RealLine HPV HCR Screen

Clinical information:

Human Papilloma Viruses HPV are DNA-Viruses and in between are 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 %.

The RealLine HPV HCR Screen assay kit is designed for the detection of DNA of

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 manufacturer, it is necessary to use Internal Control sample (IC) (VBC8881, BIORON Diagnostics).

The assay is based on the real-time polymerase chain reaction (PCR) method with fluorescent detection of the amplified product. The results of PCR analysis are taken into account in complex diagnostics of disease.

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

Sensitivity

Sensitivity of detection of DNA HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (on four samples, containing 100 DNA copies, prepared from Standard Reference Samples) equals 100 %.

Specificity

Specificity of detection of DNA HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (using Standard Reference Panel of negative DNA-extracts) equals 100 %.

Diagnostic evaluation

Diagnostic sensitivity

Diagnostic sensitivity of DNA detection of human papilloma virus of high cancer risk: clinical trials, conducted on 95 positive samples showed a 100 % sensitivity (range 97% -100%, with 90% confidence level).

Diagnostic specificity

Diagnostic specificity of DNA detection of human papilloma virus of high cancer risk: clinical trials, conducted on 54 negative samples showed a 100 % specificity (range 95 % -100 %, with 90 % confidence level).

• Instruction for use
• Molecular Diagnostic Products