Abbott RealTime SARS-CoV-2 Assay

Curbing the COVID-19 Outbreak in RealTime

The Abbott RealTime SARS-C0V-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients who are suspected of COVID-19 by their healthcare provider.

icon-pdf.pngAbbott RealTime SARS-CoV-2 Instruction for Use

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Description
 

Abbott RealTime SARS-CoV-2 assay provides a fully automated solution to help laboratories address the urgent need for 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

 

Specifications
 
 
Assay Specifications*
Technology Qualitative Multiplex real time PCR
Probe Design Single Stranded Linear Probe
Target Region Dual Target, RdRp and N-genes
Assay Runtime**
Approximately 7 hours 
Throughput** 470 patient samples in 24 hours
 Specimen type Nasopharyngeal swabs, Oropharyngeal swabs
 Limit of Detection 100 copies/mL
Specificity 100%
Results Reporting Detected / Not Detected
Sample input volume 0.5 mL
Internal Control (IC) Armored RNA (Pumpkin), Added to each specimen and control
Controls One negative and one positive control per run
 
* Source: Abbott RealTime SARS-CoV-2 package insert 51-608442/R1
** Abbott data on file
WHO Guidance
 

Link to WHO's interim guidance on COVID-19 Testing: 

https://apps.who.int/iris/handle/10665/331329

 

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