 69, 70, and 71

Principle

The digene HPV Genotyping PS Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of the 3 high-risk types of HPV DNA in cervical specimens. The assay is intended as a reflex test to a positive digene HC2 High-Risk HPV DNA Test result, to determine the presence or absence of 16, 18, or 45 genotypes.

 HPV types 16, 18, and 45 are the most commonly found high-risk HPV types associated with squamous cell carcinoma and adenocarcinoma. A recent study of HPV genotypes shows that invasive cervical cancers which are related to HPV types 16, 18, and 45 are diagnosed on average 4 years earlier than cervical cancers associated with other high-risk HPV types. (de Sanjose, S. et al. (2010) Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet 11, 1048.)

Samples collected with the digene Cervical Sampler may be used with the digene HPV Genotyping PS Test.

Procedure

The digene HPV Genotyping PS Test utilizes the familiar format of Hybrid Capture 2 (HC2) chemistry, using type-specific oligoribonucleotides, antibody capture, and qualitative chemiluminescent signal detection.

The digene HPV Genotyping PS Test, performed in triplicate for each cervical specimen, genotypes for 3 high-risk types (16, 18, and 45) of HPV DNA in cervical specimens. After denaturation, specimens are hybridized with specific HPV RNA probes which target the full HPV genome. The resultant RNA:DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. In the digene HPV Genotyping PS Test, the formation of hybrids and their subsequent capture onto the surface of the microplate occur simultaneously during a single step. Immobilized hybrids then react with specific alkaline phosphotase-conjugated and are detected with a chemiluminescent substrate using the DML 2000 or DML 3000 instrument.

Applications
The digene HPV Genotyping PS Test is a reflex test intended for the qualitative detection of high-risk HPV types 16, 18, and 45 following a positive digene HC2 High-Risk HPV DNA Test result. The digene HPV Genotyping PS Test may be used for testing women in cervical cancer screening programs.

You are not authorized to download the resource

fragment fix placeholder

Customers who bought these products also bought