RealTime CT

CE Marked

For In Vitro Diagnostic Use

The Abbott RealTime CT assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens. 

icon-link.pngInstructions for Use View Ordering Information 
Description
 

The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in plasma or whole blood DNA levels.

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)

 
The Abbott multi-Collect Specimen Collection Kit for use with CT, is now available with pierceable caps!

Pierceable Caps

Pierceable caps eliminate the need to uncap each tube, which:

  • Improves lab workflow
  • Minimizes cross contamination
  • Reduces potential for repetitive motion injuries

Other benefits include:

  • No swab transfer or manual expression of swabs
  • No sample centrifugation or vortexing
  • No manual pipetting or addition of lysis buffer
Design
 

Development Philosophy

Today's clinical molecular diagnostics laboratory must have confidence in the quality of their C. trachomatis patient results. As a result of our real-time PCR development philosophy, Abbott RealTime CT is engineered to be both sensitive and specific for the detection of C. trachomatis from a single sample.

Accurate detection of CT is dependent upon a combination of:

  • Primer and probe design (dual probe with cryptic plasmid)
  • Sample purification
  • Incorporation of an internal control

Single Stranded Linear Probe

Abbott RealTime CT Target Design

 
Specifications
 
 
 
Abbott RealTime CT Performance
Technology Homogenous real-time PCR
Sensitivity 320 plasmid copies of CT 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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