Table 1.

FDA-cleared RT-PCR Assays and Other Molecular Assays for Influenza Viruses
Products Manufacturer(s) Influenza Virus Type Detected Influenza A Other Respiratory Virus Subtype(s) Viruses Differentiated Differentiated
HI, H3, 2009 H1, H5N1 (Asian lineage)

Acceptable Specimens1
Nasopharyngeal swabs, nasal swabs, nasal aspirates, nasal washes, dual nasopharyngeal/ throat swabs, broncheoalveolar lavages, tracheal aspirates, bronchial washes, and viral culture Nasopharyngeal swabs, nasal swabs, and nasopharyngeal aspirates Nasopharyngeal swabs Nasopharyngeal swabs Nasopharyngeal swabs

Test Time2/ Complexity3

CDC Human Influenza Virus Real-Time RTPCR Diagnostic Panel4

CDC Influenza Division

Influenza A and B

None

~4 h/ High

Simplexa Influenza A H1N1 (2009) Simplexa Flu A/B & RSV Prodesse PROFLU+ Prodesse ProFAST+

Focus Diagnostics, 3M Focus Diagnostics, 3M GenProbe GenProbe

Influenza A Influenza A and B Influenza A and B Influenza A

2009 H1 None None H1, H3, 2009 H1

None RSV Respiratory Syncytial Virus None Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, 2, and 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus Respiratory Syncytial Virus Human Metapneumovirus, Rhinovirus, and Adenovirus Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B None None

<4h/ High <4h/ High <4h/ High <4h/ High

x-TAG Respiratory Viral Panel (RVP)

Luminex Molecular Diagnostics Inc.

Influenza A and B

H1, H3

Nasopharyngeal swabs

~8 h/ High

x-TAG Respiratory Viral Panel Fast (RVP FAST)) Verigene Respiratory Virus Nucleic Acid Test
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)

Luminex Molecular Diagnostics Inc. Nanosphere, Inc

Influenza A and B

H1, H3

Nasopharyngeal swabs

~6 h/ High 3.5 h/ Moderate

Influenza A and B

None

Nasopharyngeal swabs

Nanosphere, Inc

Influenza A and B

H1, H3, 2009 H1

Nasopharyngeal swabs

3.5 h/ Moderate ~4 h/ High ~4 h/ High

U.S. Army JBAIDS Influenza A/H54 U.S. Army JBAIDS Influenza A&B Detection Kit4

Idaho Technologies Idaho Technologies

Influenza A Influenza A and B

H5N1 (Asian Lineage) None

Nasopharyngeal and throat swabs Nasopharyngeal swabs and Nasopharyngeal washes

U.S. Army JBAIDS Influenza A Subtyping Kit4

Idaho Technologies

Influenza A

H1, H3, 2009 H1

None Respiratory Syncytial Virus, Parainfluenza 1, 2, 3 and 4 virus, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Coronavirus HKU1, Coronavirus NL63 None None

Nasopharyngeal swabs and Nasopharyngeal washes

~4 h/ High

FilmArray Respiratory Panel

Idaho Technologies

Influenza A and B

H1, H3, 2009 H1

Nasopharyngeal swabs

1.0 h/ Moderate

IQuum Liat Influenza A/B Assay Cepheid Xpert Flu Assay

IQuum Cepheid

Influenza A and B Influenza A and B

None 2009 H1

Nasopharyngeal swabs Nasopharyngeal swabs, nasal aspirates, and nasal washes,

0.5 h/ Moderate 1.0 h/ Moderate

Quidel Molecular Nasopharyngeal swabs and ~4 h/ Quidel Influenza A and B None None Influenza A+B Assay nasal swabs High Qiagen Artus Influenza ~4 h/ A/B Rotor-gene RTQiagen Influenza A and B None None Nasopharyngeal swabs High PCR kit 1 These specimen types are specified in product package inserts cleared by the U.S. Food and Drug Administration (FDA) 2 Test Time is inclusive of actual test time and is exclusive of transport, handling, laboratory run schedules, and generating results. Timing may vary depending on extraction process used. Contact laboratory for expected turn-around time. 3 Clinical Laboratory Improvement Amendments require categorization of tests as waived, moderate or high complexity. 4 Available only to qualified DoD laboratories, U.S. public health laboratories, and NREVSS collaborating laboratories.