Abbott RealTime SARS-CoV-2 Assay

Curbing the COVID-19 Outbreak in RealTime

The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria.

icon-pdf.png

Fact Sheet for Patients: Understanding Results from the Abbott RealTime SARS-C0V-2 EUA Assay Results

icon-pdf.png

Folleto Informativo para Pacientes: Entendiendo los resultados del ensayo Abbott RealTime SARS-CoV-2 EUA

icon-pdf.png

Fact Sheet for Healthcare Providers: Interpreting Abbott RealTime SARS-CoV-2 EUA Assay Results

icon-pdf.pngAbbott RealTime SARS-CoV-2 Assay Package Insert

 VIEW ORDERING INFORMATION 

Description
 

Abbott RealTime SARS-CoV-2 assay provides a fully automated solution to help laboratories address the urgent need for automated, high-volume patient testing during the Coronavirus (COVID-19) pandemic.

The assay is engineered with:

  • Dual target assay for RdRp and N-genes
  • Qualitative detection of nucleic acids from SARS-CoV-2
  • maxRatio data analysis removes operator subjectivity

The Abbott RealTime SARS-CoV-2 assay in combination with the RealTime m2000 system allow scalable, automated process for flexible testing volume (24-96 samples) and up to 470 patient samples in 24 hours.  

CDC Guidelines
 

Below are links to CDC website on:

Important Safety Information

INTENDED USE 

The Abbott RealTime SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at health care location or collected by a healthcare worker, nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker, from patients suspected of COVID-19 by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal, nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Abbott RealTime SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

LIMITATIONS OF PROCEDURE

For use under an Emergency Use Authorization only.

  • This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
  • Use of the Abbott RealTime SARS-CoV-2 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000 System.
  • Laboratories are required to report all positive results to the appropriate public health authorities.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
  • Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
  • Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
  • False-negative results may arise from degradation of the viral RNA during shipping/storage.
  • The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated.
  • As with any molecular test, mutations within the target regions of Abbott RealTime SARS-CoV-2 assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
  • Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. One hundred percent agreement between the results should not be expected due to aforementioned differences between technologies. Users should follow their own specific policies/procedures.
  • Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
  • Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.
  • Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.

Rx Only

This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.

  1. The Abbott RealTime SARS-CoV-2 assay has not been FDA cleared or approved;
  2. This test has been authorized by FDA under an EUA for use by authorized laboratories;
  3. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  4. 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

Ordering Info

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No