RealLine VZV

Clinical information:

Primary VZV infection causes chicken-pox in children and serious complications of shingles include postherpetic  neuralgia,  zoster  multiplex,  myelitis,  herpes  ophthalmicus,  or  zoster  sine  herpete  in adults and rarely in children. In about 10 – 20 % of the cases, VZV reactivates later in life. It more commonly occurs in people over age 50, and in those who have a weakened immune system.

RealLine VZV (Str-format) assay kit is designed to detect varicella-zoster virus DNA isolated from clinical specimens using extraction kits:

RealLine DNA-Express (REF VBC8899)

RealLine DNA-Extraction 3 (REF VBC8889)

RealLine Extraction 100 (REF VBC8896)

RealLine VZV (Str-format) assay kit is intended for the detection of varicella-zoster virus DNA in clinical  specimens  (epithelial  cell  swabs  and  tissue fluid from  erosive-ulcerative  skin  lesions  and mucosa, urine, saliva, blood serum and plasma.) using the method of real-time 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 48 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 48 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 RealLine Cyclers (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.

For optimal results please always use the RealLine Internal Control. In case you do not use RealLine Extraction kits, order RealLine Internal Control (VBC8881) seperately.

CE IvD

RealLine DNA-Express (REF VBC8899)

RealLine DNA-Extraction 3 (REF VBC8889)

RealLine Extraction 100 (REF VBC8896)

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

Sensitivity

Sensitivity  control  was  performed  on  5  samples  containing  100  VZV  DNA  copies  per  sample, prepared  from  SRS  (Standard  Reference  Sample  containing  VZV  DNA).  The sensitivity  equals 100%.

Specificity

Specificity of VZV DNA detection was determined using Standard Reference Panel (SRP). Specificity of VZV DNA detection equals 100%.

Diagnostic sensitivity

Diagnostic sensitivity determination was performed on 50 positive samples. Sensitivity equals 100% (within the range 94 – 100 %, with a confidence level of 90 %).

Diagnostic specificity

Diagnostic specificity determination was performed on 50 negative samples. Specificity equals 100% (within the range 94 – 100 %, with a confidence level 90 %).

Analysis by the CE-marked reference kit showed full match of results.

• Instruction for use
• Molecular Diagnostic Products