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Abbott ID NOW™ COVID-19

MOLECULAR. IN MINUTES. ON THE FRONT LINE.

ID NOW™ is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide.

The ID NOW™ COVID-19 assay is now available for use on the ID NOW platform under U.S. Food and Drug Administration Emergency Use Authorization (EUA). The ID NOW™ COVID-19 rapid test delivers high-quality molecular positive results in as little as 5 minutes, targeting the coronavirus (COVID-19) RdRp Gene.

 

DESCRIPTIOIN

The Abbott ID-NOW System can tell if someone is infected in as little as five minutes and is so small and portable it can be used in almost any health care setting. The molecular test looks for fragments of the coronavirus genome, which can quickly be detected when present at high levels. A thorough search to definitively rule out an infection can take up to 13 minutes. Abbott has received emergency use authorization from the U.S. Food and Drug Administration “for use by authorized laboratories and patient care settings”. The test starts with taking a swab from the nose or the back of the throat, then mixing it with a chemical solution that breaks open the virus and releases its RNA. The mixture is inserted into an ID Now system, a small box weighing just under 7 pounds that has the technology to identify and amplify select sequences of the coronavirus genome and ignore contamination from other viruses.

Isothermal nucleic acid amplification technology

Lightweight portable point of care system

Test Processing Time: 5-13 min

  • Timely results enable healthcare professionals to make appropriate and more efficient treatment and infection control decisions. EUA supports flexible near patient testing environments.

    Only available in the US.

- Positive results may be detected in as little as 5 minutes

- Negative results in 13 minutes

- Molecular technology targeting COVID-19 RdRp gene

- Designed for near patient testing in a variety of healthcare environments1

- Room temperature storage

- Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs

- Facilitates effective patient management


The ID NOW COVID-19 EUA 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.
SPECIFICATION

- Dimensions - 8.15” W x 5.71” H x 7.64” D (207 mm W x 145 mm H x 194 mm D)

- Small footprint enables ease of use at point of care

- Actionable results in 13 minutes or less

- Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs

- Simple operation via visual touchscreen

  • BENEFITS

    Positive results may be detected in as little as 5 minutes

    Negative results in 13 minutes

    Molecular technology targeting COVID-19 RdRp gene

    Designed for near patient testing in a variety of healthcare environments1

    Room temperature storage

    Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs

    Facilitates effective patient management

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