The Abbott RealTime CT/NG 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.

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

Indications and Limitations of Use

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

• 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.