RealTime CT/NG
Description
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.
Abbott RealTime CT/NG Performance
| Technology | Multiplex, homogenous real-time PCR | |
| Sensitivity | 320 plasmid copies per 400 ìl sample | |
| 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 |
Abbott RealTime CT/NG Comparison Study to Comparator Assay
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) | Ratioa | (%) | 95% Cl | Ratiob | (%) | 95% Cl |
| CT | 621c | 116/127 | 91.3 | (85.03, 95.60) | 488/494 | 98.9 | (97.38, 99.55) |
| NG | 617d | 91/93 | 97.8 | (92.45, 99.74) | 518/524 | 98.9 | (97.52, 99.58) |
Design
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:
- Primer and Probe Design
- Sample Purification
- Incorporation of an Internal Control
Order Information
| Product Name | Package Size | Vysis® Order Number | Abbott Order Number |
| RealTime CT/NG Abbott RealTime CT/NG Amplification Reagent Kit | 192 tests (4 packs of 48 tests per pack) | 02G28-91 | 02G28-91 |
| RealTime CT/NG Abbott RealTime CT/NG Control Kit | 8 CT/NG Negative Control, 16 CT/NG Cutoff Control | 02G28-80 | 02G28-80 |
| RealTime CT/NG Abbott RealTime CT/NG Application CD-ROM | 1 each | 01L70 | 01L70 |
| RealTime CT/NG Abbott multi-Collect Specimen Collection Kit | 500 kits (10 boxes of 50 kits per box) | 09K12-01 | 09K12-01 |
