Mentype® MycoDermQS Lateral Flow

Multiplex PCR Diagnostics in Combination with Lateral Flow DNA Detection

Product Information
Mentype® MycoDermQS Lateral Flow is a molecular detection system for the highly effective diagnosis of dermatomycosis in the medical routine laboratory, based on the use of native samples from skin, nails or hair roots. The diagnostic system consists in the combination of three modules, according on the requirements. These three Multiplex-PCR-panels display the most common pathogens found within this indication in Europe. After PCR-amplification the DNA detection is carried out by the use of Lateral Flow stripes, one of the most specific pathogenic-DNA nowadays.

Product name   Reactions   Order Number
MycoDermQS Lateral Flow PCR 1   10   45-17611-0010
MycoDermQS Lateral Flow PCR 1   50   45-17611-0050
MycoDermQS Lateral Flow PCR 2 Kit (50)   50   45-17612-0050
MycoDermQS Lateral Flow PCR 3 Kit (50)   50   45-17613-0050
MycoDermQS Lateral Flow PCR 2+3   25+25   45-17615-0050

 

Application Information

The Modular Design of Mentype® MycoDermQS Lateral Flow

1. Perfomance of the Multiplex PCR
The application of the three Mentype® MycoDermQS Lateral Flow modules allow the increase of diagnostic depth as required. The herein submitted pathogen-combinations correspond to the issues from the medical practice all over Europe
.

Modul PCR 1
is designed for the detection of dermatophytes and yeasts in general.
In addition, the mold Scopulariopsis brevicaulis and the dermatophyte Trichophyton rubrum are detected at their species level.

Modul PCR 2
allows detection of the following dermatophytes: T. interdigitale / A. vanbreuseghemii; T. mentagrophytes, T. tonsurans, T. violaceum, A. benhamiae/ T. erinacei and T.verrucosum.


Modul PCR 3
is required to detect  the Microspores M. audouinii, M. gypseum, M. canis, as well as Epidermophyte E. floccosum on species level.

The Internal Quality Control: The Quality Sensor (QS)
In all three modules the Rili-BÄK and MiQ guidelines compliant Extraction Control is used.
This means, that an inherit positive control shows the success of the extraction and the amplification. The quality control band is seen on every test stripe, except negative control.


2. Detection of pathogen DNA on Lateral Flow Test Strips
After completion of the multiplex PCR, the specific DNA amplification products are incubated with the appropriate probe mix and hybridized. The running buffer-hybridisation mixture is - after binding to the lateral flow test strips - responsible for the specific pathogen bands. The evaluation of the results is possible visual or by appropriate technical readers.

3. Overview of the Modular Design and Types of Pathogens

MycoDermQS Lateral Flow PCR 1

Dermatophytes / Yeasts / Mould

QS*

T. rubrum   

  

Dermatophyton spp. (TME)

Scopulariopsis brevicaulis 

Candida

 spp.    

C. albicans

C. tropicalis

C. glabrata

C. guilliermondii (Meyerozyma guilliermondii)

C. krusei (Pichia kudriavzevii, Issatchenkia orientalis)

C. parapsilosis

*QS = DNA extraction and PCR amplification control according to Rili-BÄK and MiQ



MycoDermQS Lateral Flow PCR 2

Trichophyton spp.

QS*

T. interdigitale

  A. vanbreuseghemii, T. mentagrophytes

  T. tonsurans

  T. violaceum

  A. benhamiae/ T. erinacei + T. verrucosum

*QS = DNA extraction and PCR amplification control according to Rili-BÄK and MiQ



MycoDermQS Lateral Flow PCR 3

Microsporum spp./ Epidermophyton

QS*

M. audouinii

M. gypseum

M. canis

Epidermophyton floccosum

*QS = DNA extraction and PCR amplification control according to Rili-BÄK and MiQ

 

Test performance – a brief overview

I Sample preparation
In contrast to classical fungal diagnosis, this molecular genetic kit also detects dead pathogenic material. Samples can be obtained even during an ongoing therapy. Skin scales, hair stumps and nails are suitable as sample materials. Systems based on silica membranes should be used for subsequent isolation and purification of the DNA.

II PCR amplification (modulebased system)
A)  Analysis within two steps:
1.    PCR 1
2.    PCR 2 and/or PCR 3

B)  Anaylsis in one step:
PCR 1, PCR 2 and PCR 3 simultaneously

The minimal detection limit of the molecular differential diagnosis is up to 10 pg pathogenic DNA. Mentype® MycoDermQS Lateral Flow also includes the Quality Sensor (QS), an internal DNA extraction and amplification control used for quality assurance purposes. The QS indicates, whether the PCR was carried out successfully. In addition, a positive and negative control should always be carried out for validated results.

III  Lateral Flow

Lateral flow assay stripes are used for detection. The reference stripe depicted in the picture below shows exemplarily all detectable pathogenic amplificates for each PCR reaction and the QS control.

Automatic Evaluation of the Test Stripes
The MycoDermQS Lateral Flow system is suitable for an automatic evaluation of the test stripes with an appropriate reader. For further information on readers, please contact Biotype Diagnostic GmbH.

3. Quality Features / Regulatory Compliance

Mentype® MycoDermQS Lateral Flow meets the requirements of Rili-BÄK, MiQ and all other possible quality systems by using the quality sensor for extraction control and sequence-specific probes in hybridization. This makes the success of any single investigation documentable and traceable.

Extensive validations, including a clinical performance evaluation were made. The Mentype® MycoDermQS Lateral Flow test system has been authorized as an In-Vitro Diagnostic Medical Device according to 98/79 / EC (CE - IVD) since 10.06.2015.

Mentype® MycoDermQS Lateral Flow is designed for use by qualified personnel (e.g. laboratory technicians and physicians) who are trained in molecular biological techniques.

*Rili-BÄK (Guideline of the German Medical Association) The new Guideline of the German Medical Association (Bundesärztekammer / Rili-BÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) specifies the basic principles of internal and external quality assurance of all laboratory medical analyses including those in virus diagnostics (please see: Deutsches Ärzteblatt, Jg. 108, Heft 30, 29.07.2011, Seite A 1647-1651).
**MiQ (Microbiology procedure quality standards), DGHM, German Society for Hygiene and Microbiology.

MycoTYPE® Skin - the Possibility to use the Mentype® MycoDermQS Lateral Flow System Without Having a Corresponding Laboratory

If it is not possible for you to find a lab that offers the Mentype® MycoDermQS examination, the MycoTYPE® Skin application for medical practices could be interesting for you.

The MycoTYPE® Skin application includes the sample examination by a contract laboratory in Germany and the information about the results by email.

Therefore you will have to order your individual examination number by email and send the sample to our lab in Germany. The payment will be carried out in advance by PayPal.

Your advantages:

-    you are able to offer the examination without needing the equipment by yourself
-    payment by PayPal is safe and easy
-    23 pathogens are examined simultaneously
-    98 % of all Europe's dermatomycoses pathogens are recognized
-    up to 50 % higher detection rate in contrast to conventional methods
-    a very small amount of sample is sufficient
-    samples of already medicated or treated patients are immediately usable
-    mixed infections are reliably detected
-    the laboratory investigation is completed within 24 hours
-    the examination at the DNA level is the most specific way of pathogen detection nowadays
.

For more information and enquiries about Mentype® MycoDermQS Lateral Flow please contact us: www.biotype.de. Tel.: +49 351 8838 444 (Mo to Fr, 9 am to 5 pm)
E-Mail: info@biotype.de

Your contact
Dr. Anja Seiler
Tel.: +49 (0) 351 8838 411
Fax: +49 (0) 351 8838 403
support@mycoderm.de