Intended use
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.
Status
CE IvD
Validated extraction kits
RealLine DNA-Express (REF VBC8899)
RealLine DNA-Extraction 3 (REF VBC8889)
RealLine Extraction 100 (REF VBC8896)
Validated real-time PCR platforms
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).
Specifications
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.
Order information
Item number | Kit size | |
VBD2185 | 48 reactions | |
RealLine Internal Control | Kit size | |
VBC8881 | 250 reactions |