RealTime CT/NG

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.

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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.

  • High sensitivity and specificity for dual detection of C. trachomatis and N. gonorrhoeae – Accurate results by avoiding cross reactivity with other organisms including non-STD Chlamydia and Neisseria species 
  • Unique Abbott multi-Collect Specimen Collection Kit for multiple sample types – Efficiency in clinical specimen collection and laboratory workflow
  • Pierceable caps with multi-Collect Specimen Collection Kit – Improves workflow by eliminating the need to uncap every specimen
Pierceable caps

The Abbott multi-Collect Specimen Collection Kit for use with CT/NG is available with pierceable caps.

  • Pierceable caps eliminate the need to uncap each tube 
    • Improving lab workflow
    • Minimizing cross contamination
    • Reducing potential for repetitive motion injuries
  • No swab transfer or manual expression of swabs
  • No sample centrifugation or vortexing
  • No manual pipetting or addition of lysis buffer

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.

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 (CT – dual probe with cryptic plasmid; NG –  single probe with opa gene)
  • Sample purification
  • Incorporation of an internal control

 

Specifications
 
 
 
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

Ordering Info

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