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CE Marked
For In Vitro Diagnostic Use
The Abbott RealTime CT/NG assay provides detection of Chlamydia trachomatis and Neisseria gonorrhoeae with proven clinical performance in sexually transmitted disease testing.
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.
The Abbott multi-Collect Specimen Collection Kit for use with CT/NG is available with pierceable caps.
Abbott RealTime CT Comparison Study to Comparator Assay1
A total of 623 specimens including female endocervical and vaginal swabs, male urethral swabs, and male and female urines were obtained from patients attending STD clinics. The swab specimens were always collected first with the comparator assay collection kit and then with the Abbott multi-Collect Specimen Collection Kit.
POSITIVE AGREEMENT | NEGATIVE AGREEMENT | ||||||
Analyte | Specimens (n) | Ratio | (%) | 95% Cl | Ratio | (%) | 95% Cl |
CT | 621 | 116/ 127 |
91.3 | (85.03, 95.60) | 488/ 494 |
98.9 | (97.28, 99.55) |
NG | 617 | 91/ 93 |
97.8 | (92.45, 99.74) | 518/ 524 |
98.9 | (97.52, 99.58) |
References
1. Abbott RealTime CT/NG[package insert]. Des Plaines, IL: Abbott Molecular; 2007.
Development Philosophy
Today's clinical molecular diagnostics laboratory must have confidence in the quality of their C. trachomatis and N. gonorrhoeae patient results. As a result of our real-time PCR development philosophy, Abbott RealTime CT/NG is engineered to be both sensitive and specific for the detection of C. trachomatis and N. gonorrhoeae from a single sample.
Accurate detection of CT or NG is dependent upon a combination of:
Abbott RealTime CT/NG Performance | |
Technology | Multiplex, homogenous real-time PCR |
Sensitivity | Limit of Detection is 320 plasmid copies of CT target and NG target DNA per assay |
Specificity | No cross-reactivity with 111 organisms |
Interference | No interference with 26 substances |
Internal Control | Added to lysis buffer during extraction and detected with all samples |
Collection Device | Abbott multi-Collect Specimen Collection Kit |
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