TABLE 3. Chlamydia trachomatis and Neisseria gonorrhoeae Nucleic Acid Amplification Test (NAAT) target sequences and possible false reactions, by test type
|
FDA-cleared NAAT |
Nucleic acid target for C. trachomatis |
Nucleic acid target for N. gonorrhoeae |
|---|---|---|
|
Abbott RealTime CT/NG (Abbott Laboratories, Abbott Park, IL) |
Two distinct specific sequence regions within the 7,500 base pair C. trachomatis cryptic plasmid DNA. The test does not detect plasmid free C. trachomatis. No false-positive tests based on analytical specificity testing. |
48 base pair sequence within the Opa gene of N. gonorrhoeae. No false-positive tests based on analytical specificity testing. |
|
Aptima COMBO 2 assay Aptima CT assay Aptima GC assay (Hologic/Gen-Probe Inc., San Diego, CA) |
Specific region within the 23S rRNA from C. trachomatis (Aptima Combo 2 assay). Specific region with the 16S rRNA from C. trachomatis (Aptima CT assay). Both the Aptima Combo 2 assay and APTIMA CT assay detects nvCT. The test detects plasmid-free C. trachomatis. No false-positive tests based on analytical specificity testing. |
Specific region within the 16S rRNA from N.gonorrhoeae (Aptima Combo 2 assay). Specific region with the 16S rRNA from N. gonorrhoeae that is distinct from the Aptima Combo 2 assay target (Aptima GC assay). No false-positive tests based on analytical specificity testing. |
|
BD ProbeTec ET CT/GC Amplified DNA assay (Becton Dickinson and Company, Sparks, MD) |
One distinct sequence within the 7,500 base pair C. trachomatis cryptic plasmid DNA. The test does not detect plasmid-free C. trachomatis. No false-positive tests based on analytical specificity testing. |
Chromosomal pilin gene-inverting protein homologue. Neisseria cinerea, Neisseria subflava and Neisseria lactamica might result in false-positive test results based on analytical specificity testing. |
|
BD ProbeTec QX CT Amplified DNA Assay BD ProbeTec QX GC Amplified DNA Assay (Becton Dickinson and Company, Sparks, MD) |
One distinct sequence within the 7,500 base pair C. trachomatis cryptic plasmid DNA. The test does not detect plasmid-free C. trachomatis. No false-positive tests based on analytical specificity testing. |
Chromosomal pilin gene-inverting protein homologue. N. cinerea and N. lactamica might result in false-positive test results based on analytical specificity testing. |
|
Xpert CT/NG Assay (Cepheid, Sunnyvale, CA) |
One distinct C. trachomatis chromosomal DNA sequence. No false-positive tests based on analytical specificity testing. The test detects plasmid-free C. trachomatis. |
Two distinct chromosomal sequences each with a different reporter. Both sequences have to be detected to obtain a positive N. gonorrhoeae result. No false-positives based on analytical specificity testing |
|
cobasCT/NG test (Roche Diagnostics, Indianapolis, IN) |
CT primers CP102 and CP103 to define a sequence of approximately 206 nucleotides within the cryptic plasmid DNA of C. trachomatis. CT primers CTMP101 and CTMP102 to define a sequence of approximately 182 nucleotides within the chromosomal DNA of C. trachomatis. No false-positive tests based on analytical specificity testing. The test detects plasmid-free C. trachomatis. |
NG primers NG514 and NG519 to define a sequence of approximately 190 nucleotides (DR-9A) from the DR-9 region. NG primers, NG552 and NG579, to define a second sequence of approximately 215 nucleotides (DR-9B) from the DR-9 region. No false-positive tests based on analytical specificity testing. |