Neisseria Gonorrhoae - Detection by Real time PCR

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Detects gonorrhea infection.

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Neisseria Gonorrhoeae - Detection by Real Time PCR

Why is it done?
- Test Purpose: Detects the presence of Neisseria gonorrhoeae DNA using highly sensitive real-time polymerase chain reaction (PCR) technology to diagnose gonorrheal infection
- Primary Indications: Diagnosis of symptomatic or asymptomatic gonorrheal infection in urethral, endocervical, rectal, pharyngeal, and conjunctival specimens
- Clinical Reasons for Testing: Sexual partners of confirmed gonorrhea cases, sexually transmitted infection (STI) screening, urogenital symptoms (dysuria, discharge, pelvic pain), post-exposure prophylaxis follow-up, surveillance programs, and routine STI screening in sexually active individuals
- Specimen Types: First-void urine (preferred non-invasive specimen), urethral swabs, endocervical swabs, rectal swabs, pharyngeal swabs, and conjunctival swabs depending on site of infection
- Timing of Testing: Performed immediately when gonorrhea infection is suspected, during initial STI screening, within 14 days of potential exposure, and in certain cases 3-7 days post-treatment to confirm cure
Normal Range
- Normal Result: Negative or Not Detected - indicates absence of Neisseria gonorrhoeae DNA in the specimen
- Abnormal Result: Positive or Detected - indicates presence of Neisseria gonorrhoeae DNA confirming active infection
- Unit of Measurement: Qualitative result (Positive/Negative/Not Detected). Some laboratories may report as cycle threshold (Ct) value where lower Ct indicates higher bacterial load; typically Ct < 40 is considered positive
- Reference Range Interpretation: Negative/Not Detected is the normal range and indicates no gonorrheal infection. Positive result is abnormal and indicates active Neisseria gonorrhoeae infection requiring treatment. Borderline or indeterminate results should be repeated or clarified with laboratory director
- Test Sensitivity and Specificity: Real-time PCR offers >95% sensitivity and >99% specificity, making it one of the most accurate diagnostic methods available for gonorrhea detection
Interpretation
- Positive Result Interpretation: Confirms active Neisseria gonorrhoeae infection at the specimen collection site. Patient requires antimicrobial treatment typically with ceftriaxone and azithromycin or alternative regimens per current guidelines. Sexual partners require testing and treatment. Indicates need for additional STI testing (chlamydia, syphilis, HIV, etc.)
- Negative Result Interpretation: No Neisseria gonorrhoeae detected in the submitted specimen. Indicates either absence of infection or infection below the detection limit. Patient may have symptoms from other causes. Repeat testing may be warranted if clinical suspicion remains high and specimen quality was questionable
- Factors Affecting Results: Specimen quality and proper collection technique, timing of specimen collection during infection, site of specimen collection (urine less sensitive than urethral/cervical swabs), presence of menstrual blood, contamination, improper storage or transport, concurrent urinary tract infections, antibiotic therapy, and specimen volume
- Clinical Significance - Positive: Immediate treatment initiation is required to prevent complications including pelvic inflammatory disease, prostatitis, epididymitis, urethral strictures, infertility, ectopic pregnancy, and disseminated gonococcal infection. Prevention of transmission to sexual partners and prevention of vertical transmission in pregnant women are critical
- Clinical Significance - Negative: Low probability of active gonorrheal infection. If symptoms persist, consider other etiologies, repeat testing at appropriate intervals, ensure all sites have been tested (throat, rectum, genital sites), and continue monitoring for symptom development
- Multiple Site Testing: Recommend testing multiple anatomical sites (urethra/cervix, rectum, pharynx) simultaneously as infection may be localized to specific sites only, affecting sensitivity of single-site testing
Associated Organs
- Primary Organ Systems: Genitourinary system (urethra, prostate, epididymis in males; urethra, endocervix, uterus, fallopian tubes in females), rectum, pharynx, and conjunctiva
- Diseases and Conditions Associated with Positive Results: Acute urethritis, cervicitis, proctitis, pharyngitis, conjunctivitis (ophthalmia neonatorum in newborns), pelvic inflammatory disease (PID), prostatitis, epididymitis, orchitis, perihepatitis (Fitz-Hugh-Curtis syndrome), and disseminated gonococcal infection (DGI)
- Acute Complications: Urinary retention and dysuria in males, acute lower abdominal pain and abnormal vaginal discharge in females, rectal pain and bleeding, pharyngeal pain and exudate, conjunctival inflammation and purulent discharge, bacteremia with fever and arthralgia
- Chronic/Long-term Complications: Urethral strictures (males), chronic pelvic pain, infertility from tubal scarring (females), ectopic pregnancy, chronic prostatitis, recurrent infections, and increased susceptibility to other STIs including HIV
- Pregnancy-Related Risks: Increased risk of spontaneous abortion, premature rupture of membranes, preterm delivery, low birth weight, post-partum infection, and vertical transmission to neonates causing ophthalmia neonatorum and potential blindness if untreated
- Disseminated Gonococcal Infection: Rare but serious complication affecting joints (arthritis, arthralgia), heart (myocarditis, endocarditis), meninges (meningitis), and skin (characteristic pustular rash), requiring hospitalization and aggressive treatment
Follow-up Tests
- Initial Additional Testing (Recommended Concurrently): Neisseria gonorrhoeae nucleic acid amplification test (NAAT) from all potentially infected sites (urogenital, rectal, pharyngeal), Chlamydia trachomatis NAAT from same sites, syphilis serology (RPR/VDRL and FTA-ABS or TP-PA), HIV antigen/antibody testing, hepatitis B and C serology if indicated
- Partner Notification Testing: All sexual contacts within 60 days should undergo testing using same real-time PCR assay for gonorrhea and concurrent chlamydia testing, regardless of symptom status
- Test of Cure (Post-Treatment): Repeat NAAT testing 3-7 days post-treatment completion (not within 24 hours to avoid false positives from dead organisms). Test of cure recommended for all patients, particularly those with pharyngeal, rectal infection, or persistent symptoms
- Antimicrobial Susceptibility Testing (Resistance Surveillance): Culture and susceptibility testing when indicated (treatment failure, pregnant patients, or surveillance programs). Real-time PCR cannot detect antibiotic resistance; culture required for this information
- Pregnancy-Related Follow-up: Pregnant women with positive results should undergo test of cure to confirm treatment success. Ophthalmia prevention (erythromycin ointment) in newborn eyes mandatory. Neonate may require testing if delivery complicated or suspicion of transmission
- Clinical Assessment and Complications: Pelvic ultrasound or MRI if pelvic inflammatory disease suspected, urinalysis if urinary retention or hematuria present, joint aspiration and synovial fluid analysis if disseminated infection suspected, blood cultures if fever and bacteremia suspected
- Repeat Screening Schedule: Sexually active individuals should be rescreened annually or at least once per year (CDC guidelines). Higher frequency screening recommended for those with multiple partners, inconsistent condom use, or previous STI history
Fasting Required?
- Fasting Requirement: NO - Fasting is not required for this test
- Patient Preparation Instructions: For urine specimens: Patient should not urinate for at least 1-2 hours prior to providing first-void urine specimen (provides highest concentration of organisms). For urethral swabs: 1-2 hours of no urination prior to collection. For endocervical swabs: No douching or intravaginal products for 24 hours prior to collection. For rectal swabs: No bowel preparation needed. For pharyngeal swabs: No eating, drinking, or smoking for 15-30 minutes prior to collection
- Medications and Substances to Avoid: Recent antibiotic therapy within 24-48 hours may reduce positivity rate (specimens may yield false negatives). Intravaginal antimicrobial products, feminine hygiene products, lubricants, or spermicides 24 hours prior to collection. Urinary antiseptics should be avoided. Menstrual products should be avoided on collection day when possible
- Specimen Collection Important Details: Use laboratory-provided collection containers with appropriate preservative if required. For urine: Collect entire first void or first 20-30 mL in provided container. For swabs: Use only approved collection swabs (calcium alginate, dacron, or nylon). Do not use cotton swabs with wooden shafts. Place swabs immediately in appropriate transport medium. Specimens must be transported to laboratory within 24 hours (maintain at room temperature unless specified otherwise)
- Special Considerations: Patients should inform healthcare provider of recent antibiotic use, urinary tract symptoms, or concurrent infections. Pregnant patients should notify provider prior to testing. Patients should not attempt to self-collect pharyngeal or rectal specimens (proper technique by trained personnel essential). Informed consent and counseling on STI transmission should occur prior to testing

How our test process works!