Genexpert dx system

Manufactured by Cepheid

Sourced in United States

The GeneXpert Dx system is a fully-integrated, automated molecular testing platform designed for the detection of various infectious diseases. It combines sample preparation, nucleic acid amplification, and detection into a single, self-contained cartridge. The system provides rapid, accurate, and reliable results, enabling healthcare providers to make timely clinical decisions.

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Lab products found in correlation

Vitek 2 automated microbiology system, by bioMérieux (1 mentions) Vitek 2 automated system, by bioMérieux (1 mentions) Sars cov 2 elite mgb kit, by ELITechGroup (1 mentions) Cobas e411, by Roche (1 mentions) Xpert xpress cov 2 plus, by Cepheid (1 mentions) Alinity m, by Abbott (1 mentions) Alinity m sars cov 2 amp kit, by Cepheid (1 mentions) Liaison analyzer, by DiaSorin (1 mentions) Xpert sa nasal complete assay, by Cepheid (1 mentions) Vitek 2 compact, by bioMérieux (1 mentions) Vitek ms, by bioMérieux (1 mentions) Bact alert, by bioMérieux (1 mentions)

11 protocols using genexpert dx system

COVID-19 Diagnosis by GeneXpert System

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The sample was collected
according to the complete protocol of
the biosafety interim guideline. To confirm the sample was COVID-19
positive, the nasopharyngeal swab specimen was taken and placed in
3 mL of the normal saline medium. It was mixed by inverting it a minimum
of five times. The diluted specimen was then transferred to a SARS-CoV-2
Xpert cartridge through a sterile dropper and loaded into the GeneXpert
System platform (Rapidmicrobiology Xpert Xpress SARS-CoV-2 Point-of-Care
Test).^{62 ,63 (link)} The GeneXpert Dx System (Cepheid, Sunnyvale,
CA) is an automated sample-processing and real-time PCR component
with a completely closed cartridge, containing sample-processing and
lyophilized form of the real-time RT-PCR reagent. The machine consists
of modules, each for separate testing purposes, to avoid cross-contamination.
It has built-in auto-sample preparation, extraction, amplification,
and detection for target sequence detection. The Xpert SARS-CoV-2
test targets the E and N2 genes.^{64 (link)} The
system consists of a software-based auto-interpretation of results,^{65 (link)} which are automatically compared and analyzed
through auto built-in, pre-established software.

Khan M.T., Ali S., Khan A.S., Muhammad N., Khalil F., Ishfaq M., Irfan M., Al-Sehemi A.G., Muhammad S., Malik A., Khan T.A, & Wei D.Q. (2021). SARS-CoV-2 Genome from the Khyber Pakhtunkhwa Province of Pakistan. ACS Omega, 6(10), 6588-6599.

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Diagnosis of Clostridium difficile Infection

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Stool specimens were cultured to confirm the presence of toxigenic C. difficile. Before inoculation, each specimen was pre-treated using the alcohol-shock method, mixed with an equivalent volume of alcohol, and incubated for 30 min. Alcohol-shocked specimens were inoculated into C. difficile selective agar (BD Co., Franklin Lakes, NJ, USA) and incubated at 35°C for 48 h under anaerobic conditions. Colonies suspected of being C. difficile were identified using a VITEK 2 automated microbiology system (bioMérieux, Marcy l'Etoile, France). After isolating C. difficile, PCR was performed to determine the presence of C. difficile toxin genes (tcdA, tcdB, cdtA and cdtB) as previously described [23 (link)24 (link)]. The presence of the C. difficile toxin B gene in patient samples was examined by real-time PCR using the GeneXpert DX system (Cepheid, Sunnyvale, CA, USA).
The identification of enterococcal growth was performed using the VITEK 2 automated system (bioMérieux), and antibiotic susceptibility was determined using a VITEK 2 antibiotic susceptibility test card (bioMérieux).

Jeon Y.D., Ann H.W., Lee W.J., Kim J.H., Seong H., Kim J.H., Ahn J.Y., Jeong S.J., Ku N.S., Yeom J.S., Yong D., Lee K, & Choi J.Y. (2019). Characteristics of Faecal Microbiota in Korean Patients with Clostridioides difficile-associated Diarrhea. Infection & Chemotherapy, 51(4), 365-375.

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Evaluating SARS-CoV-2 Antigen and Molecular Tests

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Data of multiplex respiratory panel tests were integrated with SARS-CoV-2 test results assessed by antigenic or molecular tests. SARS-CoV-2 antigen testing was performed using the electrochemiluminescence immunoassay (ECLIA) Roche Elecsys SARS-CoV-2 Antigen on a Roche Cobas e411 (Roche Diagnostics GmbH, Mannheim, Germany) or the fluorescent immunoassay RADT STANDARD F COVID-19 Ag FIA on an F2400 analyzer (SD BIOSENSOR, Korea). According to the manufacturers’ instructions, a result of cut-off index (COI) ≥ 1.0 was interpreted as reactive for SARS-CoV-2 antigen. Molecular tests were performed for the detection of the SARS-CoV-2 virus through reverse transcription (RT), followed by real-time PCR from RNA extracted from respiratory samples by different assays according to the manufacturers’ instructions. The Cepheid Xpert Xpress CoV-2 plus performed on Cepheid’s GeneXpert^®DX system (Cepheid, Sunnyvale, CA, USA) is an assay that amplifies and detects unique sequences in the nucleocapsid (N), envelope (E), and RNA-dependent RNA polymerase (RdRP) genes of the SARS-CoV-2 genome. The SARS-CoV-2 ELITe MGB Kit^® (Elitechgroup, Turin, Italy), performed using the ELITe InGenius instrument (Elitechgroup, Turin, Italy), is an assay that amplifies and detects unique sequences in the RdRp and ORF8 genes of the SARS-CoV-2 genome.

Di Maio V.C., Scutari R., Forqué L., Colagrossi L., Coltella L., Ranno S., Linardos G., Gentile L., Galeno E., Vittucci A.C., Pisani M., Cristaldi S., Villani A., Raponi M., Bernaschi P., Russo C, & Perno C.F. (2024). Presence and Significance of Multiple Respiratory Viral Infections in Children Admitted to a Tertiary Pediatric Hospital in Italy. Viruses, 16(5), 750.

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Xpert MRSA/SA SSTI Assay

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The Cepheid Xpert MRSA/SA Skin and Soft Tissue Infection Assay (Xpert MRSA/SA SSTI Assay) performed in the GeneXpert^® Dx System, (Cepheid, Sunnyvale, CA, USA) is a qualitative in vitro diagnostic test intended for detection of S. aureus and MRSA from skin and soft tissue infection swabs.

Al-Humaidan O.S., El-Kersh T.A, & Al-Akeel R.A. (2015). Risk factors of nasal carriage of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus among health care staff in a teaching hospital in central Saudi Arabia. Saudi Medical Journal, 36(9), 1084-1090.

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Comparison of SARS-CoV-2 Detection Assays

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Nasopharyngeal (NP) swabs in transport media and plasma samples were held at 4°C (or −80°C if > 12 h) prior to testing on the Alinity M SARS CoV-2 Amp kit and/or Cepheid Xpert Xpress SARS-CoV-2 kit. The GeneXpert ®Dx System (Cepheid) and Alinity M (Abbott) performed automated specimen processing and real-time RT-PCR analysis. The Cepheid Xpert Xpress SARS-CoV-2 kit detects N and E genes of the SARS CoV-2 genome; Alinity M SARS CoV-2 Amp kit detects RdRp and N genes.

Sokal A., Chappert P., Barba-Spaeth G., Roeser A., Fourati S., Azzaoui I., Vandenberghe A., Fernandez I., Meola A., Bouvier-Alias M., Crickx E., Beldi-Ferchiou A., Hue S., Languille L., Michel M., Baloul S., Noizat-Pirenne F., Luka M., Mégret J., Ménager M., Pawlotsky J.M., Fillatreau S., Rey F.A., Weill J.C., Reynaud C.A, & Mahévas M. (2021). Maturation and persistence of the anti-SARS-CoV-2 memory B cell response. Cell, 184(5), 1201-1213.e14.

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Comparative Evaluation of C. difficile Detection Assays

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C. diff Chek-60 and toxin A/B II, a GDH and a toxin EIA respectively, were performed as described by the manufacturer (TechLab) on a Tecan Minilyser instrument (Tecan Group Ltd., Männedorf, Switzerland). The chemiluminescent immunoassays LIAISON C. difficile GDH and LIAISON C. difficile Toxins A&B (DiaSorin Inc, Stillwater, MN, USA) were performed according to the manufacturers’ recommendations on a LIAISON Analyzer (DiaSorin). The Cepheid Xpert C. difficile assay, which is a multiplex real-time PCR assay, was performed on the Cepheid GeneXpert Dx system following the manufacturers’ instructions.

Makristathis A., Zeller I., Mitteregger D., Kundi M, & Hirschl A.M. (2017). Comprehensive evaluation of chemiluminescent immunoassays for the laboratory diagnosis of Clostridium difficile infection. European Journal of Clinical Microbiology & Infectious Diseases, 36(7), 1253-1259.

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Screening Carbapenem-Resistant Enterobacterales

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Carbapenem-resistant Enterobacterales isolates were screened for common carbapenemases encoding genes with the Xpert Carba-R test in the Gene Xpert Dx System (Cepheid, Sunnyvale, CA, USA). Enterobacterales isolates, harbouring bla_NDM, were selected and tested further for the study.

Khan S., Das A., Vashisth D., Mishra A., Vidyarthi A.J., Gupta R., Begam N.N., Kataria B, & Bhatnagar S. (2024). Evaluation of a simple method for testing aztreonam and ceftazidime-avibactam synergy in New Delhi metallo-beta-lactamase producing Enterobacterales. PLOS ONE, 19(5), e0303753.

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Rapid COVID-19 Detection Using GeneXpert

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The GeneXpert Dx system (Cepheid) is an integrated diagnostic device that performs automated specimen processing and real-time RT-PCR analysis. The Xpert Xpress test consists of two main components: (i) the plastic cartridge, which contains liquid sample-processing and PCR buffers and lyophilized real-time RT-PCR reagents, and (ii) the GeneXpert Dx system, which controls intracartridge fluidics and performs real-time RT-PCR analysis. The EUA approved Xpert Xpress test was designed to amplify sequences of the envelope (E), nucleocapsid (N2), and RNA-dependent RNA polymerase genes. Only results from the E and N2 targets are used to generate test results. If both targets are detected, or if only N2 is detected, the test reports a positive result. If only the E target is detected the test reports a presumptive positive result because the target is shared among some members of the Sarbecovirus subgenus of coronaviruses. The EUA approved Xpert test allows the user to see amplification curves and Ct values for the N2 and E targets only.

Abasiyanik M.F., Flood B., Lin J., Ozcan S., Rouhani S.J., Pyzer A., Trujillo J., Zhen C., Wu P., Jumic S., Wang A., Gajewski T.F., Wang P., Hartley M., Ameti B., Niemiec R., Fernando M., Mishra V., Savage P., Aydogan B., Bethel C., Matushek S., Beavis K.G., Agrawal N., Segal J., Tay S, & Izumchenko E. (2021). Sensitive detection and quantification of SARS-CoV-2 in saliva. Scientific Reports, 11, 12425.

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Rapid Detection of Nasal S. aureus

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Nasal colonization with S. aureus (either MSSA or MRSA) was examined in clinical samples collected from the right and left nasal vestibule mucosa. The nasal swabs were taken within the 30 days prior to hospitalization and were processed using the Cepheid Xpert SA Nasal Complete assay (Cepheid, Sunnyvale, CA, USA), according to the manufacturer’s instructions on the GeneXpert Dx system (Cepheid). The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequence in simple samples using real-time PCR. The primers and probes in the Xpert SA Nasal Complete assay detect proprietary sequences of the staphylococcal protein A (spa) gene, the gene for methicillin/oxacillin resistance (mecA), and the staphylococcal cassette chromosome (SCCmec) inserted into the SA chromosomal attB site. The results were provided automatically by the GeneXpert Dx system and were positive for S. aureus if the spa gene was detected, and positive for MRSA if the spa, mecA, and SCCmec genes were all detected. The results of the test were available within less than 2 h after collection.

Szymankiewicz M., Jarzynka S., Koryszewska-Bagińska A, & Nowikiewicz T. (2023). The Impact of Nasal Staphylococcus aureus Carriage on Surgical-Site Infections after Immediate Breast Reconstruction: Risk Factors and Biofilm Formation Potential. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 29, e940898-1-e940898-11.

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Automated Cell Enrichment and HPV Detection

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Cell solution taken directly from the SurePath collection vials was homegenized and transferred to BD centrifuge tubes (c-tubes) containing pre-aliquoted density reagent, using the BD PrepMate Automated Accessory, according to the manufacturer’s instructions (Becton Dickinson). Two different centrifugation steps were then carried out to produce a concentrated and enriched cell pellet, as normally used for SlidePrep and cytological screening. In this study, 1 ml of enriched pellet suspension was placed in an Xpert HPV cartridge (Cepheid, Sunnyvale, CA, USA) and run and analysed on the GeneXpert Dx system for second-generation real-time PCR analysis, according to the manufacturer’s instructions, as in Rabaan et al. [15 (link)].

Rabaan A.A., Alfaraj S.A, & Alkhalifah M.A. (2018). Comparison of the Cepheid Xpert HPV test and the HC2 High-Risk HPV DNA Test for detection of high-risk HPV infection in cervical smear samples in SurePath preservative fluid. Journal of Medical Microbiology, 67(5), 676-680.

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