Comparative Evaluation of Seegene Allplex Gastrointestinal, Luminex xTAG Gastrointestinal Pathogen Panel, and BD MAX Enteric Assays for Detection of Gastrointestinal Pathogens in Clinical Stool Specimens

Abstract

Context.— Infectious gastroenteritis is caused by various pathogens, including bacteria, viruses, and parasites. Objective.— To compare the performance of Seegene Allplex Gastrointestinal (24 targets: 13 bacteria, 5 viruses, and 6 parasites in 4 panels), Luminex xTAG Gastrointestinal Pathogen Panel (15 targets: 9 bacteria, 3 viruses, and 3 parasites), and BD MAX Enteric panel (5 bacteria and 3 parasites). We estimated the agreement among 3 molecular assays. Design.— A total of 858 stool samples (554 bacterial/parasite and 304 viral pathogens) were included. A consensus positive/negative was defined as concordant results from at least 2 tests. To evaluate the agreement among the assays, κ value was calculated. Results.— The overall positive percentage agreements of Seegene, Luminex, and BD MAX were 94% (258 of 275), 92% (254 of 275), and 78% (46 of 59), respectfully. For Salmonella, Luminex showed low negative percentage agreement because of frequent false positives (n = 31) showing low median fluorescent intensity. For viruses, positive/negative percentage agreements of Seegene and Luminex were 99%/96% and 93%/99%, respectively. Compared with routine microbiology testing, Seegene, Luminex, and BD MAX additionally identified 39, 40, and 12 pathogens, respectively. Sixty-one cases (16 cases with Seegene, 51 cases with Luminex, and 1 case with BD MAX) showed positive results for multiple pathogens, but only 3 were consensus positive. Conclusions.— These multiplex molecular assays appear to be promising tools for the detection and identification of multiple gastrointestinal pathogens simultaneously. However, careful interpretation of positive results for multiple pathogens is required.

Evaluation of the AllplexTM Gastrointestinal Panel—Parasite Assay for Protozoa Detection in Stool Samples: A Retrospective and Prospective Study

“…Among them, one included a unique stool positive for parasites (Cryptosporidium spp.) which was detected by the assay [13]. Another study, with a more consistent cohort, observed performances slightly lower to ours, with 92%, 100%, and 78% sensitivity for G. duodenalis, E. histolytica \, and Cryptosporidium spp., respectively [14].…”

Evaluation of a laboratory-developed test for simultaneous detection of norovirus and rotavirus by real-time RT-PCR on the Panther Fusion® system

“…The multiplex LDT showed a very good sensitivity and specificity. The LDT was at least as sensitive in the detection of both viruses as a CE-cleared reference assay, which claims to have a limit of detection (LoD) of 75 tissue-culture infectious dose 50 (TCID 50 ) units per milliliter sample for norovirus G1, 5 TCID 50 /ml for norovirus G2, and 50 RNA copies per reaction for rotavirus according to the manufacturer (user manual Allplex™ GI-virus assay 05/2017 V2.0), and that has demonstrated excellent agreement with other molecular assays for stool pathogen diagnostics [17].…”

How to Interpret a Positive Campylobacter PCR Result Using the BD MAXTM System in the Absence of Positive Culture?

“…The BD MAX TM Enteric Bacterial Panel PCR clearly improves the diagnosis of Campylobacter sp. infections by enabling the laboratories to deliver fast and targeted results to their clinicians [6,7]. Syndromic approaches now replace the traditional research by culture.…”