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RealTime CT/NG

For In Vitro Diagnostic Use

The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals:clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.

CT/NG PCR Assay Virus

Abbott RealTime CT/NG Performance
Technology Multiplex, homogenous real-time PCR
Sensitivity 320 plasmid copies of CT target DNA 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

The Abbott multi-Collect Specimen Collection Kit for use with CT/NG, is now 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


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

The Abbott RealTime CT/NG assay is designed with dual cryptic plasmid targets allowing for the detection of wild type (wtCT) and new variant Chlamydia trachomatis (nvCT). In addition to its chromosomal DNA, C. trachomatis harbors a cryptic plasmid, which is found in all serovars at approximately 7 to 10 copies per organism. The NG PCR primers target a region of the Opa gene of N. gonorrhoeae.

Single Stranded Linear Probe Design

Single Stranded Linear Probe Design

The Abbott RealTime CT reagent contains two sets of CT PCR primers that target two different regions of the plasmid. Both primer sets target short sequences that are highly conserved among all serovars of C. trachomatis but are not found in other species.

 

Intended Use

The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.



Limitations of the Procedure

FOR IN VITRO DIAGNOSTIC USE ONLY.

• Optimal performance of this test requires appropriate specimen collection, handling, and storage. The assay should be performed only on swab samples from the vagina, the endocervix, the male urethra, or on urine from males and females.The use of specimens other than those listed has not been validated.

• Use of the Abbott RealTime CT/NG assay is limited to personnel who have been trained on the use of the m2000sp and m2000rt.

• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the controls, specimens, and amplification product must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.

• A negative result does not exclude the possibility of infection because results are dependent on appropriate specimen collection and absence of inhibitors. The presence of PCR inhibitors may cause invalid results with this product.

• The Abbott RealTime CT/NG assay will not detect plasmid-free variants of C. trachomatis.

• Therapeutic success or failure should not be determined as analyte nucleic acids may persist after appropriate antimicrobial therapy.

• The Abbott RealTime CT/NG assay for male and female urine testing must be performed on first-catch urine specimens (defined as the first 20-30 mL of the urine stream). The effects of other variables such as first-catch vs. mid-stream, post douching, etc. have not been determined.

• The presence of blood, mucus, some spermicidal agents, feminine powder sprays, and treatments for vaginal conditions such as yeast infection may interfere with nucleic acid test based assays. The effects of other factors such as vaginal discharge, use of tampons, douching, or specimen collection variables have not been determined.

• The Abbott RealTime CT/NG assay is not intended to replace culture and other methods(e.g., cervical exam) for diagnosis of urogenital infection. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.

• Use of the Abbott RealTime CT/NG assay is not approved for the evaluation of suspected sexual abuse contact tracings nor for other medico-legal indications.

• As with any diagnostic test, results from the Abbott RealTime CT/NG assay should be interpreted in conjunction with other clinical and laboratory findings.

• The Abbott RealTime CT/NG assay has not been validated for use with vaginal swab specimens collected by patients at home.

• The patient-collected vaginal swab specimen application is limited to health care facilities where support/counseling is available to explain the procedures and precautions.

For In Vitro Diagnostic Use