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Test Code:
090-70-1020-02

Order Name:
C.trachomatis and N.gonorrhoeae by NAAT (Endocervical Swab)

 
Useful For:
Use for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in patient specimens.
 
Methodology:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Test List In Profile:
Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (NG)
 
AliasesName:
Chlamydia/Neisseria
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), PCR
C.trachomatis and N.gonorrhoeae by Nucleic Acid Amplification
CT/NG Nucleic Acid Amplification test
Gonorrhea
 
 
 
Test Code:
090-70-1020-02

Order Name:
C.trachomatis and N.gonorrhoeae by NAAT (Endocervical Swab)

 
Collection Specimen Or Container:
Endocervical Swab/cobas® PCR media
 
Specimen Testing Type:
Endocervical Swab
 
Sub Mission Container:
cobas® PCR media
 
Rejection Criteria:
Hemolysis: Mild OK; Gross reject
Other:
  1. Specimen appear bloody or have a dark brown color.
  2. Specimen tubes with no swabs or with two swabs.
 
Specimen Stabillity:
Specimen Type Temperature Time
Swab specimen collected in cobas® PCR Media 2oC to 30oC 12 months
 
 
 
Test Code:
090-70-1020-02

Order Name:
C.trachomatis and N.gonorrhoeae by NAAT (Endocervical Swab)

 
Method detail:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Schedule:
Monday, Wednesday and Friday, at 10:00 a.m.
 
Turnaround Time:
Received specimen to reported within 3 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
7 days
 
 
 
Test Code:
090-70-1020-02

Order Name:
C.trachomatis and N.gonorrhoeae by NAAT (Endocervical Swab)

 
 
Clinical Information:
Chlamydia trachomatis (CT) is the causative infectious agent for a variety of diseases in men: urethritis, proctitis, conjunctivitis, epididymitis and Reiter’s Syndrome. Among women, the consequences of chlamydial infections are severe if left untreated. Since approximately half of these infections are asymptomatic, many cases go undetected and untreated, leading to additional problems, particularly with pregnant women. In addition, re-infections are frequent if the sex partners are not treated. CT infection can cause urethritis, cervicitis, proctitis, conjunctivitis, endometritis, salpingitis (with subsequent infertility or ectopic pregnancy) and perihepatitis. Infants from infected mothers can develop conjunctivitis, pharyngitis and pneumonia.
Clinical manifestations of Neisseria gonorrhoeae (NG) infections are numerous. In men, acute urethritis presents itself after a 1-10 day incubation period with urethral discharge and dysuria. Only a small proportion of men remain asymptomatic without signs of urethritis. Acute epididymitis is the most common complication, especially in young men. In women, the primary site of infection is the endocervix. There is a high prevalence of co-infections with CT, Trichomonas vaginalis, and bacterial vaginosis; many women remain asymptomatic and therefore do not seek medical care. The predominant symptoms are increased discharge, dysuria, and intermenstrual bleeding. Pelvic inflammatory disease can occur in 10%-20% of women, combined with endometritis, salpingitis, tubo ovarian abscess, pelvic peritonitis, and perihepatitis. Other gonococcal infected sites are the rectum, pharynx, conjunctiva, and to a lesser degree the disease presents itself as disseminated gonococcal infection. Infants from infected mothers can develop conjunctivitis.
 
Reference Value:
Test Reference Value
Chlamydia trachomatis (CT) Negative
Negative Neisseria gonorrhoeae (NG) Negative
 
Interpretation:
  1. A positive result indicates that specimen is positive for the presence of Chlamydia trachomatis or Neisseria gonorrhoeae DNA and supports a diagnosis of chlamydial or gonorrheal infection.
  2. The presence of mucus in endocervical and cervical specimens may inhibit PCR and cause false negative test results. Mucus free specimens are required for optimal test performance. Use a sponge or an additional swab to remove cervical secretions and discharge before obtaining the specimen.
  3. A negative result does not preclude the presence of CT and/or NG infection because the detection of C. trachomatis and N. gonorrhoeae is dependent on the number of organisms present in the specimen and may be affected by specimen collection methods, patient factors (i.e., age, history of STD, presence of symptoms), stage of infection and/or infecting C. trachomatis and N. gonorrhoeae strains.
  4. Reliable results are dependent on adequate specimen collection, transport, storage and processing procedures.
  5. Though rare, mutations within the highly conserved regions of the cryptic plasmid or genomic DNA of C. trachomatis or the genomic DNA of N. gonorrhoeae covered by the test’s primers and/or probes may result in failure to detect the presence of the bacterium.
 
Clinical Reference:
Manufacturer’s package insert, cobas® 4800 CT/NG Test, March 2019, Roche Molecular Systems, NJ 08876 Branchburg, USA.