Intended use
Clinical information:
HSV-1 (Human Herpes Simplex Type 1) is an oral form of herpes, which typically affects the mouth and surrounding areas on the face. In addition HSV-1 can cause encephalitis, keratoconjunctivitis, stomatitis and skin infections. Transmission generally occurs through saliva and rarely through sex contact.
HSV-2 (Human Herpes Simplex Type 2) causes most cases of genital herpes as well as the neurological manifestations such as meningitis and radiculitis. Pregnant women and infants are risk groups for HSV infections, since when infants do contract neonatal herpes, they may suffer serious neurological damage, mental retardation or death. In addition HSV-2 is known to increase a person’s risk of contracting HIV.
RealLine HSV-1/HSV-2 (Str-format) assay kit is designed for detection of DNA and differential determination of herpes simplex virus types 1 and 2 isolated from clinical specimens using extraction kits
RealLine DNA-Express (REF VBC8899)
RealLine DNA-Extraction 2 (REF VBC8897)
RealLine DNA-Extraction 3 (REF VBC8889)
RealLine Extraction 100 (REF VBC8896)
As automated method for specimen purification the INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany) and INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany) are validated.
RealLine HSV-1/HSV-2 (Str-format) kit is is intended for differential detection of DNA of Herpes Simplex virus types 1 and 2 in clinical specimens (swabs of epithelial cells, tissue fluid, erosive-ulcerative skin lesion, mucosa, cerebrospinal fluid, saliva semen, prostate fluid, urine, serum, plasma, bronchoalveolar lavage) using the method of real-time polymerase chain reaction (PCR) with fluorescence detection of amplified product.
The Str-Format Kit contains 96 tubes (0.2ml) 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 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). RealLine Cycler (BIORON Diagnostics GmbH) 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 2 (REF VBC8897)
RealLine DNA-Extraction 3 (REF VBC8889)
RealLine Extraction 100 (REF VBC8896)
INSTANT Virus RNA/DNA Kit – IPC16 (Roboscreen GmbH, Germany) – automated
INSTANT Virus RNA/DNA Kit – FX (Roboscreen GmbH, Germany) - automated
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 iQ™ iCycler, CFX™96 (Bio-Rad, USA), RealLine Cycler (BIORON Diagnostics GmbH) and DT-96 (DNA-Technology, Russia).
Specifications
Specificity of HSV-1/HSV-2 DNA detection was determined using the Standard Reference Panel of negative DNA-extracts, consisting of samples containing IC DNA and not containing DNA of STD agents. Specificity of HSV-1/HSV-2 DNA detection equals 100%.
Sensitivity control was performed on 5 samples containing 100 HSV-1/HSV-2 DNA copies per sample, prepared from Standard Reference Samples containing DNA of HSV 1 and 2 types, (HSV-1/HSV-2 DNA SRS. The sensitivity equals 100%.
Diagnostic evaluation was performed on 50 clinical samples:
20 samples, negative samples; 20 samples, obtained from HSV-1/HSV-2 infected individuals; 10 samples, obtained from individuals infected with other types of HSV.
Determination of sensitivity was performed on 20 clinical samples obtained from the clinical material containing HSV types 1 and 2 with the CE-marked reference kit. RealLine HSV-1 / HSV-2 kit determined all 20 samples as positive. Analysis by the reference kit proved all 20 samples containing HSV-1/HSV-2 to be positive. Diagnostic sensitivity equals 100%.
Determination of specificity was performed on 30 samples obtained from donors and individuals infected with other types of HSV, with the CE-marked reference kit. When studying clinical samples obtained from healthy donors RealLine HSV-1 / HSV-2, negative results were recorded for all 20 samples. When studying clinical samples obtained from individuals infected by other types of HSVs using RealLine HSV-1 / HSV-2 negative results were recorded for all 10 samples. Specificity equals 100%.
Analysis by the CE-marked reference kit showed full match of results.
Order information
| Item number | Kit size | |
| VBD2195 | 96 reactions | |
| RealLine Internal Control | Kit size | |
| VBC8881 | 250 reactions |