Amplidiag®

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.

• Helicobacter pylori 23S rRNA gene
• Clarithromycin resistance: SNPs at sites 2142 and 2143 of 23S rRNA gene

• Identification of H. pylori and clarithromycin resistance gene mutations
• Identification of H. pylori: Sensitivity 91,4%, Specificity 99.2%
• Identification of clarithromycin resistance gene mutations: Sensitivity 100.0%, Specificity 100.0%
• CE-IVD
• Product no: AD-HP-80
• Package size: 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: DNA extracted from stool or gastric biopsies

• Non-invasive: directly from DNA extract of stool sample
• Identify both H. pylori and clarithromycin resistance to guide effective primary therapy
• Suited for high-volume screening
• Automated results analysis with Amplidiag® Analyzer software
• Option for workflow automation with Amplidiag® Easy
• Potential to lower therapy failures and decrease the number of gastroscopies and biopsies in low-risk patients
• Contribute to the fight against gastric cancers with increased primary eradication therapy success rates
• Reduce overall healthcare costs related to diagnostics, treatment, and complications of H. pylori infection

• J Clin Microbiol. 2020 Jan 29. doi:10.1128/JCM.01787-19
  Diagnostic accuracy of a non-invasive test for the detection of Helicobacter pylori and resistance to clarithromycin in stool by Real-Time PCR Amplidiag® H. pylori + ClariR assay
  Pichon M, Pichard B, Barrioz T, Plouzeau C, Croquet V, Fotsing G, Chéron A, Vuillemin É, Wangermez M, Haineaux P-A, Vasseur P, Thiebault Q, Lefèvre C, Singly A, Cremniter J, Broutin L, Michaud A, Silvain C, Burucoa C
  Access full publication
• Helicobacter. 2018 Dec 12:e12560. doi: 10.1111/hel.12560
  Molecular diagnosis of Helicobacter pylori infection in gastric biopsies: Evaluation of the Amplidiag® H. pylori + ClariR assay
  Hays C, Delerue T, Lamarque D, Burucoa C, Collobert G, Billöet A, Kalach N, Raymond J.
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• Spectra biologie n°236, September-October 2018, pp. 44-45
  The article presents the results of the multicentric prospective study carried out in the framework of the Hepystool Hospital Clinical Research Project on 1,200 patients with the evaluation of the multiplex qPCR test Amplidiag® H. pylori+ClariR directly from stool samples.
  Read full article in English Read full article in French

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.

• EHEC (enterohemorrhagic E. coli)
• EPEC (enteropathogenic E. coli)
• ETEC (enterotoxigenic E. coli)
• Yersinia
• Campylobacter
• Shigella spp. /EIEC (enteroinvasive E. coli)
• EAEC (enteroaggregative E. coli)
• Salmonella spp.

• Sensitivity 99.0%
• Specificity 99.9%
• Discriminate between eae, Stx1 and Stx2 variants
• CE-IVD
• Product no: AD-BGE-100
• Package size : 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: DNA extracted from stool

• Streamline your laboratory process and sample flow!
• Optimize your stool sample screening process
• Detect eight pathogens simultaneously with a single assay
• Get access to more clinically relevant information compared to conventional methods
• Report same-day results (2 hrs turnaround time)
• Runs on multiplex real-time PCR technology for optimal performance
• Automated and easy result analysis with Amplidiag® Analyzer software

• Pediatr Infect Dis J. 2018 May;37(5):424-428
  Potential Diarrheal Pathogens Common Also in Healthy Children in Angola
  Pelkonen T,Dos Santos MD, Roine I, Dos Anjos E, Freitas C, Peltola H, Laakso S, Kirveskari J
  See full publication
• Journal of Microbiological Methods 128 (2016) 61–65
  Evaluation of a multiplex real-time PCR kit Amplidiag® Bacterial GE in the detection of bacterial pathogens from stool samples
  Anniina Rintala, Eveliina Munukka, Andrej Weintraub, Måns Ullberg, Erkki Eerola.
  See full publication
• Clin Microbiol Infect 2016; 22: 535–541
  Prospective study of pathogens in asymptomatic travellers and those with diarrhoea: aetiological agents revisited
  T. Lääveri, J. Antikainen, S. H. Pakkanen, J. Kirveskari, A. Kantele.
  See full publication

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.

• KPC
• NDM
• VIM
• OXA-48, OXA-181
• IMP
• Acinetobacter OXA* (ISAba1-OXA-51, OXA-23, OXA-24/40, OXA-58)
• vanA (vanA gene)
• vanB (vanB1, vanB2 and vanB3 genes)

*See detailed variant information from the user manual

• Result analysis and reporting: Automated with Amplidiag® Analyzer software
• CE-IVD
• Product no: AD-CP-100
• Package size: 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: DNA extracted from stool samples, rectal swabs and pure culture

• DNA extracted from stool samples, rectal swabs or pure culture sample
• Rapidly screen the presence of CPO and VRE
• All targets detected and reported in a single test, from a single sample
• Suited for high-volume screening
• Automated results analysis with Amplidiag® Analyzer software
• Option for workflow automation with Amplidiag® Easy
• Effectively guides infection control measures and reduces epidemics

• J Clin Microbiol. 2018 Feb 22;56(3). pii: e01092-17. doi: 10.1128/JCM.01092-17 Evaluation of the Amplidiag CarbaR+VRE Kit for Accurate Detection of Carbapenemase-Producing Bacteria Oueslati S, Girlich D, Dortet L, Naas T. See full publication

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.

• KPC
• NDM
• VIM
• IMP
• OXA-48, OXA-181
• Acinetobacter OXA* (ISAba1-OXA-51, OXA-23, OXA-24/40, OXA-58
• MCR (MCR-1, MCR-2)
• GES (GES-2, GES-4 through GES-6, GES-13 through GES-16, GES-18, GES-20, GES-21, GES-24)

• Flexible sample formats
• All targets detected and reported in one single test, from one single sample
• Automated results analysis with Amplidiag® Analyzer software
• Workflow automation with Amplidiag® Easy
• CE-IVD
• Product no: AD-CPM-100
• Package size: 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: stool samples, rectal swabs and pure culture

• DNA extracted from stool samples, rectal swabs or pure culture sample
• Rapidly screen the presence of CPO and VRE
• All targets detected and reported in a single test, from a single sample
• Automated results analysis with Amplidiag® Analyzer software
• Option for workflow automation with Amplidiag® Easy
• Effectively guides infection control measures and reduces epidemics

• ECCMID Congress, April 2019,
  Molecular carbapenemase tests Eazyplex SuperBug Complete B, Novodiag CarbaR+, and Amplidiag CarbaR+MCR, provide high sensitivity in the detection of carbapenemase-positive bacteria,
  Tanja Holma, Jenni Antikainen, Anu Pätäri-Sampo, and Johanna Haiko, Helsinki University and Helsinki University Hospital, HUSLAB, Department of Clinical Microbiology, Helsinki, Finland.
  See full publication
• J Clin Microbiol. 2019 March 57. pii: JCM.01800-18. doi: 10.1128/JCM.01800-18
  Evaluation of the Amplidiag CarbaR + MCR kit for the accurate detection of carbapenemase-producing and colistin-resistant bacteria
  Girlich D, Bernabeu S, Grosperrin V, Langlois I, Begasse C, Arangia N, Creton E, Cotellon G, Sauvadet A, Dortet L, Naas T.
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• J Clin Microbiol. 2018 Dec 12. pii: JCM.01800-18. doi: 10.1128/JCM.01800-18
  Evaluation of the Amplidiag CarbaR + MCR kit for the accurate detection of carbapenemase-producing and colistin-resistant bacteria
  Girlich D, Bernabeu S, Grosperrin V, Langlois I, Begasse C, Arangia N, Creton E, Cotellon G, Sauvadet A, Dortet L, Naas T.
  See full publication

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.

• Cryptosporidium spp.
• Giardia lamblia
• Entamoeba histolytica
• Dientamoeba fragilis

• Result analysis and reporting: Automated with Amplidiag® Analyzer software
• CE-IVD
• Product no: AD-SP-100
• Package size: 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: DNA extracted from stool

• Directly from DNA extracted from stool
• Optimize stool parasite screening by detecting the most common pathogens by multiplex real-time PCR
• Target microscopic analysis only to samples needing further investigation
• All targets detected and reported from a single sample
• Suited for high-volume screening
• Automated results analysis with Amplidiag® Analyzer software
• Option for workflow automation with Amplidiag® Easy

• Pediatr Infect Dis J. 2018 May;37(5):424-428
  Potential Diarrheal Pathogens Common Also in Healthy Children in Angola
  Pelkonen T,Dos Santos MD, Roine I, Dos Anjos E, Freitas C, Peltola H, Laakso S, Kirveskari J
  See full publication

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.

• Norovirus GI
• Norovirus GII
• Rotavirus A
• Sapovirus
• Astrovirus
• Adenovirus 40 and 41

• Result analysis and reporting: Automated with Amplidiag® Analyzer software
• CE-IVD
• Product no: AD-VGE-100
• Package size: 96 tests
• Product format: Multiplex real-time PCR kit
• Sample material: Nucleid acid extracted from stool

• Directly from nuclei acid extracted from stool sample
• Test comprehensively the five most important viral enteric pathogens from one sample
• No parallel or subsequent testing to find the causative agent or to rule out pathogens
• All targets detected and reported in a single test
• Suited for high-volume screening
• Automated results analysis with Amplidiag® Analyzer software
• Option for workflow automation with Amplidiag® Easy
• Generate rapid information for infection control and patient management

• Pediatr Infect Dis J. 2018 May;37(5):424-428
  Potential Diarrheal Pathogens Common Also in Healthy Children in Angola
  Pelkonen T,Dos Santos MD, Roine I, Dos Anjos E, Freitas C, Peltola H, Laakso S, Kirveskari J
  See full publication

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.

• C. difficile tcdB gene (toxin B gene)
• Novel 027 positive marker
• Novel 027 negative marker

• Identification of toxin B gene in C. difficile: Sensitivity 97.8%, Specificity 100.0%
• Identification of  027 ribotype: Sensitivity 94.1%, Specificity 100.0%
• CE-IVD
• Product no: AD-CD-300
• Package size: 288 tests
• Product format: Multiplex real-time PCR kit
• Sample material: DNA extracted from stool

• Catch pathogenic C. difficile and its 027 ribotype at the screening phase
• Detect pathogenic C. difficile strains directly from stool sample
• Discriminate reliably between hypervirulent 027 ribotype and non-027 ribotypes
• Directly from DNA extract from a stool sample
• Rapid and easy-to-use single-reaction qualitative multiplex real-time PCR test
• Cost-effective solution for mid-to-high throughput laboratories
• Report same-day results
• Runs on multiplex real-time PCR technology for optimal performance
• Automated and easy result analysis with Amplidiag® Analyzer software

• Anaerobe, Volume 52, August 2018, Pages 111-114
  Evaluation of a novel molecular assay to diagnose toxigenic strains of Clostridium difficile
  Catherine Eckert,Thomas Devallière, Rabab Syed-Zaidia, Valérie Lalande, Frédéric Barbut.
  See full publication
• Expert Review of Molecular Diagnostics , Volume 15, 2015 - Issue 9
  Differentiating virulent 027 and non-027 Clostridium difficile strains by molecular methods
  Silja Mentula, Sanna Laakso, Outi Lyytikäinen, Juha Kirveskari.
  See full publication

Now available as an emergency use test in Finland, Sweden and France (coming soon in UK).

Amplidiag® COVID-19 test allows the rapid detection of novel coronavirus (also called SARS-CoV-2). By allowing rapid and reliable detection of this novel coronavirus, this qualitative real-time RT-PCR test supports decisions to manage efficiently epidemiological and infection control measures, isolate patients in a timely manner and improve patient care globally.

• SARS-CoV-2 (orf1ab)
• SARS-CoV-2 (N)

Amplidiag® COVID-19 detects 2 molecular targets  including at least one conserved region and one specific region to mitigate against the effects of genetic drift and avoid cross-reaction with other endemic coronaviruses.

Now available as an emergency use test in Finland and Sweden (coming soon in France and UK )

• Product no: AD-CV-864
• Package size: 864 tests
• Product format: Amplification kit for multiplex RT-PCR
• Sample material: RNA extracted from nasopharyngeal sample

• Detection at early infection stage
• Two molecular targets to avoid cross-reaction with other endemic coronaviruses and genetic drift of SARS-CoV-2
• Large volumes
• Runs on multiplex RT-PCR technology for optimal performance
• Automated and easy result analysis with Amplidiag® Analyzer software
• Workflow automation possible with Amplidiag® Easy:
  - Automated process for DNA extraction and PCR set up
  - Streamline your laboratory process and sample flow
  - Optimize your sample screening process
  - Report same-day results (48 samples in <3h turnaround time)

• Coming soon