Table 1.
Commercially available nucleic acid amplification assays for viral pathogens a.
| Product | Company | Chemistry | Viral Pathogens |
|---|---|---|---|
| Abbott RealTime CMV | Abbott | Real-time PCR | CMV |
| Aptima HPV 16 18/45 Genotype Assay | Hologic | Real-time PCR | HPV |
| artus CMV RGQ MDx Kit | Qiagen | Real-time PCR | CMV |
| artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | Real-time PCR | HSV 1, HSV 2 |
| BD Onclarity™ HPV Assay | Becton Dickinson | Real-time PCR | HPV |
| COBAS® AmpliPrep/COBAS® TaqMan® CMV Test | Roche Molecular Diagnostics | Real-time PCR | CMV |
| COBAS®AmpliPrep/COBAS® TaqMan® HBV Test, v2 | Roche Molecular Diagnostics | Real-time PCR | HBV |
| cobas® CMV Test | Roche Molecular Diagnostics | Real-time PCR | CMV |
| cobas® HBV test | Roche Molecular Diagnostics | Real-time PCR | HBV |
| cobas® HPV Test | Roche Molecular Diagnostics | Real-time PCR | HPV |
| Lyra Adenovirus Assay | Quidel | Real-time PCR | Adenovirus |
| Prodesse ProAdeno™+ Assay | Hologic | Real-time PCR | Adenovirus |
| Sentosa SA201 HSV-1/2 PCR Test | Vela Diagnostics | Real-time PCR | HSV 1, HSV 2 |
| Simplexa™ HSV 1 & 2 Direct assay | Focus Diagnostics | Real-time PCR | HSV 1, HSV 2 |
| Simplexa™ Influenza A H1N1 (2009) | Focus Diagnostics | Real-time PCR | Flu A and 2009 H1N1 |
| FilmArray® Respiratory Panel (RP) | BioFire Diagnostics | Nested multiplex RT-PCR | Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), hMPV, RSV, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza 1,2,3,4, Rhinovirus/ Enterovirus |
| FilmArray® Respiratory Panel 2 (RP2) | BioFire Diagnostics | Nested multiplex RT-PCR | Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), hMPV, RSV, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza 1,2,3,4, Rhinovirus/ Enterovirus |
| FilmArray® Respiratory Panel EZ (RP EZ) | BioFire Diagnostics | Nested multiplex RT-PCR | Adenovirus, hMPV, Coronavirus, Rhinovirus/Enterovirus, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza, RSV |
| FilmArray Gastrointestinal (GI) Panel | BioFire Diagnostics | Nested multiplex RT-PCR | Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A · Sapovirus (I, II, IV, and V) |
| Abbott RealTime HCV Genotype II | Abbott | RT-PCR | HCV |
| Abbott RealTime HBV Viral Load Assay | Abbott | RT-PCR | HBV |
| Abbott RealTime HCV Viral Load Assay | Abbott | RT-PCR | HCV |
| artus® Infl A/B RG RT-PCR Kit | Qiagen | RT-PCR | Flu A, Flu B |
| Abbott RealTime HIV-1 Viral Load Assay | Abbott | Real-time RT-PCR | HIV-1 |
| AMPLICOR HIV-1 MONITOR™ Test, v1.5 | Roche Molecular Diagnostics | Real-time RT-PCR | HIV-1 |
| Aptima HPV 16 18/45 Genotype Assay | Hologic | Real-time PCR | HPV |
| artus CMV RGQ MDx Kit | Qiagen | Real-time PCR | CMV |
| artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | Real-time PCR | HSV 1, HSV 2 |
| BD Onclarity™ HPV Assay | Becton Dickinson | Real-time PCR | HPV |
| CDC DENV-1-4 Real-Time RT-PCR Assay | CDC | Real-time RT-PCR | Dengue virus |
| COBAS® AMPLICOR HIV-1 MONITOR™ Test | Roche Molecular Diagnostics | Real-time RT-PCR | HIV-1 |
| COBAS® AmpliPrep/COBAS® TaqMan® CMV Test | Roche Molecular Diagnostics | Real-time PCR | CMV |
| COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Test | Roche Molecular Diagnostics | Real-time RT-PCR | HIV-1 |
| COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2 | Roche Molecular Diagnostics | Real-time PCR | HBV |
| COBAS® AmpliPrep/COBAS® TaqMan® HCV Test | Roche Molecular Diagnostics | Real-time RT-PCR | HCV |
| cobas® CMV Test | Roche Molecular Diagnostics | Real-time PCR | CMV |
| cobas® HCV Test | Roche Molecular Diagnostics | Real-time RT-PCR | HCV |
| Prodesse Pro hMPV + Assay | Hologic | Real-time RT-PCR | hMPV |
| RIDA GENE Norovirus GI/GII | R-Biopharm AG | Real-time RT-PCR | Norovirus GI/GII |
| Simplexa™ Flu A/B & RSV | Focus Diagnostics | Real-time RT-PCR | Flu A/B & RSV |
| Simplexa™ Flu A/B & RSV Direct | Focus Diagnostics | Real-time RT-PCR | Flu A, Flu B, RSV |
| eSensor® Respiratory Viral Panel | GenMark Diagnostics, Inc. | Multiplex real-time PCR | Adenovirus, Rhinovirus, hMPV, RSV A, RSV B, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza 1,2,3 |
| Lyra Direct HSV 1 + 2/VZV Assay | Quidel | Multiplex real-time PCR | HSV 1, HSV 2, VZV |
| Lyra RSV + hMPV Assay | Quidel | Multiplex real-time PCR | RSV, hMPV |
| Lyra™ Parainfluenza Virus Assay | Quidel | Multiplex real-time PCR | Parainfluenza 1,2,3 |
| Panther Fusion AdV/hMPV/RV assay | Hologic | Multiplex real-time PCR | Adenovirus, hMPV, Rhinovirus |
| Panther Fusion Flu A/B/RSV assay | Hologic | Multiplex real-time PCR | Flu A, Flu B, RSV |
| Panther Fusion Paraflu assay | Hologic | Multiplex real-time PCR | Parainfluenza 1,2,3,4 |
| Prodesse ProFAST®+ Assay | Hologic | Multiplex real-time PCR | Flu A/H1, seasonal influenza A/H3 and 2009 H1N1 |
| Prodesse ProFlu® + assay | Hologic | Multiplex real-time PCR | Flu A, Flu B, RSV |
| Prodesse ProParaflu + assay | Hologic | Multiplex real-time PCR | Parainfluenza 1, 2, 3 |
| cobas® Liat Influenza A/B & RSV | Roche Molecular Diagnostics | Multiplex real-time RT-PCR | Flu A, Flu B, RSV |
| ePlex® Respiratory Pathogen Panel | GenMark Diagnostics, Inc. | Multiplex PCR and multiplex RT-PCR | Adenovirus,Coronavirus (229E, HKU1, NL63, OC43), hMPV, RSV A, RSV B, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza 1,2,3,4, Rhinovirus/ Enterovirus |
| Idylla Respiratory (IFV-RSV) Panel | Janssen Diagnostics | Multiplex real-time RT-PCR | Flu A, RSV |
| Lyra Influenza A + B Assay | Quidel | Multiplex real-time RT-PCR | Flu A, Flu B |
| NxTAG® Respiratory Pathogen Panel | Luminex Corporation | Multiplex RT-PCR | Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), hMPV, RSV, Flu A [Subtype A H1, A H3], Flu B, Parainfluenza 1,2,3,4, Rhinovirus/ Enterovirus, Bocavirus |
| VERIGENE® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Luminex Corporation | Multiplex RT-PCR + microarray detection | Adenovirus, hMPV, Flu A [Subtype H1, H3], Flu B, RSV A, RSV B, Parainfluenza 1,2,3,4, Rhinovirus |
| Xpert® Norovirus | Cepheid | Multiplex real-time RT-PCR | Norovirus GI/GII |
| Xpert® Xpress Flu/RSV | Cepheid | Multiplex real-time RT-PCR | Flu A, Flu B, RSV |
| xTAG® Gastrointestinal Pathogen Panel (GPP) | Luminex Corporation | Multiplex RT-PCR | Norovirus GI/GII, Rotavirus A |
| xTAG® Respiratory Viral Panel FAST | Luminex Corporation | Multiplex end point RT-PCR | Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), hMPV, RSV, Flu A [Subtype A H1, A H1-2009, A H3], Flu B, Parainfluenza 1,2,3,4, Rhinovirus/ Enterovirus, Bocavirus |
| ARIES® HSV1&2 Assay | Luminex Corporation | MultiCode® RTx | HSV 1, HSV 2 |
| ARIES® Flu A/B & RSV Assay | Luminex Corporation | Multicode® RTx | Flu A, Flu B, RSV |
| NUCLISENS® CMV PP67 | Organon Teknika Corp. | NASBA | CMV |
| NUCLISENS® EASYQ® HIV-1 v2.0 | bioMérieux | Real-time NASBA | HIV-1 |
| NUCLISENS® EASYQ® HPV | bioMérieux | Real-time NASBA | HPV |
| Aptima HSV 1 & 2 assay | Hologic | Real-time TMA | HSV 1, HSV 2 |
| Aptima HCV Quant Dx Assay | Hologic | Real-time TMA | HCV |
| Aptima HBV Quant Dx Assay | Hologic | Real-time TMA | HBV |
| illumigene® HSV 1&2 DNA Amplification Assay | Meridian Bioscience, Inc. | LAMP | HSV 1, HSV 2 |
| Alere™ i Influenza A & B Test | Abbott | NEAR | Flu A, Flu B |
| Alere™ i RSV | Abbott | NEAR | RSV |
| AmpliVue® HSV 1 + 2 Assay | Quidel | HDA | HSV 1, HSV 2 |
| Solana® HSV 1 + 2/VZV Assay | Quidel | HDA | HSV 1, HSV 2, VZV |
| Solana® Influenza A + B Assay | Quidel | Real-time RT-HDA | Flu A, Flu B |
| Solana® Respiratory Viral Panel | Quidel | Real-time RT-HDA | RSV A, RSV B, hMPV, Flu A, Flu B |
| VERSANT® HIV-1 RNA 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics | bDNA | HIV-1 |
| Versant HCV 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics | bDNA | HCV |
| digene HC2 HPV DNA Test | Qiagen | Hybrid Capture | HPV |
a
FDA 510(k) Premarket Notification. (2018). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed on November 14, 2018.