Review of the role of gastrointestinal multiplex polymerase chain reaction in the management of diarrheal illness

Abstract

Acute and chronic diarrheal illness secondary to gastrointestinal infection is a significant cause of morbidity and mortality around the world. A cornerstone of management includes prompt diagnosis and appropriate treatment of culprit pathogens. Timely diagnosis can improve patient care, assist in infection control, and prevent disease outbreaks. Historical methods of diagnosis include traditional culture methods and stool analysis. These are limited by long turnaround time and inability to simultaneously assess multiple pathogens. The advent of multiplexed nucleic acid amplification tests first began with the Food and Drug Administration-approved respiratory virus multiplex polymerase chain reaction (PCR) panel in 2009, followed by gastrointestinal infections in 2013, and neurological infections in 2014. We conducted a review of current literature pertaining to the clinical utility of a gastrointestinal multiplex PCR in management of acute and chronic diarrhea in patients. To date, seven platforms approved by the US Food and Drug Administration are used in detection of various bacterial, viral, and parasitic causative organisms for diagnosis of gastrointestinal infections. The sensitivity and specificity of each assay vary depending on the tested organism. Interpretation of a positive result has to be tailored to the clinical context. Further studies are required to establish the utility of gastrointestinal multiplex PCR from a cost-based perspective, whether specific enteropathogens such as Clostridioides difficile are better assessed with toxin gene detection and whether new parameters such as cycle threshold values can improve clinical application of test results.

ImmunoDisk—A Fully Automated Bead-Based Immunoassay Cartridge with All Reagents Pre-Stored

“…This may prospectively pave the way for the more general implementation of the BFPD-IA on other NAAT devices, thereby expanding their portfolio and achieving complementary diagnostics where, for example, pathogen identification and immunological response are tested on the same instrument, with major impacts on the health economics of diagnostics. Moreover, the health systems in several areas of medicine that require such co-assessment and interoperability between microbiological and immunological outcomes [ 50 , 73 , 77 , 78 , 79 , 80 ] would benefit from such complementary diagnostics.…”

BD MAX Enteric Bacterial, Bacterial Plus, and Virus Panels for Diagnosis of Acute Infectious Gastroenteritis: a Cost-Benefit Analysis

“…Likewise, implementing the BioFire FilmArray gastrointestinal panel, also in apparently mixed cohorts, was associated with reduced use of endoscopy, abdominal radiology and antibiotic prescribing in two other studies ( 9 , 10 ), although the precise extent of the saving was not provided. Nonetheless, as previously indicated ( 11 , 12 , 20 ), there are limited data available on the cost-effectiveness of implementing multiplex GI panels for the diagnosis of community-acquired AGE, thus excluding those due to Clostridioides difficile .…”

“…A total of 24 clusters were generated for each study period using a stratified sampling method, which combined the following clinical and demographic variables of the study population: pediatric versus adult versus elderly, hospital versus primary health care, immunosuppressed versus immunocompetent, and positive versus negative microbiological result. To avoid potential inaccuracies due to underrepresented clusters, the sample size in each cluster was estimated by the probability proportional to size (PPS) approach (30 to 70%) as previously recommended ( 12 , 24 , 25 ), in which 30% of the sample size in each cluster was common to all clusters, and 70% proportional to the size of each cluster in the original population. In each cluster, patients were randomly selected in both periods (2017 and 2018) by assigning random numbers using R software (R-Project; R Foundation for Statistical Computing, Vienna, Austria [ http://www.R-project.org ]).…”

“…Previous studies have shown reductions in time to empirical antibiotic therapy initiation, length of hospital stay, and isolation and improvement in the prescription of targeted antibiotic therapy when using multiplex PCR panels for the diagnosis of nosocomial or combined community- and hospital-acquired AGE ( 6 – 10 ). However, recent systematic reviews and a meta-analysis addressing this issue were not conclusive regarding the cost-effectiveness of this diagnostic strategy for either community-acquired or nosocomial AGE ( 11 , 12 ). To shed light on this issue, we evaluated the cost-benefit ratio, from a health care system perspective, of implementing BD MAX enteric PCR panels (BD Diagnostics, Sparks, MD) for diagnosis of community-acquired AGE in either hospitalized or nonhospitalized children and adults.…”

Phenotypic and genotypic characterization of salmonella Enteritidis isolated from two consecutive Food‐Poisoning outbreaks in Sichuan, China

“…To screen for enteroviruses and other common gastrointestinal pathogens, two stool samples randomly selected from each outbreak were analyzed using the FilmArray GI PCR panel (BioFire Diagnostics, Salt F I G U R E 1 Timeline of the two consecutive food-poisoning outbreaks. h, hours; Min, minimum; Max, maximum Lake City, USA) (Teh et al, 2021). Food and environmental samples, such as retained food, environmental samples from food processing sites, and environmental samples from the living areas of patients were tested for Salmonella, Shigella, and Staphylococcus aureus, following National Food Safety Standards of China (GB 4789.2-2016, GB 4789.10-2016, GB 4789.5-2012.…”