| Reference notes: |
| 1. This test qualitatively detects Neisseria gonorrhoeae (NG) DNA by RT-PCR cervical, urethral and extragenital sites (e.g. pharynx and rectum) swabs and first part urine specimens |
| 2. NG is a prevalent sexually transmitted infection (STI) that causes urogenital tract and extragenital sites infections. Individuals may initially be asymptomatic. |
| 3. A "Detected" result indicates NG-DNA was detected. |
| 4. An "Indeterminate" or "Inhibitor present" test result may be due to interfering substances such as inhibitors. Suggest repeat testing if clinically indicated. |
| 5. A "Not detected" test result indicates NG-DNA was not detected. False-negative results may be due to improper specimen collection, concurrent antibiotic therapy, or low numbers of organisms in the specimen (i.e., below the test's sensitivity). Suggest repeat testing if clinically indicated. |
| 6. The limit of detection for NG-DNA RT PCR assays is less than 25 copies/mL. Studies have shown that the specificity is about 92.8 - 99.9%. |
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| Sources: |
| 1. Tianlong Neisseria gonorrhoeae Nucleic Acid Detection Kit Insert |
| 2. Cepheid Xpert CT/NG Assay Kit Insert |