Multiplex Gastrointestinal Pathogen Simplicity Panel™

Simplified GI Multiplex PCR Testing Has Arrived 

Key takeaways:

• Gastrointestinal (GI) infectious disease is a serious public health issue and the demand for GI pathogen testing is constant. Reference laboratories may benefit by adding GI multiplex PCR testing to their test menus.
• Multiplex PCR enables rapid and accurate detection of GI pathogens with higher detection 
  rates when compared to traditional GI workups.
• The new Gastrointestinal Pathogen Simplicity panel™ from Molecular Designs offers unique features that make it ideal for use in busy laboratories.

Introduction

Acute gastroenteritis (AGE) is a common occurrence in the US, often marked by nausea, stomach cramping, diarrhea, maybe even a fever. The traditional way to determine if the illness is viral and therefore self-limiting, or the start of something more serious, is to perform a full gastrointestinal (GI) workup (1). But stool cultures, antigen testing, cytology, microscopic examination, and more, that workup can take days and time is of the essence (1).

Multiplex polymerase chain reaction (PCR) testing offers an attractive alternative. It’s more sensitive, utilizes a much simpler laboratory workflow to screen for multiple pathogens in one test, and can deliver same-day results. For hospitals and reference laboratories, this means that adopting multiplex PCR panel testing for GI pathogens can save time and reduce costs.

The new research use only (RUO) Gastrointestinal Pathogen Simplicity Panel™ from Molecular Designs enables the rapid and accurate detection of GI pathogens, can lower healthcare costs associated with AGE, and supports improved antibiotic stewardship. Read on to find out more about the benefits of multiplex PCR testing for GI pathogens and the unique advantages of the Simplicity Panel™.

GI infectious disease: a significant public health concern

Demand for GI pathogen testing is constant. A CDC-sponsored study estimates that AGE from all causes accounts for 179 million illnesses in the US annually (2). The largest cause of AGE in the US is foodborne GI infections – approximately 48 million people, or 1 in 6 adults, will suffer from foodborne illness each year (3), (4). In addition, travel-associated incidences and AGE spread in close community settings contribute to a high prevalence of GI infections that result in 128,000 hospitalizations, nearly 3,000 deaths, and an estimated healthcare cost burden of $264 million per year (1),(3).

Multiplex GI panels can play an important role in reference laboratory testing, public health monitoring programs, and outbreak investigations by rapidly identifying pathogens, helping reduce the spread of disease, and lowering costs associated with AGE testing.

Rapid, accurate GI pathogen detection enabled by multiplex PCR

Gastroenteritis can be caused by a wide range of bacterial, viral, and parasitic pathogens, all of   which produce similar symptoms (1). The only way to determine what type of pathogen is at work is to perform testing. Traditional GI workups may require multiple, pathogen-specific tests to be run in parallel, which is not only logistically difficult – often requiring more than one sample and coordination with several different labs – but costly too.

Long turnaround times – 32 hours on average for a standard workup – result in delayed care decisions, meaning that the patient suffers longer, is at an increased risk of hospitalization, and may be given antibiotics that aren’t necessary (1). To make matters worse, the lower sensitivities of traditional tests lead to a failure to find a microbial cause in over half of cases of AGE (1).

In contrast, a recent study showed a multiplex PCR panel with at least 12 targets can yield results from a single stool sample within one day – an average of 6.3 hours – and the sensitivity of this technique allowed 73% of AGE cases to be linked to a GI pathogen (1). Positive identification of the pathogen responsible for AGE eliminates much of the guesswork involved in treatment and, as shown in the CDC-sponsored study, enables the use of fewer antibiotics in alignment with antibiotic stewardship practices (1),(5),(6),(7). All these factors combined make multiplex PCR panel testing an attractive option for GI pathogen detection.

As public health researchers and laboratories increasingly adopt multiplex PCR testing for GI pathogens, Molecular Designs’ new Gastrointestinal Pathogen Simplicity Panel™ (RUO) is a timely addition to any laboratory service menu (8). Not only does the panel deliver fast, cost-effective results, but several unique features make it optimal for use in busy reference laboratories.

The Gastrointestinal Pathogen Simplicity™ Panel (RUO)

The Gastrointestinal Pathogen Simplicity Panel™ is a highly accurate and sensitive multiplex PCR assay, for research use only, that identifies nucleic acids from 16 different organisms (Table 1) commonly associated with GI infections – all from a single sample. 

Molecular Designs created this panel with cost effectiveness and ease of use at top of mind. Because the reagents for Simplicity Panels™ come added to the PCR plate, the workflow has just two simple steps once the sample is extracted: add the extracted samples and start the thermocycler. Assays are compatible with most quantitative real-time PCR instruments with at least 4 channel. Simplicity™ panels save valuable technician time on each test, offer a better user experience, and enable higher testing throughput.

The Simplicity Panel™ minimizes reagent and consumable waste by providing fully loaded plates. Even with the best pipetting technique, approximately 10% of the master mix volume is lost during plating (learn more about optimizing PCR profitability here) and the potential for error is higher. The fully loaded plate are QC tested to ensure consistency across assays. Furthermore, Molecular Designs offers a unique 96-well breakaway plate format designed to accommodate one sample in each column, so that users can fill only the columns needed and store the remainder of the plate for future use (Figure 1). For larger testing volumes, the panel is also available in a bulk tube format. 

Figure 1. The Gastrointestinal Pathogen Simplicity Panel™ (RUO) is available in a breakaway 96-well plate format for maximum convenience and minimum waste.

Simplicity Panels™ are manufactured by Molecular Designs to GMP and ISO 13485:2016 standards. With the exception of the COVID-19 EUA, all products are for research use only and not for use in diagnostic procedures. Molecular Designs serves as a single supplier for reagents, reducing the need for labs to source reagents from multiple vendors and balance inventory or manage supplier lead times. Furthermore, for reference laboratories and hospitals interested in developing the assays for diagnostic use, Molecular Designs offers validation assistance through our Streamline Scientific team.

With increased sensitivity and same-day turnaround, multiplex PCR pathogen panels are replacing traditional GI workups as the test of choice for gastrointestinal pathogen detection and helping to meet the consistent demand for GI infectious disease testing. 

Learn more about the benefits of the Gastrointestinal Pathogen Simplicity Panel™. 

References

1. Moon, R.C., et al. Relationship between Diagnostic Method and Pathogen Detection, Healthcare Resource Use, and Cost in U.S. Adult Outpatients Treated for Acute Infectious Gastroenteritis. J Clin Micro. 61:2.16 Jan 2023. https://doi.org/10.1128/jcm.01628-22.

2. Schmidt, M. A., et al. Incidence, Etiology, and Healthcare Utilization for Acute Gastroenteritis in the Community, United States. Emerg Infect Dis, 28(11), 2234-2242. (2022). https://doi.org/10.3201/eid2811.220247.

3. Estimates of Foodborne Illness in the United States. Centers for Disease Control and Prevention. [Accessed 14 Apr 2023]. https://www.cdc.gov/foodborneburden/index.html

4. What You Need to Know about Foodborne Illnesses. U.S. Food & Drug Administration. [Accessed 14 Apr 2023]. https://www.fda.gov/food/consumers/what-you-need-know-about-foodborne-illnesses

5. Smith, D. G. This Stomach Bug Isn’t Responding to Antibiotics. Scientists Are Worried. New York Times. 8 Mar 2023. https://www.nytimes.com/2023/03/08/well/live/shigella-bacteria-stomach-bug-antibiotics.html

6. ASM Communications. PCR Panels Reduce Costs, Hospitalizations and Antibiotic Use for Acute GI Infections. American Society for Microbiology. 15 Mar 2023. https://asm.org/Press-Releases/2023/March/PCR-Panels-Reduce-Costs,-Hospitalizations-and-Anti

7. Core Elements of Antibiotic Stewardship. Centers for Disease Control and Prevention. [Accessed 27 Apr 2023]. https://www.cdc.gov/antibiotic-use/core-elements/

8. O’Keeffe, J. (2021). Wastewater-based epidemiology: current uses and future opportunities as a public health surveillance tool. Environmental Health Review. 64(3): 44-52. 3 Nov 2021. https://pubs.ciphi.ca/doi/full/10.5864/d2021-015