RealLine HPV HCR Genotype

Clinical information:

Human Papilloma Viruses HPV are DNA-Viruses and in between 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-carcinogenic-risk types HPV”. High-carcinogenic-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 Genotype assay kit is intended for differential determination of DNA of high carcinogenic cancer human papillomavirus (HPV) types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 isolated from clinical specimens using the validated 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 is necessary to use Internal Control sample (IC) (VBC8881, BIORON Diagnostics).

RealLine HPV HCR Genotype assay kit is intended for the differential detection of high-risk human papillomavirus (HR HPV) types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59 DNA in clinical specimens (cervical swabs) using real-time polymerase chain reaction (PCR) with fluorescence detection.

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

The Str-Format Kit contains 4 x 96 tubes (0.2 ml each) in strips with lyophilized Mastermix. For the test 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 a Positive Control sample.

For each clinical specimen there is a differential detection of the described high carcinogenic risk viruses (paragraph.3).

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

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 RealLine Cycler (BIORON Diagnostics GmbH), iQ™ iCycler, CFX™96 (Bio-Rad, USA) and DT-96 (DNA-Technology, Russia).

Sensitivity

Sensitivity of detection 100 copies of DNA of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 of high cancer risk the standard reference samples equals 100%.

Specificity

Specificity of detection DNA of HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 of high cancer risk (on samples, not containing DNA of given types of HPV, but containing DNA of HPV of 8 other types) on equals 100 %.

Diagnostic evaluation was performed on the following clinical samples:

10 clinical samples obtained from healthy donors.

5 clinical samples obtained from patients with STD symptoms but without laboratory signs of the papillomavirus infection.

5 clinical samples containing human papillomavirus types 6 and 11.

44 clinical samples obtained from patients with diagnosed types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 of HPV HCR.

All samples were analyzed in “RealLine HPV HCR genotype” assay kit and the CE-marked reference kit. The obtained results have shown total coincidence between the “RealLine HPV HCR genotype” assay kit and the CE-marked reference kit – 100 % sensitivity and specificity according to the reference kit.

• Instruction for use
• Molecular Diagnostic Products