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Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014


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.

 

 
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