RealLine HPV 16 / 18

Clinical information:

Human Papilloma Viruses HPV are DNA-Viruses and more than 100 different types are known. While the majority of HPVs cause no symptoms, some can cause low severe symptoms like warts and a few are known to cause cancer. HPV types that are more likely to lead to the development of cancer are referred as high-risk types HPV. High-risk HPV-types are known to cause the vast majority of cervical cancers which cause death in women with an annual incidence of around half a million and a mortality of almost 50 %. HPV 16 and 18 types are the most prevalent high carcinogenic risk types.

The extraction of DNA from clinical materials can be performed using the extraction kits:

• RealLine DNA-Express (REF VBC8899-R)
• RealLine Extraction 100 (REF VBC8896-R)
• INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany)
• INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany)
• VeriLab UMag (Laboveritas SIA)

When using DNA extraction kits of other manufacturers, it necessary to use Internal Control sample (IC) (VBC8881, BIORON Diagnostics).

RealLine HPV 16 / 18 assay kit is intended for differential detection of DNA of human papillomavirus (HPV) types 16 and 18 DNA in clinical specimens (epithelial cell swabs) using the method of realtime polymerase chain reaction (PCR) with fluorescence detection of amplified product.

The results of PCR analysis are taken into account in complex diagnostics of disease.

The Str-Format Kit contains 96 tubes (0.2 ml) in strips with lyophilized Mastermix. 50 μl of extracted DNA have to be pipetted into the tube and the ready Mastermix is diluted. The kit contains reagents required for 96 tests, including control samples and the positive control sample.

The kit is validated for use with: iQ™5 iCycler (Bio-Rad, USA, iQ™ iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNA-Technology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).

The use of:

!  Extraction Kits for nucleic acids from clinical specimen from other supplier

!  other real-time PCR devices

!  appropriate reaction volumes, other than 50 µl

has to be validated in the lab by the user. The special notes regarding the internal control IC have to be strongly followed.

CE IvD

RealLine DNA-Express (REF VBC8899-R)

RealLine Extraction 100 (REF VBC8896-R)

INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany)

INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany)

VeriLab UMag (Laboveritas SIA)

The kit is validated for use with: iQ™5 iCycler (Bio-Rad, USA, iQ™ iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNA-Technology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).

Sensitivity

Sensitivity of HPV 16 DNA detection is determined on five samples prepared from HPV 16 DNA Standard Reference Sample with HPV 16 DNA content 100 copies per sample - 100%.

Sensitivity of HPV 18 DNA detection is determined on five samples prepared from HPV 18DNA Standard Reference Sample with HPV 18 DNA content 100 copies per sample - 100%.

Specificity

Specificity of HPV 16 DNA detection is determined on five samples prepared from HPV 18 DNA Standard Reference Sample with HPV 18 DNA content 100 copies per sample - 100%.

Specificity of HPV 18 DNA detection is determined on five samples prepared from HPV 16 DNA Standard Reference Sample with HPV 16 DNA content 100 copies per sample - 100%.

Diagnostic evaluation

Diagnostic sensitivity of detection of DNA of human papillomavirus types 16 and 18: clinical trials conducted on 92 positive samples showed 100% sensitivity (interval 96.8% -100%, with a confidence level of 90%).

Diagnostic specificity of detection of DNA of human papillomavirus types 16 and 18: clinical trials conducted on 94 negative samples showed 100% specificity (interval 96.9% -100%, with a confidence level of 90%).

Analysis of similar samples by CE-marked reference kit confirms the results obtained in all cases.

• Instruction for use
• Molecular Diagnostic Products