NG-TEST^® Candida auris

Rapid Detection Made Simple

NG-TEST® Candida auris is a rapid lateral flow immunoassay for the detection of Candida auris from pure yeast colonies grown on agar plates.

Overview

This easy-to-use assay provides results in 15 minutes and does not require complex instrumentation. It offers laboratories a simple phenotypic method for detecting C. auris as part of research, method development, and validation workflows.

NG-TEST® Candida auris is the first commercialized lateral flow assay for Candida auris and has received FDA Breakthrough Device designation. The product is currently available as Research Use Only (RUO).

Key Features:

15-minute results from colony
No specialized instrumentation required
Simple workflow
Phenotypic detection
20-test kit format
RUO* for research workflows, method development, and validation studies

*For Research Use Only.
Not for use in clinical diagnostic procedures

Why Choose NG-TEST^®?

Results in 15 Minutes

Dramatically reduce turnaround time-to-result from culture.

Phenotypic Accuracy

Provides rapid detection of C. auris from colonies grown on agar plates. Sources: IFU, Frontiers in Microbiology
Published literature notes that C. auris can be misidentified by traditional phenotypic and biochemical methods. Source: CDC

Minimal Lab Footprint

A simple, low-tech solution that requires no expensive capital equipment or specialized extensive training.

Rapid results

NG-TEST® Candida auris delivers results in approximately 15 minutes from isolated colonies, helping laboratories obtain answers faster than many conventional detection workflows.

Simple workflow

The test is designed for straightforward use with minimal equipment, making it easy to integrate into laboratory workflows without the need for high-end molecular systems or specialized instrumentation.

Phenotypic detection

Unlike molecular methods that detect genetic material, NG-TEST® Candida auris is a phenotypic assay that detects C. auris from fresh colonies.

Cost-conscious alternative

The assay does not require major capital equipment and may offer a practical option for laboratories seeking to simplify their workflow.

Supports research and validation efforts

As an RUO product, NG-TEST® Candida auris may be used to support:

Method development
Internal evaluations
Validation studies
Research applications involving C. auris colony detection

Why it Matters

NG-TEST^® Candida auris offers a simple, rapid option for colony-based detection without the instrumentation requirements of PCR or MALDI-TOF systems.

Fast, Simple, and Accurate Workflow*

Sample Collection

Select a pure yeast colony directly from an agar plate, such as HardyCHROM™ Candida+auris (Cat. no. G343)

Preparation

Mix the colony with the provided lysis and migration buffers in microtubes.

Inoculation

Dispense the prepared sample onto the NG-TEST^® lateral flow cassette.

Rapid Read

Interpret the results visually after only 15 minutes.

*See IFU for complete instructions.

Kit Contents & Specifications

Catalog No. NGBCA
20-test kit

Kit Contents

Each kit contains:

20 test cassettes
Lysis buffer
Migration buffer
20 Microtubes (2mL)
Instructions for Use
Quick reference instructions

The kit is designed to provide the materials needed for colony-based testing in a convenient, ready-to-use format.

Specifications

Product name: NG-TEST® Candida auris
Catalog number: NGBCA
Format: Lateral flow immunoassay
Sample type: Pure yeast colonies grown on agar plates
Time to result: Approximately 15 minutes
Kit size: 20 tests
Status: Research Use Only (RUO)

Intended use note
This product is labeled for Research Use Only and is not for use in diagnostic procedures.

Technical FAQ

Addressing technical barriers and regulatory nuances to ensure that laboratory staff are empowered with the accurate information necessary for high-stakes research environments.

What sample type is used with NG-TEST® Candida auris?

NG-TEST® Candida auris is used with pure yeast colonies grown on agar plates. The assay is intended for colony-based workflows rather than direct specimen testing.

What is the turnaround time for the assay?

15 minutes from the time-to-result from culture.

Where does this test fit in the laboratory workflow?

NG-TEST® Candida auris fits into the workflow after colony growth. Once a pure colony is available, the assay can be used as a rapid phenotypic method for detection in research, evaluation, and validation workflows.

Does the assay require specialized instrumentation?

No. The test is a lateral flow immunoassay and does not require molecular instrumentation, MALDI-TOF, or large automated identification systems.

How does this differ from molecular methods such as PCR?

NG-TEST® Candida auris offers a simpler colony-based workflow that does not require high-end instrumentation. It may be useful in settings where laboratories want a rapid, easy-to-perform method for detecting Candida auris from colony.

How does this compare with MALDI-TOF or other automated identification systems?

Genotypic tests (PCR) detect genetic material, which may originate from non-viable organisms, potentially leading to irrelevant positives. The NG-TEST® is a phenotypic test that detects expressed antigens, ensuring the detection of active, viable organisms from a colony.