NAATs can use many different methods to amplify nucleic acids and detect the virus, including but not limited to:

Reverse transcription polymerase chain reaction (RT-PCR)

Isothermal amplification including:

Nicking endonuclease amplification reaction (NEAR)

Transcription mediated amplification (TMA)

Loop-mediated isothermal amplification (LAMP)

Helicase-dependent amplification (HDA)

Clustered regularly interspaced short palindromic repeats (CRISPR)

Strand displacement amplification (SDA)

The ABBOTT IDNOW NAAT test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

The Abbott BinaxNOW COVID-19 Ag Card, Rapid Antigen Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the quantitative detection of nucleocapsid protein antigen from SARS-CoV-2.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

NAATs can use many different methods to amplify nucleic acids and detect the virus, including but not limited to:

Reverse transcription polymerase chain reaction (RT-PCR)

Isothermal amplification including:

Nicking endonuclease amplification reaction (NEAR)

Transcription mediated amplification (TMA)

Loop-mediated isothermal amplification (LAMP)

Helicase-dependent amplification (HDA)

Clustered regularly interspaced short palindromic repeats (CRISPR)

Strand displacement amplification (SDA)

The ABBOTT IDNOW NAAT test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

The Abbott BinaxNOW COVID-19 Ag Card, Rapid Antigen Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the quantitative detection of nucleocapsid protein antigen from SARS-CoV-2.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

NAATs can use many different methods to amplify nucleic acids and detect the virus, including but not limited to:

Reverse transcription polymerase chain reaction (RT-PCR)

Isothermal amplification including:

Nicking endonuclease amplification reaction (NEAR)

Transcription mediated amplification (TMA)

Loop-mediated isothermal amplification (LAMP)

Helicase-dependent amplification (HDA)

Clustered regularly interspaced short palindromic repeats (CRISPR)

Strand displacement amplification (SDA)

The ABBOTT IDNOW NAAT test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.