MTB/MDR/XDRe Detection

CE-IVDD

Allplex™ MTB/MDR/XDRe Detection is a qualitative real-time PCR in vitro diagnostic test for single or multiple detection of Mycobacterium tuberculosis (MTB) and its resistance to first-line anti-tuberculosis drugs (Isoniazid and Rifampicin) and second-line anti-tuberculosis drugs (Fluoroquinolones and Injectable drugs) in sputum, culture, and bronchial washing specimens, obtained from individuals exhibiting signs and/or symptoms of a Mycobacterium tuberculosis infection. The test is intended for use as an aid in the diagnosis Mycobacterium tuberculosis infection if used in conjunction with other clinical and epidemiological information.

Tuberculosis

Key Features

Multiplex real-time PCR
- Simultaneous detection of Mycobacterium tuberculosis and 38 mutations associated with drug-resistance TB
Prediction of antibiotic resistance
- Detection and identification of mutations associated antibiotic resistance for appropriate infection control
User-friendly workflow
- Convenient workflow using Seegene’s automated one platform
DNA extraction solution
- Reagent for DNA Detection is provided, purchase of DNA extraction kit is unnecessary

Specification

Analytes

- Mycobacterium tuberculosis
- Rifampicin-resistance (18 mutations)
- Isoniazid-resistance (7 mutations)
- Fluoroquinolone-resistance (7 mutations)
- Injectable drug-resistance (6 mutations)
- Internal Control (IC)

Specimens

- Sputum
- Bronchial washing
- Cultured cell
  (Solid, Liquid)

Compatible Instrumentation (CE-IVD Marked)

Real-time PCR
- CFX96™ Real-time PCR Detection System
- CFX96™ DX System
Automated Extraction
- SEEPREP32™
- Maelstrom™ 9600
Automated Extraction & PCR Setup
- Seegene STARlet
- Seegene STARlet-AIOS™
- Seegene STARlet 96MPH
- Seegene NIMBUS