Table 1.
Food and Drug Administration-Approved/Cleared Tests for the Detection of Respiratory Pathogens (as of July 2010)
| Manufacturer and test name | Year approveda | Test method | Instrument | Specimen type | Gene target |
| 1. Gen-Probe Amplified Mycobacterium tuberculosis Direct Test (AMTD) | 1995 | TMA, HPA | Gen-Probe Leader 50 | AFB smear-positive and smear-negative respiratory specimens | M. tuberculosis complex rRNA |
| 2. Gen-Probe/Prodesse ProFlu+ | 2008 | Real-Time RT-PCR | Cepheid SmartCycler | Nasopharyngeal swab in VTM | RSV P, influenza A M, influenza B NS1 and NS2 |
| 3. Gen-Probe/Prodesse Pro hMPV | 2008 | Real-Time RT-PCR | Cepheid SmartCycler | Nasopharyngeal swab in VTM | hMPV NC |
| 4. Gen-Probe/Prodesse ProParaFlu+ | 2009 | Real-Time RT-PCR | Cepheid SmartCycler | Nasopharyngeal swab in VTM | PIV-1, 2, 3 HN |
| 5. Luminex xTAG Respiratory Virus Panel | 2008 | RT-PCR, TSPE, bead hybridization | Luminex xMap 100/200 | Nasopharyngeal swab in VTM | Influenza A M and HA, influenza B HA, hMPV NP, RSV RP, PIV-1, 2, 3 HA, adenovirus HEX, rhinovirus 5' UTR |
| 6. Nanosphere Verigene | 2009 | RT-PCR, gold nanoparticle hybridization | Verigene Processor, Verigene Reader | Nasopharyngeal swab in VTM | Influenza A M, influenza B M and NS, RSV L and F |
| 7. Roche Amplicor Mycobacterium tuberculosis Direct Test | 1996 | PCR, colorimetric detection | Thermocycler EIA reader | AFB smear-positive respiratory specimens | M. tuberculosis complex rDNA |
NOTE. AFB, acid-fast bacilli; EIA, enzyme immunoassay; F, fusion gene; HA, hemagglutinin gene; HEX, hexon gene; hMPV, human metapneumovirus; HN, hemagglutinin-neuraminidase genes; HPA, hybridization protection assay; L, L nucleocapsid gene; M, matrix gene; NC, nucleocapsid gene; NP, nucleoprotein gene; NS, nonstructural gene; P, polymerase gene; PIV-1, 2, 3, parainfluenza virus types 1, 2, and 3; rDNA, ribosomal DNA; rRNA, ribosomal RNA; RP, RNA polymerase gene; RSV, respiratory syncytial virus; RT-PCR, reverse transcription polymerase chain reaction; TMA, transcription-mediated amplification; TSPE, target-specific primer extension; UTR, untranslated region; VTM, viral transport medium.
Year of initial FDA approval/clearance.