TABLE 3.
Nucleic acid detection tests (including DNA probe tests, direct probe and amplified probe detection)
Test | Description | Sensitivity/specificity* | |
---|---|---|---|
DNA probe test for culture confirmation | AccuProbe Neisseria gonorrhoeae culture confirmation test (Gen-Probe, USA) | Detection of species-specific ribosomal RNA (rRNA) sequences using a chemiluminescent acridinium ester-labelled, single-stranded gonococcal rRNA | 100% sensitive,100% specific (194 strains tested) (51) |
Detection of N gonorrhoeae directly from clinical specimens types (urine, endocervical swab [women], urethral swabs [men]; some kits can use vaginal swab) | |||
Direct probe | Gen-Probe PACE2 PACE2C (Gen-Probe, USA) | Detection of a specific sequence of Chlamydia trachomatis or N gonorrhoeae rRNA using a chemiluminescent acridinium ester-labelled DNA probe | 96.3% sensitive, 98.8% specific (33) |
Hybrid Capture II assay (Digene Corporation, USA) | RNA hybridization probes specific for genomic DNA and cryptic plasmid DNA sequences of C trachomatis and N gonorrhoeae | 93% sensitive (94 specimens tested) 98.5% specific 1263 specimens tested) (27) | |
Nucleic acid amplification tests | Roche AMPLICOR (Roche Diagnostic Systems, USA) | Detection of a 201 base pair sequence in the cytosine methyltransferase gene | 96% specific, 100% sensitive (618 samples) (52) |
Becton Dickinson BD ProbeTec (BD Biosciences, USA) | Detection of a DNA sequence in the multicopy pilin gene-inverting protein homologue | 100% sensitive and specific in a limited sampling of 57 specimens (27) | |
NucliSens Basic (Organon Teknika, The Netherlands) | Detection of 16S rRNA of N gonorrhoeae using RNA amplification | 97.9% sensitive, 98.7% specific (216 specimens tested) (32) | |
Abbott LCx (Abbott Laboratories, USA) No longer available in Canada | Detection of a 48 base pair sequence in the opa genes of N gonorrhoeae | 97.3% to 100% sensitive, 97.8% to 100% specific (8) |
Most studies use culture identification as the gold standard to establish the sensitivity and specificity values