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  • Real-time
    PCR
  • CE-IVD
    marked

Allplex™
Vaginitis Screening Assay

Convenient and accurate diagnostic solution to identify major pathogens related vaginitis using real-time PCR

Allplex™ Vaginitis Screening Assay is a multiplex real-time PCR assay that detects and identifies major pathogens related vaginitis simultaneously. Based on Seegene’s proprietary MuDT™ Technology, this assay reports multiple Ct value of each pathogen in a single channel. And it provides automated interpretation of BV using Seegene Viewer based on quantification information of major targets

Key Features and Benefits

  • Automatic BV interpretation

    Automatic BV interpretation as Normal, Intermediate and bacterial vaginosis

  • Quantitative information

    Providing quantitative information for 3 major bacteria associated with vaginosis

  • Multiplex real-time PCR

    Simultaneous detection of major pathogens causing vaginitis

  • User-friendly workflow

    Convenient workflow using Seegene’s automated one platform

  • Proper patient care

    Accurate test results allow to quick and proper treatment

  • Multi-Ct in a single channel

    Individual Ct value of multiple analytes in a single channel of real-time PCR instrument (MuDT™ Technology)

  • Automatic data analyzer

    Automated data interpretation and LIS interlocking with Seegene Viewer

  • Proper patient care

    Quick and proper treatment provided by accurate test results

  • UDG system

    Utilization of the UDG system to prevent carry-over contamination

  • Informative assay

    Assistant of appropriate treatment and management for co-infection

  • Whole process validation

    Whole process validation from extraction to PCR by whole process control

  • Analytes

    Allplex™
    Vaginitis Screening Assay

    • Atopobium vaginae (Quantitative) (AV)
    • Candida albicans (CA)
    • Candida others[1] (CO)
    • Gardnerella vaginalis (Quantitative) (GV)
    • Lactobacillus spp.[2] (Quantitative) (Lacto)
    • Mobiluncus spp.[3] (Mob)
    • Trichomonas vaginalis (TV)
    • Internal Control (IC)

  • Specimens

    • Genital swab
    • Liquid based cytology (e.g., ThinPrep® and Surepath™)

  • Ordering Information

    Product
    Cat No. / Size
    Allplex™ Vaginitis Screening Assay
    SD10321Z / 25 rxns
    SD9750X / 100 rxns

Result

Multiple Ct value in a single channel

* Qt: Quantitative Threshold(log)

The result represents the co-infection of CA, Lacto and Mob in FAM (Ct values 25.49(CA) and 102.05 copies/rxn(Lacto)) and Quasar 670 channel (Ct values 35.05), respectively. And this assay provides interpretation of Bacterial Vaginosis (BV) by quantitative analysis of major bacteria related vaginosis.

Publication

- Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross-sectional study

- International Society for the Study of Vulvovaginal Disease Recommendations for the Diagnosis and Treatment of Vaginitis

Note

[1] C. krusei, C. glabrata, C. dublinensis, C. parapsilosis, C tropicalis, C. lusitaniae

[2] Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus jensenii

[3] Mobiluncus mulieris, Mobiluncus curtisii