Abstract
Rapid diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae are desirable so that patients can be treated while they are still in the clinic or doctor's office. The Cepheid GeneXpert® (Xpert) CT/NG assay was US FDA-cleared in December 2012. The assay is a rapid real-time PCR nucleic acid amplified test. The cartridge-based assay detects DNA of Chlamydia trachomatis and Neisseria gonorrhoeae. It is FDA-cleared for use in female endocervical swabs, patient-collected vaginal swabs and for female and male urine specimens from symptomatic and asymptomatic patients. It has demonstrated near-perfect sensitivity and specificity in urogenital specimens. The Xpert is a modular platform for testing samples directly from patients, which requires no hands-on manipulation from specimen loading until results are available. Results are provided in approximately 90 minutes. It has been graded by the FDA as moderately complex for Clinical Laboratory Improvement Amendments. Several publications have reported its promising use in clinical settings.
Original language | English (US) |
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Pages (from-to) | 135-137 |
Number of pages | 3 |
Journal | Expert Review of Molecular Diagnostics |
Volume | 14 |
Issue number | 2 |
DOIs | |
State | Published - Mar 2014 |
Keywords
- Cepheid GeneXpert
- Chlamydia trachomatis
- Neisseria gonorrhoeae
- ocular samples
- point of care
- rapid real-time PCR
- rectal samples
ASJC Scopus subject areas
- Pathology and Forensic Medicine
- Molecular Medicine
- Molecular Biology
- Genetics