Table 1.
FDA-approved nucleic-acid-based assays for detection of microbial pathogens
| Organism detected | Trade name | Company/institution | Method | Clinical sensitivity | Clinical specificity |
|---|---|---|---|---|---|
| Chlamydia trachomatis | Amplicor | Roche | PCR | 93·219 | 98·4119 |
| LCX | Abbott | LCR | >9519 | >9919 | |
| AMP | Gen-Probe | TMA | 86·7–99·219 | >9919 | |
| PACE 2 | Gen-Probe | Hybridisation | 60·8–78·135 | >9935 | |
| BDProbeTec | Becton Dickinson | SDA | 94·036 | >9936 | |
| Hybrid capture II CT-ID | Digene | Hybrid capture | 95·437 | 9937 | |
| Cytomegalovirus | CMV pp67 mRNA | Organon Teknika | NASBA | 9538 | 9838 |
| Hybrid capture CMV DNA test | Digene | Hybrid capture | 9539 | 9539 | |
| Gardnerella vaginalis | Affirm VIP III | Becton Dickinson | Hybridisation | 9440 | 8140 |
| Group A streptococcus | GP-ST test | Gen-Probe | Hybridisation | 88·619 | 97·819 |
| Group B streptococcus | IDI-StrepB | Infectio Diagnostics | Real-time PCR | 9719 | 10019 |
| HCV | Amplicor HCV | Roche | PCR | 9819 | NA |
| Versant HCV RNA qualitative assay | Bayer | TMA | NA | 9841 | |
| Versant HCV RNA 3·0 | Bayer | BDNA | NA | 98·242 | |
| HIV | Amplicor HIV-1 Monitor Test | Roche | RT-PCR | NA | >9919 |
| Trugene HIV drug resistance and OpenGene DNA sequencing | Visible Genetics | DNA sequencing | NA | NA | |
| NucliSens EasyQ HIV-1 | bioMerieux | NASBA | NA | >9919 | |
| Procleix HIV-1/HCV | Chiron | TMA | >9943 | >9943 | |
| Versant HIV-1 RNA 3·0 | Bayer | BDNA | 97·644 | ||
| ViroSeq | Applied Biosystems | DNA sequencing | NA | NA | |
| HPV | Hybrid capture II HPV DNA | Digene | Hybrid capture | >9945 | 85–9045 |
| M tuberculosis | TB Amplicor | Roche | PCR | 79·4–91·919 | >9919 |
| E-MTD | Gen-Probe | TMA | 90·9–95·219 | >9919 | |
| Neisseria gonorrhoeae | Amplicor | Roche | PCR | NA | NA |
| LCX | Abbott | LCR | >9519 | >9919 | |
| Hybrid capture II CT/GC | Digene | Hybrid capture | 9346 | 98·546 | |
| BDProbeTec | Becton Dickinson | SDA | 88·936 | >9936 | |
| PACE-2 | Gen-Probe | Hybridisation | 9735 | 9935 | |
| Trichomonas vaginalis | Affirm VIP III | Becton Dickinson | Hybridisation | 88–91 938 | 10038 |
BDNA=branched DNA; LCR=ligase chain reaction; NASBA=nucleic-acid-sequence-based amplification; PCR=polymerase chain reaction; RT-PCR=reverse transcriptase PCR; SDA=strand displacement amplification; TMA=transcription mediated amplification; NA=not applicable. Adapted from reference 19.