RealLine HPV 6 / 11

Clinical information:

Human Papilloma Viruses HPV are DNA-Viruses, and more than 100 different types are known at that moment. While the majority of HPVs cause no symptoms, some can cause low severe symptoms like warts and a few types are known to cause cancer. HPV types that are more likely to lead to the development of cancer are referred as High-Carcinogenic-Risk types HPV. The HPV Types 6 and 11 are known as Low-Carcinogenic-Risk-Types and cause genital warts.

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 6/11 (Str-format) assay kit is intended for the differential detection of human papillomavirus (HPV) types 6 and 11 DNA in clinical specimens (cervical swabs) using real-time polymerase chain reaction (PCR) with fluorescence detection.

The assay is based on real-time polymerase chain reaction (PCR) method with fluorescent detection of amplified product.

The Str-Format Kit contains 96 tubes (0.2 ml) in strips with lyophilized master mix. 50 μl of extracted DNA have to be pipetted into the tube and the ready master mix 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. The kit is compatible with real-time PCR systems such as 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. The kit is compatible with real-time PCR systems such as iQ™ iCycler, CFX™96 (Bio-Rad, USA), DT-96 (DNA-Technology, Russia) and RealLine Cycler (BIORON Diagnostics GmbH).

Sensitivity

Sensitivity control was performed on 5 samples containing 100 DNA copies per sample types HPV 6 and 11, prepared from Standard Reference Samples containing DNA of HPV types 6 and 11, (HPV 6 DNA SRS; HPV 11 DNA SRS).

The sensitivity equals 100 %.

Specificity

Specificity of HPV 6 and 11 DNA detection was determined using 5 negative DNA-extracts samples not containing DNA of STD agents or herpes virus infections, including HPV types 6 and 11 DNA, and containing IC DNA.

Specificity of HPV 6/11 DNA detection equals 100 %.

Diagnostic evaluation

Diagnostic evaluation was performed on 50 clinical samples:

10 clinical samples obtained from healthy donors;

8 clinical samples obtained from patients with STD symptoms;

3 clinical samples obtained from patients with diagnosed type of HPV 16, 18, 35;

18 clinical samples obtained from patients with cytological signs of HPV infection.

All samples were analyzed with the RealLine HPV 6 / 11 assay kit (BIORON Diagnostics) and the CE-marked reference kit.

Results obtained show total coincidence between the RealLine DNA HPV 6/11 assay kit and the CE-marked reference kit – 100 % sensitivity and specificity according to the reference kit.

• Instruction for use
• Molecular Diagnostic Products