A family of multiplex diagnostic tests and platform for mid to high-volume screening

Amplidiag® is a family of diagnostic tests for mid to high-volume screening of gastrointestinal pathogens and antibiotic resistances. The Amplidiag® product family consists of the Amplidiag® Easy instrument and Amplidiag®test kits that can be used with the instrument or manually.

Amplidiag® Easy takes the suite – unmatched in performance and capability – even further by automating the workflow from primary sample to final result.

Amplidiag® Analyzer Software a dedicated software eliminating the need for time-consuming manual interpretation of results by automating the necessary processes.

CE-IVD. For in vitro diagnostic use.

All Amplidiag® products are designed for mid to high-volume screening purposes. In many cases, automation of the workflow is important to minimize the amount of hands-on time and enhance the analysis process. Amplidiag® Easy automates the nucleic acid extraction and PCR plate setup for all Amplidiag® products.

It decreases the hands-on time for processing the samples and is also much faster than with other nucleic acid extraction / pipetting robot solutions. Due to the design, rapidity and ease-of-use of Amplidiag® Easy, it allows processing of several batches in a day to generate results faster than with any high-volume nucleic acid screening solution available.

Key Advantages

- Automated processing of stool samples from primary tubes to PCR plate
- Executes full workflow from sample to pipetted PCR plate for multiplex real-time PCR analysis – reliably and consistently
- One platform for nearly all stool testing purposes
- Fast - 48 samples in 2 hours
- Well-suited for mid to high-volume processing of stool samples

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Available Amplidiag® test kits

Amplidiag sensitive molecular test screening for H.pylori
Amplidiag H.pylori pcr test

H. pylori+ClariR

CE-IVD. For in vitro diagnostic use. The first product that reliably identifies Helicobacter pylori and clarithromycin resistance from stool samples and gastric biopsies. Amplidiag®H. pylori+ClariR is designed to be used as a testing method to guide primary eradication therapy for all patients. It is a non-invasive qualitative multiplex real-time PCR test for reliably identifying both H. pylori and clarithromycin resistance directly from stool sample DNA extract and gastric biopsies. It uses a novel, innovative integrated nested PCR method to detect H. pylori and its clarithromycin resistance within the same specific PCR product. Thus, the product has minimal cross-reactivity with closely related species.
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Sensitive molecular test screening for GI pathogens
Amplidiag Bacterial GE pcr test kit

Bacterial GE

CE-IVD. For in vitro diagnostic use. Reliable and robust qualitative multiplex real-time PCR in vitrodiagnostic screening test for bacterial pathogens from stool samples without pre-culturing. NEW TEST VERSION! Disease control authorities in Denmark and Sweden have included requirements to distinguish EHEC related Shiga-toxin gene variants (Stx) in their national guidelines. Higher risk from hemolytic uremic syndrome (HUS) is associated with strains positive eae and Stx2 genes only. Separation of Stx genes allow focusing clinical and laboratory effort to cases that require special attention. To respond to this request Mobidiag has included changes to the target gene identification related to EHEC. The NEW Amplidiag Bacterial GE now allows discrimination between Stx1 and Stx2 variants.
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Sensitive molecular screening for antimicrobial resistance VRE
Amplidiag CarbaR+VRE PCR kit

CarbaR+VRE

CE-IVD. For in vitro diagnostic use. Amplidiag® CarbaR+VRE identifies clinically most relevant carbapenemase groups as well as vancomycin resistance markers in one single test. This molecular diagnostic test has been designed to be a cost-effective solution for high-volume screening from stool samples, rectal swabs or pure culture samples for the diagnosis of carbapenemase-producing organisms (CPO) and vancomycin-resistant Enterococci (VRE). This qualitative multiplex real-time PCR test gives results within a few hours, as opposed to days with culture-based screening methods. By allowing rapid and reliable detection of antibiotic resistances, Amplidiag CarbaR+VRE supports decisions to manage efficiently epidemiological and infection control measures and improve patient care.
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Sensitive molecular test screening for antimicrobial resistance MCR
Mobidiag's Amplidiag CarbaR+MCR pcr test kit

CarbaR+MCR

CE-IVD. For in vitro diagnostic use. Amplidiag® CarbaR+MCR identifies clinically most relevant carbapenemase groups as well as colistin resistance markers in one single test. This molecular diagnostic test has been designed to be a cost-effective solution for high-volume screening directly from stool, rectal swabs and pure culture samples for the diagnosis of carbapenemase-producing organisms (CPO) and colistin-resistant Enterococci (CRE). This qualitative multiplex real-time PCR test gives results within a few hours, as opposed to days with culture-based screening methods. By allowing rapid and reliable detection of antibiotic resistances, Amplidiag CarbaR+MCR supports decisions to manage efficiently epidemiological and infection control measures and improve patient care.
Contact sales@mobidiag.com or fill in the form below for more information and orders.

Sensitive molecular test screening for stool parasites
Amplidiag stool parasites pcr kit

Stool Parasites

CE-IVD. For in vitro diagnostic use. Amplidiag® Stool Parasites identifies the four most frequent enteric parasites rapidly from a single stool sample in a single reaction. This qualitative multiplex real-time PCR test is designed to be used as the primary screening method for stools incoming for parasite analysis. The current screening method, microscopy, is laborious, prone to errors and requires substantial expertise. Amplidiag Stool Parasites allows effective detection of Cryptosporidium spp., Giardia lamblia, Entamoeba histolytica and Dientamoeba fragilis. Microscopy can be targeted to samples which need further investigation, making the screening process more effective and accurate.
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Amplidiag sensitive molecular screening for GI viruses
Amplidiag Viral GE pcr kit

Viral GE

CE-IVD. For in vitro diagnostic use. Amplidiag® Viral GE identifies the five clinically most important enteric viruses rapidly from a single stool sample, and the test covers all clinically relevant subgroups. The sample material is total nucleic acid extracted from a stool. While rotavirus, astrovirus, and adenovirus are the predominant causes of gastroenteritis in children less than five years old, norovirus and sapovirus cause diarrhea in patients of all ages. This comprehensive test allows you to screen relevant viral pathogens at once, without parallel or subsequent testing.
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Sensitive molecular test screening for C.difficile

C. difficile+027

CE-IVD. For in vitro diagnostic use. Amplidiag® C. difficile+027 identifies toxin B gene in C. difficile and differentiates between the hypervirulent 027 ribotype and non-027 ribotypes, from a single stool sample in a single qualitative multiplex real-time PCR assay.
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