Clinical evaluation of a non-purified direct molecular assay for the detection of Clostridioides difficile toxin genes in stool specimens

Abstract

Recently, a new rapid assay for the detection of tcdB gene of Clostridioides difficile was developed using the GENECUBE. The assay can directly detect the tcdB gene from stool samples without a purification in approximately 35 minutes with a few minutes of preparation process. We performed a prospective comparative study of the performance of the assay at eight institutions in Japan. Fresh residual stool samples (Bristol stool scale �5) were used and comparisons were performed with the BD MAX Cdiff assay and toxigenic cultures. For the evaluation of 383 stool samples compared with the BD MAX Cdiff assay, the sensitivity, and specificity of the two assays was 99.0% (379/383), 98.1% (52/53), 99.1% (327/330), respectively. In the comparison with toxigenic culture, the total, sensitivity, and specificity were 96.6% (370/383), 85.0% (51/60), and 98.8% (319/323), respectively. The current investigation indicated the GENECUBE Clostridioides difficile assay has equivalent performance with the BD MAX Cdiff assay for the detection of tcdB gene of C. difficile.

A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

“…The system automatically prepares reaction mixtures and amplifies and detects target genes in a short time and can analyze up to eight samples and four items at the same time in a single run. GENECUBE ® has been applied for several pathogens, including Mycobacterium tuberculosis [8], M. avium, M. intracellulare, Neisseria gonorrhoeae [9], Chlamydia trachomatis [9], Mycoplasma pneumoniae [7,10], Staphylococcus aureus (nuc and mecA) [11], and the toxin gene of Clostridioides difficile [12].…”

A prospective evaluation of the analytical performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

“…The system automatically prepares reaction mixtures and amplifies and detects target genes in a short time, which, in a single run, can analyze up to eight samples and four items at the same time. GENECUBE ® has been applied for several pathogens, including Mycobacterium tuberculosis [8], M. avium, M. intracellulare, Neisseria gonorrhoeae [9], Chlamydia trachomatis [9], Mycoplasma pneumoniae [7,10], Staphylococcus aureus (nuc and mecA) [11] and the toxin gene of Clostridiodes difficile [12].…”

The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol

“…GENECUBE 1 (TOYOBO Co., Ltd., Osaka, Japan) is a Qprobe-PCR-based automated rapid molecular identification system that can detect target genes in a short time and simultaneously analyze up to 12 samples and 4 assays in a single examination [4][5][6][7][8][9]. The system automatically performs molecular examination directly, including preparation of the reaction mixtures, and amplification and detection of target genes, in 30 minutes.…”