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Syndromic testing

Syndromic testing for GI infections with QIAstat-Dx

Get accurate results for gastrointestinal infections

Conventional methods for detecting gastrointestinal infections, like microscopy and culture, are slow and cumbersome. And while syndromic testing can provide superior results, not all tests are made equal.

That’s why you need QIAstat‑Dx Gastrointestinal Panel 2. Our test uses trusted QIAGEN chemistry, backed by 40 years of expertise in molecular biology.

Get reliable, accurate results for your patients using QIAstat‑Dx Gastrointestinal Panel 2.

Differentiating stx1 and stx2 in Shiga-like toxin-producing E. coli (STEC) is crucial

Analyzing our QIAsphere Insights epidemiology data from 2023, we saw a greater incidence of stx2-producing STEC detections (1.9% of total) compared to stx1-producing STEC detections (0.7% of total) (1).

This is important because:

  • stx2 is strongly associated with severe disease outcomes (2), including hemolytic uremic syndrome (HUS), a serious condition that can lead to kidney failure
  • Importantly, antibiotics are contraindicated for patients with STEC infection, as they can increase the risk of HUS (3)
  • The fast identification of stx2 can help reduce the risk for serious complications, guide patient management and improve overall patient outcomes
QIAstat-Dx detections of stx1-, stx2- and stx1+stx2-positive STEC in 2023.
Isolates of stx2f-positive E. coli in the UKHSA archives, adapted from (5).
Caution around detecting stx2f-producing STEC, subtype of concern

Leading public health organizations, such as the ECDC and the UK Health Security Agency, have recently highlighted a notable increase in gastrointestinal illnesses linked to stx2f.

This stx subtype is now recognized as a significant emerging threat (4,5).

  • Due to its genetic divergence from other stx2 subtypes, standard PCR primers can fail to detect stx2f, leading to potential underreporting (4)
  • Unlike some other syndromic tests, QIAstat‑Dx Gastrointestinal Panel 2 effectively detects the stx2f subtype (6,7), ensuring comprehensive diagnostic coverage
Gastrointestinal co-detections are an important contributor to positive tests

Double, triple and even quadruple gastrointestinal co-detections are common, especially in children (8).

Our QIAsphere data corroborates this. We see a variety of co-detection types, including triple detections between a virus, bacteria and parasite (1).


Ct values can help you understand co-detections

When two or more pathogens are co-detected, doctors need to decide which pathogen to act on. This can impact the choice of treatment. Antibiotics that are appropriate for one co-detection (e.g., EPEC and Shigella) might be contraindicated for another (e.g., STEC stx2 and Salmonella).

In cases like these, additional insights from cycle threshold (Ct) values can aid in clinical interpretation.

Co-infection rates based on all positive detections between January – December 2023 (1).
Clinical case: Seeing beyond the gastrointestinal symptoms with Ct values

Provided by Liliana Gabrielli, MD, Microbiology Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Policlinico di Sant'Orsola, Italy.

  • 1.5-year-old child admitted with vomiting, diarrhea and seizures; Suspected hypoglycemia
  • QIAstat-Dx Gastrointestinal Panel 2 result came back quickly as positive for: Norovirus (Ct: 17.8); Enteroaggregative E. coli (EAEC; Ct: 29.7); Enteropathogenic E. coli (EPEC; Ct: 32.2); Clostridium difficile toxin A/B (Ct: 30.4)
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Amplification curves for positive detections: Norovirus (Ct: 17.8); Enteroaggregative E. coli (EAEC; Ct: 29.7); Enteropathogenic E. coli (EPEC; Ct: 32.2); Clostridium difficile toxin A/B (Ct: 30.4)
  • Outcome: The low Ct value (17.8) for norovirus supported the clinical diagnosis of norovirus infection. EAEC, EPEC and Clostridium difficile were probably correlated with co-infection/colonization.
  • Comprehensive testing is crucial, but additional information may be necessary for clinical interpretation. That's where QIAstat‑Dx stands out, providing easy access to Ct values and amplification curves for enhanced clinical insights.
Female surgeon at the operating table
QIAstat‑Dx Gastrointestinal Panel 2 for immunocompromised lung transplant patients

According to Laurence Armand-Lefevre, PhD, PharmD, Professor of Microbiology at University of Paris Cité and Head of the Bacteriology Department at Bichat-Claude Bernard Hospital, France:

"A few months after the implementation of the QIAstat‑Dx [gastrointestinal panel], physicians in charge of the immunocompromised lung transplant patients asked us to perform multiplex PCR tests for all their patients, whatever their date of hospitalization. Lung transplant patients frequently have diarrhea and the physician needs to know is this diarrhea an adverse effect of the immunosuppressive treatment, which occurs frequently, or due to the acquisition of a GI pathogen. This test was of particular interest for them."

The importance of accurate detection

To provide timely care, you need accurate results. False negatives and false positives can be a major stumbling block. A missed positive can impact on infection control and delay time to appropriate treatment.

False positives can also have serious consequences, masking the true cause of symptoms. A delay in diagnosis, unnecessary implementation of infection control measures and increased hospital costs are all possible.

Norovirus false positives, for example, can have a negative impact on immunocompromised and oncology patients. These patients often experience diarrhea that goes undiagnosed. Accurate pathogen detection – or lack of detection – can improve their clinical management (11).

The QIAstat-Dx Gastrointestinal Panel 2 has a demonstrated specificity of 99.95% for norovirus, ensuring accurate results (9).

mature male patient, caretaker, wheeled chair
Rapid molecular syndromic testing for aetiological diagnosis of gastrointestinal infections and targeted antimicrobial prescription: experience from a reference paediatric hospital in Spain

Castany-Feixas M, Simo S, Garcia-Garcia S, et al. Eur J Clin Microbiol Infect Dis. 2021;40(10):2153-2160. doi:10.1007/s10096-021-04266-7

Explore how our QIAstat-Dx gastrointestinal panel enhances the etiological diagnosis of gastrointestinal infections in children, as demonstrated in our groundbreaking study at Sant Joan de Deu Barcelona Hospital. Our findings reveal that the QIAstat-Dx panel significantly outperforms conventional methods, detecting a higher number of infections and improving the accuracy of diagnostic results.

Read the study

 

Be aware of Shiga-toxin 2f-producing Escherichia coli: Case report and false-negative results with certain rapid molecular panels

Cointe A, Birgy A, Pascault A, et al. Diagn Microbiol Infect Dis. 2020;98(4):115177. doi:10.1016/j.diagmicrobio.2020.115177

Learn how our QIAstat-Dx gastrointestinal panel stands out as one of the few multiplex gastrointestinal panels capable of detecting the elusive stx2f subtype. Identifying this subtype is crucial for diagnosing EHEC infections and preventing severe outcomes like hemolytic uremic syndrome. This unique capability, along with our panel’s precise differentiation between stx1 and stx2, ensures heightened vigilance and accuracy in clinical diagnostics.

Read the study

 

Epidemiology of gastrointestinal infections: Lessons learned from syndromic testing, Region Zealand, Denmark

Johansen RL, Schouw CH, Madsen TV, Nielsen XC, Engberg J. Eur J Clin Microbiol Infect Dis. 2023;42(9):1091-1101. doi:10.1007/s10096-023-04642-5

Discover how our QIAstat-Dx gastrointestinal panel has transformed our understanding of gastrointestinal infections over a year-long study in Denmark. The findings underscore the critical role of comprehensive diagnostic testing in uncovering the complex epidemiology of key diarrheal pathogens. See how this in-depth knowledge supports optimal clinical care and public health strategies.

Read the study

I think that [Ct values] can help in the interpretation of the results, in particular in case of co-infections, in order to understand what is the virus or the bacteria that is probably more correlated with the clinical problem.
Liliana Gabrielli, MD, Microbiology Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Policlinico di Sant'Orsola, Italy
It's clear. [The technicians in my lab] love the QIAstat-Dx. Because it's really easy to use… Because they feel that the search for pathogens is smarter.
Laurence Armand-Lefevre, PhD, PharmD, University of Paris Cité, Bichat-Claude Bernard Hospital, France
MDx ST QIAstatDx Gastrointestinal
Identify the true culprit in co-infections and improve GI care

With QIAstat‑Dx Gastrointestinal Panel 2, detect and differentiate 23 bacterial, viral and parasitic targets, including separate detection of Shiga-like toxin-producing E.coli (STEC) stx1 and stx2. The benefits of syndromic testing extend through the lab, hospital and to the patients. Read why you should use QIAstat‑Dx syndromic testing for GI infections in our brochure.

QIAstat-Dx, QIAstat-Dx analyzer, syndromic testing, instrument, cartridge
Break boundaries in digital healthcare with QIAstat‑Dx Analyzer 2.0

QIAstat‑Dx just got an upgrade – and it's a doozy. Say hello to the QIAstat‑Dx Analyzer 2.0, where the digital revolution in medicine begins. Now you can review and confirm results from any location, paving the way for effortless collaboration between central and regional labs. The QIAstat‑Dx Analyzer 2.0 isn't just an upgrade; it's a giant leap towards a smarter, more interconnected healthcare future.

References

1. From QIAstat-Dx Gastrointestinal Panel 2 (Cat. No. 691412) epidemiology dashboards in QIAsphere Insights, January 2023 – December 2023 for EMEA.
2. Orth D, Grif K, Khan AB, Naim A, Dierich MP, Würzner R. The Shiga toxin genotype rather than the amount of Shiga toxin or the cytotoxicity of Shiga toxin in vitro correlates with the appearance of the hemolytic uremic syndrome. Diagn Microbiol Infect Dis. 2007;59(3):235-242. doi:10.1016/j.diagmicrobio.2007.04.013
3. Mühlen S, Dersch P. Treatment Strategies for Infections With Shiga Toxin-Producing Escherichia coli. Front Cell Infect Microbiol. 2020 May 6;10:169. doi: 10.3389/fcimb.2020.00169. PMID: 32435624; PMCID: PMC7218068.
4. European Centre for Disease Prevention and Control Annual Epidemiological Report 2021 – STEC https://www.ecdc.europa.eu/sites/default/files/documents/AER%20STEC%20-%202021.pdf. Accessed February 7, 2024
5. Den Ouden A, Greig DR, Rodwell EV, et al. Escherichia coli encoding Shiga toxin subtype Stx2f causing human infections in England, 2015-2022. J Med Microbiol. 2023;72(6):10.1099/jmm.0.001707. doi:10.1099/jmm.0.001707
6. Engberg J, Vejrum LK, Madsen TV, Nielsen XC. Verification of analytical bacterial spectrum of QIAstat-Dx® GI V2 and Novodiag® Bacterial GE+ V2-0 diagnostic panels. J Antimicrob Chemother. 2021;76(Suppl 3):iii50-iii57. doi:10.1093/jac/dkab242
7. Cointe A, Birgy A, Pascault A, et al. Be aware of Shiga-toxin 2f-producing Escherichia coli: case report and false-negative results with certain rapid molecular panels. Diagn Microbiol Infect Dis. 2020;98(4):115177. doi:10.1016/j.diagmicrobio.2020.115177|
8. Johansen RL, Schouw CH, Madsen TV, Nielsen XC, Engberg J. Epidemiology of gastrointestinal infections: lessons learned from syndromic testing, Region Zealand, Denmark. Eur J Clin Microbiol Infect Dis. 2023 Sep;42(9):1091-1101. doi: 10.1007/s10096-023-04642-5. Epub 2023 Jul 19. PMID: 37468662; PMCID: PMC10427544. Study performed using QIAstat-Dx Gastrointestinal Panel (V1).
9. Data presented is for the QIAstat-Dx Gastrointestinal Panel 2 (Cat. No. 691412); QIAstat-Dx Gastrointestinal Panel 2 Instructions for Use. QIAGEN, February 2023
10. Castany-Feixas M, Simo S, Garcia-Garcia S, et al. Rapid molecular syndromic testing for aetiological diagnosis of gastrointestinal infections and targeted antimicrobial prescription: experience from a reference paediatric hospital in Spain. Eur J Clin Microbiol Infect Dis. 2021;40(10):2153-2160. Study performed using QIAstat-Dx Gastrointestinal Panel 2.
11. Rogers WS, Westblade LF, Soave R, et al. Impact of a Multiplexed Polymerase Chain Reaction Panel on Identifying Diarrheal Pathogens in Hematopoietic Cell Transplant Recipients. Clin Infect Dis. 2020;71(7):1693-1700. doi:10.1093/cid/ciz1068

QIAsphere data from connected institutions were used for scientific research purposes only after applying proper de-identification procedures and anonymization techniques, in accordance with HIPAA and GDPR privacy and data protection rules. Data is aggregated from QIAsphere-connected QIAstat-Dx instruments only.

Unless otherwise indicated, data cited pertains to the use of a device from another manufacturer.

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