Table 2.

Emergency Use Authorization (EUA) Tests for the Detection of 2009 Pandemic Influenza A (H1N1)^a

Manufacturer name and test name	Date	TBT method	Instrument	Specimen types	Gene targets
1. CDC Human Influenza Virus Real time RT-PCR Detection panel	2 May 2009	Real-time RT-PCR	Roche LightCycler 2.0	NPS, NS, TS, NPS/TS	FluA M
	18 Dec 2009	Real-time RT-PCR	ABIe 7500 Fast Dx ABI 7500	NA, BAL, BA, BW, EA	swFluA NP
	18 Dec 2009	Real-time RT-PCR	JBAIDSf	EW, TA, lung tissue	swH1FluA HA
				Viral culture
2. Cepheid Xpert Flu A Panel	24 Dec 2009	Real-time RT-PCR	Cepheid GeneXpert Dx	NA, NW, NPS	FluA M, swH1FluA HA
3. Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit	16 Feb 2010	DFA	NAP	DFA positive with FDA- cleared test	…
4. DIATHERIX Laboratories H1N1-09 Influenza Test	9 Oct 2009	PCR	ABI 9700	NPS, NS, TS, NA, NPA	swH1FluA HA
		Bead detection	Qiagen Luminex LiquiChip 100	NPS, NS, TS, NA, NPA	swH1FluA NAG
5. DxNA GeneSTAT 2009 A/H1N1Influenza Test	9 Dec 2009	Real-time RT-PCR	GeneSTAT System	NPS, NS	FluA M, swH1FluA HA
6. ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test	1 Feb 2010	Real-time RT-PCR	ABI 7900HT	NPS, NS, TS, NA, NWNPS/TS, BAL, BA, BW, EA, EW, TA, lung tissue	FluA M
					swH1FluA HA
7. Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR	18 Dec 2009	Real-time RT-PCR	ABI 7500	NPS, NS, TS, NA, NWNPS/TS, BAL, BA, BW, EA, EW, TA, lung tissue	FluA M
					swH1FluA HA
8. Focus Diagnostics Simplexa Influenza A H1N1 (2009) Test	18 Dec 2009	Real-time RT-PCR	3M Integrated Cycler	NPS, NS, TS, NA, NWNPS/TS, BAL, BA, BW, EA, EW, TA, lung tissue	FluA M
					swH1FluA HA
9. Intelligent MDx IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay	22 Mar 2010	Real-time RT-PCR	ABI 7500ABI 7500 FastABI 7500 Fast Dx	NPS, NS, TS, NA, NWNPS/TSNPS/TS	swH1 FluA HAswH1 FluA HAswH1 FluA HA
10. Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay	16 Feb 2010	Real-time RT-PCR	ABI 7500	NW	FluA M, swH1FluA HA
11. Prodesse ProFlu-ST Influenza A Assay for the Diagnosis of 2009 H1N1 Influenza Infection	27 Oct 2009	Real-time RT-PCR	Cepheid SmartCycler II	NPS	sH1FluA HA, sH3FluA HA, swH1FluA NP
12. Qiagen artus Influenza A H1N1 2009 LC RT-PCR Kit	11 Mar 2010	RT-PCR	Roche LightCycler 2.0	NPS	FluA M, swH1 FluA HA
13. Roche RealTime Ready Influenza A/H1N1 Test	13 Nov 2009	Real-time RT-PCR	Roche LightCycler 2.0	NS, NPS, NW, NA	FluA M2, swH1FluA HA
14. TessArray Resequencing Influenza A Microarray Detection Panel	16 Dec 2009	RT-PCR	Affymetrix	TS	FluA NAG, NSG, M
		Resequencing microarray	GeneChip	TS	sH1FluA M, NAG, HA, sH3 FluA M
15. ViraCor 2009 H1N1 Influenza A Real-time RT-PCR	21 Jan 2010	Real-time RT-PCR	ABI 7500	NPS, NS, TS, NA, NWNPS/TS, BAL, BA, BW, EA, EW, TA, lung tissue	FluA MswH1FluA HA

NOTE. Table reflects status as of 22 March 2010. The EUAs for all tests listed were rescinded as of 23 June 2010. As of July 2010, 2 of these tests have received FDA approval for use as an in vitro diagnostic device for the diagnosis of 2009 pandemic influenza A H1N1; new optimized CDC H1N1 assay that is available in CDC-qualified laboratories; Focus Diagnostics Simplexa Influenza A H1N1 (2009). ABI, Applied Biosystems; aFluA, avian influenza A; BA, bronchial aspirate; BAL, bronchial alveolar lavage; BW, bronchial wash; EA, endotrachael aspirate; EW, endotrachael wash; FluA, all influenza A; HA, hemagglutinin gene; JBAIDS, Joint Biological Agent Identification and Diagnostic System (Centers for Disease Control and Prevention); M, matrix gene; M2, matrix gene 2; NAG, neuraminidase gene; NAP; not applicable; NA, nasal aspirate; NP, nucleoprotein gene; NPS, nasopharyngeal swab; NPS/TS, dual specimen consisting of nasopharyngeal swab and throat swab; NS, nasal swab; NSG, nonstructural gene; NW, nasal wash; sH1 FluA, seasonal influenza A H1N1; sH3 FluA, seasonal influenza A H3N2; swFluA, all variants of swine influenza A; swH1 FluA, 2009 pandemic influenza A (H1N1); TA, tracheal aspirate; TS, throat swab.

^aDate of FDA authorization of latest amendment.