Evaluation of the BD Max Enteric Parasite Panel for Clinical Diagnostics

Abstract

We compared the performance of the BD Max enteric parasite panel to routine microscopy and an in-house PCR for the detection of Giardia intestinalis, Entamoeba histolytica, and Cryptosporidium spp. The enteric parasite panel showed good specificity for all targets and good sensitivity for E. histolytica and Cryptosporidium spp. Sensitivity for G. intestinalis with the BD Max enteric parasite panel was equivalent to that with microscopy. The World Health Organization (WHO) ranks diarrheal disease the second most common cause of morbidity and mortality in children and in the developing world (1, 2). The major etiological agents of parasitic diarrhea are considered to be Giardia intestinalis, Cryptosporidium spp., and Entamoeba histolytica (3-5).The detection of intestinal parasites can be improved, compared to microscopy, by the use of PCR-based methods (6-8). Recently, the BD Max enteric parasite panel (BD Diagnostics, Sparks, MD) was launched on the BD Max system (BD). The panel uses integrated DNA extraction and PCR to detect G. intestinalis, E. histolytica, and Cryptosporidium spp. (C. hominis and C. parvum). This study evaluated the enteric parasite panel on clinical samples and compared the performance to that of microscopy and an in-house PCR method.A total of 132 clinical samples were used for the evaluation. Overall, 39% of the samples had been stored frozen before the analyses on the BD Max system. Sixty-six samples (27 positive and 39 negative) were previously analyzed with a modified multiplexed in-house PCR for the presence of G. intestinalis, E. histolytica (9), and Cryptosporidium spp. (10) at the Department of Clinical Microbiology, Halland County Hospital, Halmstad, Sweden. Briefly, the in-house method included a prepreparation step by adding feces to lysis buffer, kept at Ϫ20°C overnight, followed by DNA extraction with a QIAsymphony DSP virus/pathogen kit (Qiagen GmbH, Germany) and a multiplex PCR run on RotorGene Q (Qiagen).The remaining samples (n ϭ 66) had previously been examined with microscopy for ova and cysts on concentrated fecal samples (32 positive and 34 negative) at the Department of Clinical Bacteriology, Sahlgrenska University Hospital, Gothenburg, Sweden. The samples analyzed with microscopy were all preserved in SAF transport medium (12.6 g/liter sodium acetate, 2% acetic acid, 4% formaldehyde, and 0.1% Triton X-100).A loop of 10 l of the fecal sample was added to the sample buffer tube (BD). The tube was vortexed and pretreated for 50 minutes on the BD prewarm heater prior to loading into the BD Max instrument along with the BD Max enteric parasite panel reagent strip. DNA extraction and real-time PCR were automatically performed by the instrument. Time from the start of sample preparation to the result, including automated data analysis, was ϳ3.5 h. The results were reported as negative or positive by the instrument. In the case of discordant results, the original sample was analyzed at a third laboratory (Ryhov County Hospital, Jönköping, Sweden) using an in-house PCR modifie...

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

“…The multiplex PCR assay Allplex TM GIPPA showed excellent performances for protozoa detection, even higher than that of other marketed PCR assays such as the BD Max TM Enteric Parasite Panel, G-DiaPara TM , or ParaGENIE G-Amoeba assays [9][10][11][12] and with additional targets. Indeed, the sensitivity of these assays ranged from 41% to 96% for G. duodenalis [9][10][11], depending on the extraction method and the assay, and the ParaGENIE G-Amoeba assay had 67% sensitivity for E. histolytica detection [12]. Moreover, the BD Max TM and G-DiaPara TM assays detected only C. parvum/hominis, and none of these detected C. cayetanensis, D. fragilis, or B. hominis.…”

Multicenter Evaluation of BD Max Enteric Parasite Real-Time PCR Assay for Detection of Giardia duodenalis, Cryptosporidium hominis, Cryptosporidium parvum, and Entamoeba histolytica

“…A recent study (23) compared the BD Max EPP to microscopy and to a lab-developed PCR assay for a small set of clinical samples. The sensitivity for G.…”

The GenMark ePlex ® : Another Weapon in the Syndromic Arsenal for Infection Diagnosis

“…With GenMark, for instance, pathogen detection involves ferrocene-labeled oligonucleotide probes, which associate with electrodes via amplicon-probe annealing events, altering impedance in a measurable way (as detailed below). Other major manufactures offering syndromic panels include: the FilmArray by BioFire (parent company bioMerieux), which utilizes nested PCR in sequential microreservoirs, with downstream fluorescence-detection on a 2D grid [11,13,17,18,25,26]; the VERIGENE by Luminex, which detects amplicons through gold/silver-conjugated oligonucleotide probes and an evanescent field phenomenon [17,18,26]; the xTAG and NxTAG flow cytometry systems, also by Luminex, which employ fluorescently barcoded microbeads to target amplicons [12,26,27]; the BD MAX system by BD, a qPCR platform that enables multiplexing through automated robotics [28,29]; and the T2Dx platform by T2 Biosystems, which utilizes NMR relaxometery to detect amplicon-mediated agglomeration of capture probes [19,21]. Additional technical details and performance characteristics of these platforms are detailed in the respective citations.…”