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SARS-CoV-2 Testing (RT-PCR)

SARS-CoV-2 Testing (RT-PCR)

SARS-CoV-2 Testing (RT-PCR)

Product catalog summary
Introduction
SARS-CoV-2 is a positive sense, single-stranded RNA virus responsible for COVID-19, declared a pandemic by WHO in March 2020. Effective diagnostic tools are crucial for controlling outbreaks, with real-time reverse transcription PCR (RT-PCR) being the gold standard for detecting current infections.
Assay Specifications
The ViennaLab SARS-CoV-2 RealFast™ Assay is a one-step RT-PCR test designed for the sensitive detection of SARS-CoV-2. It targets two specific viral genes, N and RdRP/ORF1ab, and includes a human ACTB gene-detecting control. The assay is highly sensitive with a limit of detection (LoD) of 10 copies per reaction and is compatible with various real-time PCR instruments.
Key Features
The assay is a multiplex one-tube reaction that has passed external quality assessments. It is essential for testing asymptomatic individuals, who may account for 40%-45% of infections, to control the pandemic effectively.
Interpretation of Results
The assay includes a reverse transcription step followed by TaqMan® fluorogenic 5‘ nuclease assay reactions. Positive samples generate fluorescence signals in the FAM and HEX channels, while negative samples show signals in the Cy5 channel due to the human ACTB gene.
Amplification Data
Amplification plots display fluorescent levels and curves for the assay targets: SARS-CoV-2 N gene (FAM channel), RdRP/ORF1ab gene (HEX channel), and human ACTB gene (Cy5 channel). These plots help differentiate between positive and negative samples.
WHO Guidelines
According to WHO's interim guidance from March 2020, COVID-19 case confirmation should be based on detecting unique virus RNA sequences using RT-PCR.
References
1. Oran D.P., Topol E.J. Prevalence of Asymptomatic SARS-CoV-2 Infection: A Narrative Review. Ann Intern Med. 2020;M20-3012.
2. World Health Organization (2020). Laboratory testing for coronavirus disease (COVID-19) in suspected human cases: interim guidance, 19 March 2020.
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Catalog excerpts

SARS-CoV-2 Testing (RT-PCR)-1

SARS-CoV-2 Testing One step real-time reverse transcription PCR (RT-PCR) assay for highly sensitive detection of SARS-CoV-2 Gold standard RT-PCR for rapid and sensitive SARS-CoV-2 identification SARS-CoV-2 is a positive sense, single stranded RNA respiratory virus that emerged in late 2019. Within two months, it spread globally, and coronavirus disease 2019 (COVID-19) was declared a pandemic by the WHO in March 2020. Although several countries have temporarily reduced the number of daily new cases, robust diagnostic tools facilitating the efficient control of new outbreaks are highly demanded. Quick and sensitive testing by using real-time reverse transcription PCR technology remains the gold standard to test for current infections. Importantly, asymptomatic persons seem to account for approximately 40% - 45% of SARS-CoV-2 infections.1 Due to this silent spread, it is essential to test also individuals without clinical or subclinical symptoms who suspectedly have been exposed to SARS-CoV-2, in order to control the pandemic locally, regionally and globally. The ViennaLab SARS-CoV-2 RealFast™ Assay allows for highly sensitive detection of two viral target genes (N and RdRP/ORF1ab), specific to SARS-CoV-2, in a one-tube reaction. Key Features • Multiplex one-tube reaction assay (human ACTB gene-detecting control included) • Two separate virus specific target genes: N and RdRP/ORF1ab • High sensitivity (LoD: 10 copies per reaction) • Successfully passed external quality assessment schemes • Compatibility with a wide range of real-time PCR instruments C € IIVDl Order Information: SARS-CoV-2 RealFast™ Assay: 8-410/8-412 (100/500 reactions)

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SARS-CoV-2 Testing (RT-PCR)-2

Continued In March 2020, the WHO stated in an interim guidance paper that the routine confirmation of cases of COVID-19 shall be based on detection of unique sequences of virus RNA (N, RdRP, S, and E genes) by real-time reverse transcription PCR.2 An integrated control assay for the human ACTB gene simultaneously monitors the performance of nucleic acid extraction and RT-PCR step. References: 1 Oran D.P., Topol E.J. Prevalence of Asymptomatic SARS-CoV-2 Infection: A Narrative Review. Ann Intern Med. 2020;M20-3012. 2 World Health Organization (2020). Laboratory testing for coronavirus disease...

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