Multiplex Diagnostics

created on

Multiplex Diagnostics


Multiplex diagnostics panels

 

HIGH MULTIPLEXING CAPACITY – multiplex tandem PCR (MT-PCR) panels utilize the patented Tandem-Plex® technology to provide unmatched multiplexing capability, allowing comprehensive testing of over 30 genetic markers from a single sample.

HIGH SENSITIVITY – The Tandem-Plex® technology allows for amplification of a small concentration of nucleic acids, even in the presence of other highly abundant genetic material. Each reaction occurs independently, thus preserving the relative quantity between analytes.
 

HIGH SPECIFICITY – Nested primers ensure that only the relevant nucleic acids are amplified for detection. Each target is amplified independently which eliminates competition between targets, enabling the highest levels of specificity. With MT-PCR, you can be confident in the reliability of results to help you make the appropriate diagnosis.

 

 

 

In doubt of which panel to choose?

The Panel Selector will help you selecting the panel(s) that suit(s) your targets of interest, format and application.

 

BioNordika offers a free of charge excel file with calculation of cost per target and cost per patient sample. Feel free to contact us for more information!

 

Multiplex Tandem PCR Systems

AusDiagnostics offers medium and high-throughput systems with a wide range of CE-IVD panels for molecular diagnostics of human pathogens based on the MT-PCR technology. MT-PCR is a unique patented technology that allows the detection of multiple targets in one sample without compromising analytical sensitivity and specificity.

 

High-Plex 24

Medium throughput – 24 samples per run
 

  • Up to 24 samples in 3 hrs 10 mins.
     
  • Small footprint to save precious bench space.
     
  • Minimal hands-on time – just 11 mins.
     
  • Detect up to 30 pathogens and genetic markers simultaneously in up to 24 samples per run.
     
  • Comprehensive range of multiplex panels.
     
  • Cost effective from just 5 samples per run.
     
  • Automatic results calling – results automatically analysed

 

 

 

 

 

 

 

 

 

Ultraplex 3

High throughput – 96 samples per run

 

  • Up to 96 samples in 3 hrs.

  • Set up in as little as 3 mins.

  • Less than 10 mins hands-on time

  • 8-channel pipetting for faster processing- eliminating the need for maintenance system liquids and associated maintenance operations.

  • Detect 30 pathogens and genetic markers simultaneously in up to 96 samples per run.

 

 

Urinogenital infections & resistance MT-PCR panel

How to use this panel as a secondary screening?

AusDiagnostics offers a universal MT-PCR panel, Urinogenital and Resistance 12-well (Ref 87123), that can be used on both High-Plex 24 and Ultraplex 3. This panel detects 7 major STIs and identifies the presence of resistant M.genitalium and N.gonorrhoeae.

 

Urinogenital and Resistance 12-well (87123)

Major STI 

  • Chlamydia trachomatis
  • Chlamydia trachomatis LGV
  • Neisseria gonorrhoeae (2 targets)
  • Trichomonas vaginalis
  • Mycoplasma genitalium

 

Conditionally pathogenic flora 

  • Ureaplasma urealyticum
  • Ureaplasma parvum
  • Mycoplasma hominis

Resistance markers 

  • M.genitalium macrolide resistance
  • M.genitalium fluoroquinolone resistance
  • N.gonorrhoeae ceftriaxone resistance

 

Non-specific urethritis
If you get a negative result for chlamydia or gonorrhoea from your primary screening you can use this test as a downstream test to screen for M.genitalium + resistence, urealplasma urealyticum, trichomonas vaginalis. It can be worth looking at our panel for bacterial vaginosis as well (Ref 87124).
 

Positive M.genitalium or gonorrhoea
If you get a positive test from your primary screening, this panel offers you a confirmation test as well as test- ing the M.genitalium resistence (fluoroquinolone and macrolide) + N. Gonorrhoeae (ceftriaxone resistance)
 

Positive rectal chlamydia (MSM)
Lymphogranuloma venerum (LGV) is an infection caused by Chlamydia serotype L. If your primary screening shows a positive chlamydia on rectal samples, the sample can be further tested.
 

M.hominis and U. Parvum
M. hominis and Ureaplasma belong to human genitourinary microbiota. Hence, some clinical microbiologists believe that these are irrelevant to detect. However, both species can cause urogenital infections and accelerated newborn delivery in pregnant women. Therefore, studies recommend performing screening tests in pregnant women before the delivery in order to prevent transmission to neonates and consequent infections and morbidities among them. (Sobouti, Behnam et al. “Colonization of Mycoplasma hominis and Ureaplasma urealyticum in pregnant women and their transmission to offspring.” Iranian journal of microbiology vol. 6,4 (2014): 219-24.)
 

Positive Trichomonas vaginalis from culturing
If you are culturing your TV and you get a positive result, it might be worth re-testing and also checking for the other possible pathogens. TV increases chances to get infected by other STIs.
 

Macrolide and fluoroquinolone resistance in Mycoplasma genitalium
This assay is designed to amplify wild-type sequences (23S gene for macrolide resistance, or parC gene for fluoroquinolone resistance). Strains containing resistance-associated mutations in these regions (A2058 or A2059 for 23S, S83 or D87 for parC) will be amplified with lower efficiency. Comparison of the concentrations calculated by the MT-PCR Results software for each of these targets with a marker elsewhere in the Mycoplasma genitalium genome allows the specific identification of mutant strains and therefore prediction of resistance status.
 

Ceftriaxone-resistance Neisseria gonorrhoeae – FC428 clone
The FC428 clone was documented in Denmark in 2017 and the assay designed for detection of this clone uses primers designed against the PenA-60.001 allele and the A311V mutation. Resistance status is predicted by comparing the concentration of the FC428- ceftriaxone marker (calculated by the MT-PCR Results software) with the specific Neisseria gonorrhoeae markers opaJ and opaH.

 

How to use this panel as a primary screening?

If you are a smaller lab you could use panel 27113 as a primary screening. We also have a smaller panel that might be more suitable.
PS! If you don’t want to screen for M. genitalium as standard, the target can be switched off.
 

Urinogenital 8-well (Ref 27113)

 Ref 27113

  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Mycoplasma genialium
  • Trichomonas vaginalis
  • Mycoplasma hominis
  • Ureaplasma parvum
  • Ureaplasma urealyticum

Drug resistance MT-PCR panels

  • Detect and differentiate high-risk patients based on the presence of carbapenem resistance genes

  • Suitable for gram-negative bacterial infections including enterobacteriaceae, Acinetobacter baumanii, Pseudomonas aeruginosa

  • Test pure colonies harvested directly from culture plates without the need for DNA extraction, shortening sample-to-re sult time

 

CRE EU (16-well) panel (Ref 21099)
CRE EU (16-well) panel (Ref 21099) is intended to detect variants belonging to the 5 main families of Carbapenem-Resistant genes: KPC, NDM, VIM, IMP, and OXA-48 like; and that have been associated with Carbapenem-resistance.
 

Ref 21099

  • Metallo ß-lactamase VIM
  • Metallo ß-lactamase IMP
  • Metallo ß-lactamase 8
  • Metallo ß-lactamase IMP-14a
  • Klebsiella pneumoniae carbapenemase (KPC)
  • New Delhi Metallo-ß-lactamases (NDM)
  • Imipenemase resistance gene (IMI)
  • SME carbapenemase
  • GES ß-lactamase
  • SIM ß-lactamase
  • GM ß-lactamase
  • Colistin resistance
  • OXA-48-like ß-lactamase
  • ß-lactamase
  • FRI-1

 

Staphylococcus + VRE (8-well) (Ref 21340)
This panel is intended for the identification of the following pathogens and resistance genes in nucleic acid extracts and bacterial isolates:

Ref 21340

  • Staphylococcus aureus
  • Staphylococcus aureus femA
  • Methicilin resistance gene
  • Vancomycin resistance gene A
  • Vancomycin resistance gene B
  • Enterococcus faecium
  • Enterococcus faecalis

 

The evaluation of the CRE EU panel was carried by the Antimicrobial Resistance and Healthcare Associated Infections Reference Unit, National Infection Service, Public Health England, UK, concluded that this panel offered wide coverage for detection of acquired carbapenemase genes. It required minimal hands-on time and delivered results in less than 4 h from bacterial culture.

Danièle Meunier, Neil Woodford, Katie L Hopkins, Evaluation of the AusDiagnostics MT CRE EU assay for the detection of carbapenemase genes and transferable colistin resistance deter- minants mcr-1/-2 in MDR Gram-negative bacteria, Journal of Antimicrobial Chemotherapy, Volume 73, Issue 12, December 2018, Pages 3355–3358.
https://academic.oup.com/jac/article/73/12/3355/5091003  

Enteric pathogens MT-PCR panels

AusDiagnostics offers a wide range of enteric panels that detects enteric bacteria, parasites and virus. Here we choose to present some panels.
For a complete overview of all panels, please visit https://www.ausdiagnostics.com/enteric-infections.html
Depending on your needs, you can choose to combine small panels for your standard detection or a larger panel as your extended panel.


Faecal Pathogens M 16-well (Ref 25039)

The panel is is intended for simultaneous detection of 18 pathogen targets from a single faecal sample or culture.

STEC typing(16-well) (Ref 26131)
This panel can be used for further investigation of a wide range of shiga-producing E. coli as well as shiga toxin 1/2.

Ref 25039

  • Salmonella spp.
  • Shigella spp.
  • Campylobacter jejuni
  • Campylobacter coli
  • Clostridium difficile toxin A
  • Clostridium difficile toxin B
  • Yersinia pseudotuberculosis
  • Yersinia enterocolitica
  • Aeromonas spp.
  • Shiga toxin 1
  • Shiga toxin 2
  • Sapovirus
  • Rotavirus A
  • Norovirus genogroup I
  • Norovirus genogroup II
  • Adenovirus group F and G
  • Astrovirus
  • Giardia
  • Cryptosporidium (parvum and hominis)
  • Entamoeba histolytica

Ref 26131

  • Shiga toxin 1
  • Shiga toxin 2
  • EPEC
  • E.coli O26
  • E.coli O45
  • E.coli O103
  • E.coli O111
  • E.coli O113
  • E.coli O121
  • E.coli O128
  • E.coli O145
  • E.coli O157
  • E.coli saa
  • hylA
  • E.coli

 

The evaluation of AusDiagnostics MT-PCR system for detection and identification of 4 common pathogenic protozoan parasites from human clinical samples, carried out at the Department of Microbiology at St. Vincent's Hospital, Australia, demonstrated 100% correlation with the RT-PCR results, and compared to RT- PCR, MT-PCR exhibited 100% sensitivity and specificity.
 

Stark D, Al-Qassab SE, Barratt JL, Stanley K, Roberts T, Marriott D, Harkness J, Ellis JT. Evaluation of mul- tiplex tandem real-time PCR for detection of Cryptosporidium spp., Dientamoeba fragilis, Entamoeba histolytica, and Giardia intestinalis in clinical stool samples. J Clin Microbiol. 2011 Jan;49(1):257-62. doi:
10.1128/JCM.01796-10. Epub 2010 Nov 3. PMID: 21048004; PMCID: PMC3020426.

https://pubmed.ncbi.nlm.nih.gov/21048004/

 

For more information

Download our Molecular Diagnostics catalog with and overview of our products and services. 
And feel free to contact us for further information and product details.

 

 

   Product Specialist
   Tram Nguyen, Cand. Scient
   +45 3124 8581
   tn@bionordika.dk

 

 

 

 

Molecular Diagnostic, Products and services