TREPONEMA PALLIDUM

PlexPCR® VHS

Detect and differentiate common lesion-causing pathogens

Herpes simplex virus (HSV-1&-2), Varicella zoster virus (VZV) & Treponema pallidum (Syphilis) in a single-well multiplex qPCR test

 

Simplify lesion diagnostics

Why use PlexPCR® VHS?

Syphilis rates are increasing around the globe and symptomatic or visual lesion diagnostic approaches may be missing some cases presenting as an atypical lesion. Molecular diagnostics are recommended for management of genital lesions to improve diagnostic accuracy and subsequent patient management.

  • Ulcerations or lesions in the ano-genital and oral regions can be caused by a variety of bacterial and viral infectious agents.
  • Syphilis lesions can present atypically, be painful, and appear indistinguishable from herpes.
  • Up to 3% of genital lesions may be atypical zoster (VZV) presentations.

Validated on hundreds of clinical samples, PlexPCR® VHS demonstrates excellent sensitivity and specificity.

SpeeDx PlexPCR VHS product box
Scientist using thermocycler

PlexPCR® VHS workflow solution

Streamline your workflow and increase productivity for rapid, routine diagnostics. Full automation options include sample and qPCR set-up, through to validated software solutions for automated result calling and simple data processing.

 

SpeeDx analysis software is included in contract pricing, is license free, and installed on a high security and GDPR compliant platform. Designed to support the IVD laboratory environment, features include:

  • audit trails
  • user traceability
  • LIS connectivity
  • QA and batch management

PlexPCR® VHS Performance Specifications

Demonstrated clinical performance – for more detail please see the PlexPCR® VHS Instructions for Use.

Performance of PlexPCR® VHS
HSV-1 HSV-2 VZV T.pallidum
Sensitivity 97.7% 100% 100% 100%
Specificity 99.7% 99.7% 99.7% 100%

Specifications

The PlexPCR® VHS kit is a qualitative real-time PCR (qPCR) assay for the detection of Herpes simplex virus 1 (HSV-1), Herpes simplex virus 2 (HSV-2), Varicella zoster virus (VZV) and Treponema pallidum.

Targets

Single well: Herpes simplex virus 1 (HSV-1), Herpes simplex virus 2 (HSV-2), Varicella zoster virus (VZV), Treponema pallidum (Syphilis) & Internal Control

 

Sample types

  • Swabs: genital, non-genital, anal/rectal and oral

 

Amplification instruments

  • Applied Biosystems® 7500 Fast (7500 Fast)
  • Roche LightCycler® 480 Instrument II (LC480 II)
  • Bio-Rad CFX96 IVD (CFX96 IVD)
  • Bio-Rad CFX96 CFX96 Touch (CFX96 Touch)

Shipping Conditions

Products are shipped on dry ice or ice gel packs.

 

Storage & stability

Expiry dates are stated on the labels. It is recommended that freeze/thaw cycles be limited to less than 15. Store protected from light at – 20°C.

 

Intended use

For in vitro diagnostic use. Not for sale in the USA.

 

Regulatory status

CE-IVD, TGA cleared

Resources

Please contact your local representative if you can’t find what you are looking for.

Safety Data Sheets

 

Current Software Version

  • PlexPCR® VHS (7500) v3.1
  • PlexPCR® VHS (LC480) v2.1
  • PlexPCR® VHS (CFX) v2.1
  • PlexPCR® HV (7500) v2.1
  • PlexPCR® HV (LC480) v2.1
  • PlexPCR® HV (CFX) v2.1

 

Related Products

Certificate of Analysis

For information contact tech@speedx.com.au

 

Instructions for use

For information contact tech@speedx.com.au

 

Software Download

For information contact tech@speedx.com.au

Publications & Media

We are committed to supporting continued scientific discovery and generation of clinically relevant data. Collaborations with key researchers and clinicians around the globe help us improve diagnostics and address urgent clinical needs.

BMJ journal

Evaluation of PlexPCR® VHS for diagnosis of genital lesions

Tan et al. STI & HIV World Congress (Joint Meeting of the 23rd ISSTDR and 20th IUSTI), July 14–17, 2019, Vancouver, Canada.

Used PlexPCR® VHS to test 211 samples consisting of genital, anal/rectal, oral and non-genital swabs. Sensitivity/specificity of each target compared to in-house qPCR was 100%/99.4% for HSV-1, 96.0%/98.8% for HSV-2, 100%/100% for VZV and 100.0%/100.0% for TP.

SPEEDX PLEXPCR VHS EVALUATION

SPEEDX PLEXPCR™ VHS EVALUATION

Vipond B et al. 31st Congress of IUSTI-Europe on Sexually Transmitted Infections, Aug 31 – Sept 2, 2017, Helsinki, Finland.

Used PlexPCR® VHS to test 373 genital and non -genital swab samples compared to in-house method. Prevalence for each target: HSV-1 24%, HSV-2 21.3%, Syphilis 1.7% VZV 0.3%. Sensitivity and specificity of 96-100% across targets.

Validation of PlexPCR® VHS Assay – Symposium Presentation

Validation of PlexPCR® VHS Assay – Symposium Presentation

Goldstein et al. SpeeDx Satellite Symposium (ECCMID) April 14, 2019, Amsterdam, Netherlands. 

Discusses rising rates of Syphilis and the importance of including molecular tests when diagnosing symptomatic lesions. Assesses PlexPCR® VHS test for lesion diagnostics and identifies positive syphilis samples that would otherwise not have been screened using serology.

Ordering Information

Please contact SpeeDx for information about offering SpeeDx diagnostics in your clinic or for a list of current pathology clinics where SpeeDx testing is available.

Product Compatible Size Catalogue
PlexPCR® VHS* LC480 II 100 reactions 1121001
ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx҂ 100 reactions 1123001
CFX96 IVD/CFX96 Touch# 100 reactions 1125001
PlexPCR® VHS Analysis Software* LC480 II 1 Unit 99005
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx
1 Unit 99004
CFX96 IVD/CFX96 Touch# 1 Unit 99006
PlexPCR® HV Analysis Software* LC480 II 1 Unit 99013
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx
1 Unit 99007
CFX96 IVD/CFX96 Touch# 1 Unit 99014
PlexPCR® Colour Compensation*^ kit LC480 II 2 reactions 90001

*Not for sale in USA
҂Validated on the ABI 7500 Fast Instrument
Validated on LightCycler 480 II
#Validated on CFX96 IVD
^Supplied upon request. This kit is only required for initial set-up to establish calibration of PlexPCR® and ResistancePlus® kits on the LC480 instrument, see instruction for use for details.

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