Vaginitis Screening Assay

CE-IVDD

Allplex™ Vaginitis Screening Assay is a qualitative and quantitative real-time PCR in vitro diagnostic test for single or multiple detection of diagnosis of seven pathogens causing 3 major vaginitis; Bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.

Reproductive Tract Infections

Key Features

High multiplex detection
- Detects and identifies 7 causative pathogens of vaginitis simultaneously with a single test
Comprehensive information for Vaginitis
- Automatically interprets the status of bacterial vaginosis (normal, intermediate, or bacterial vaginosis)
- Provides quantitative results for 3 vaginitis pathogens (A. vaginae, Lactobacillus spp., G. vaginalis)
Fully automated workflow
- Provides a fully automated workflow using Seegene STARlet-AIOS™

Specification

Analytes

- Atopobium vaginae (Quantitative)
- Candida albicans
- Candida others
- Gardnerella vaginalis (Quantitative)
- Lactobacillus spp. (Quantitative) (Lacto)
- Mobiluncus spp.
- Trichomonas vaginalis
- Internal Control (IC)

Specimens

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

Compatible Instrumentation (CE-IVD Marked)

Real-time PCR
- CFX96™ Real-time PCR Detection System
- CFX96™ DX System
- CFX Opus 96 Dx
Automated Extraction & PCR Setup
- Seegene STARlet
- Seegene STARlet-AIOS™
- Seegene NIMBUS