Neisseria Gonorrhoeae by PCR

This test is performed via the Abbott Alinity m STI assay. The qualitative detection of DNA from Neisseria gonorrhoeae (NG) is performed via polymerase chain reaction (PCR) to aid in the diagnosis of sexually transmitted infections.

NGPCR

NG, gonorrhoeae, sexually transmitted infection

• Urine or swabs from the cervix, vagina, rectum, or throat collected in the Alinity m multi-collect kit. 
• Gynecological specimen (pap smear) collected in ThinPrep PreservCyt solution.

For urine specimens: Using the pipette provided in the kit, add enough urine to the collection device so the fill volume is between the min/max window.

Neat urine. Pap smear specimen collected in ThinPrep PreservCyt solution.

Document the physiological source of sample in the ordering EMR. Do not cover the fill window with patient label. Do not transfer pap smear specimens into the Alinity m multi-collect transport tube.

Alinity m multi-collect transport tube

Room temperature

15-30C up to 14 days

Samples collected in any kit other than Alinity m multi-collect kit. Collection kit with more than 1 swab. Swabs from any non-approved physiological site. Vaginal swabs collected outside of a clinician's office.

M, T, W, Th, F, Sat, Sun

24 hours after specimen receipt

The Alinity m STI Assay target of N. gonorrhoeae has been validated for male and female urine, ThinPrep specimens, and swabs from the cervix, vagina, rectum, or throat only. Performance or validity has not been established for other sample sources.
 
False negative results of Not Detected can be observed in the presence of the following interfering substances: mucus, seminal fluid, γ-globulin, glucose, feces, and certain hemorrhoidal creams or toothpaste brands.
 
This assay has not been evaluated with patients who are currently being treated with antimicrobial agents active against CT, NG, TV, and MG and should not be used to determine therapeutic success or failure as nucleic acids may persist after appropriate antimicrobial therapy.

Use of the Alinity m STI Assay is not approved for patients younger than 14 years of age, for the evaluation of suspected sexual abuse contact tracings, nor for other medico-legal indications. Additional testing is recommended in any circumstance when false positive or false negative results could lead to adverse medical, social, or psychological consequences.

Not Detected

Neisseria gonorrhoeae (NG) is the causative agent of gonorrhea, the most common STI in the United States. In men, gonorrhea usually results in acute anterior urethritis, accompanied by a purulent exudate. In women, the infection is most often found in the cervix, but the vagina and uterus may also be infected. Gonorrhea is frequently asymptomatic, especially in women. Without treatment, local complications can occur including PID, acute salpingitis, or epididymitis. NG can infect the rectum and oropharynx of both men and women. Rectal infection may result in discharge, itching, soreness, bleeding, or cause painful bowel movements. Oropharyngeal infections can cause a sore throat. Infections in both of these sites are often asymptomatic and can serve as a reservoir for future infection.