CT/NG real-time PCR

Intended Use

To qualitatively detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA simultaneously in human clinical specimens using real-time PCR.

Specimen Required

Urogenital swabs – cervical, urethral; Urine samples.

Patient Preparation

Sample Collection: Collect specimens using sterile techniques to avoid contamination.
Specimen Preparation:
- Swab: Place immediately into appropriate transport medium if required.
- Urine: Collect in a clean, nonmetal container without preservatives if the specimen is maintained refrigerated or on ice during collection and transport to the laboratory.

Storage/Transport Temperature: Refrigerated
Unacceptable Conditions: Specimens in swab transport media without a swab; Under- or over-filled tubes of Urine container.
Remarks: Proper aseptic technique and sample handling are critical to avoid contamination or degradation.
Stability:
- Swab: Ambient: 2 months; Refrigerated: 2 months; Frozen: 1 year
- Urine: Ambient: 90 days; Refrigerated: 90 days; Frozen: Unacceptable.

Methodology

The test uses real-time PCR, multiplex format to amplify, detect, and identify the specific DNA sequences of CT and NG.

Sample Received to Report Turnaround Time (TAT)

Twice in a week (Scheduled Test)

Reference Interval

Positive or negative for presence of CT and/or NG DNA.

Interpretive Data

Refer to the Report.

Resources