The Real SARS-CoV-2 and Real SARS-CoV-2 PLUS kits are three real-time PCR panels designed for reliable and efficient detection of SARS-CoV-2, with optimised protocols that do not require nucleic acid extraction, speeding up sample processing. In addition, the Real SARS-CoV-2/Flu/RSV test offers a comprehensive solution by enabling the simultaneous detection of SARS-CoV-2, Influenza and RSV, facilitating a more complete diagnostic response in hospital and laboratory settings.
COVID-19 is an infectious disease caused by SARS-CoV-2, a coronavirus of the betacoronavirus group and belonging to the subgenus sabercovirus, first identified in Wuhan (China) in December 2019. The World Health Organisation (WHO) declared a pandemic in March 2020, due to its rapid global spread. Although most patients present with mild to moderate symptoms (fever, fatigue, dry cough), some may develop severe forms of the disease, especially older people or those with comorbidities.
As COVID-19 symptoms may overlap with seasonal influenza (Influenza) and RSV, accurate differentiation is crucial to optimise treatment, hospital management and epidemiological control measures. Viral RNA detection by real-time RT-PCR is the reference method recommended by agencies such as China CDC, Charité – Germany and US CDC (1, 2), as it allows a rapid, sensitive and specific diagnosis, contributing to curb virus transmission by early isolation of positive cases.
(1) World Health Organization, https://www.who.int/docs/default-source/coronaviruse/protocol-v2-1.pdf, last accessed January 17, 2020
(2) Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases. Interim guidance 2 March 2020, WHO
Possibility of non-extraction of RNA
Detection of up to 3 genes
Identification of new variants
Endogenous internal control
Refrigerated transport
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Product
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Technique
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Sample
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Promocional Sheet
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CE Decl.
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Reference No.
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Real SARS-CoV-2
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PCR real time
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RNA from saliva or nasopharyngeal, oropharyngeal or bucal swabs
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5.233.048.88.000
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5.233.096.88.000
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Real SARS-CoV-2 PLUS
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PCR real time
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RNA/Lysed extract from saliva or nasopharyngeal, oropharyngeal or nasal swabs
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5.239.048.88.000
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5.239.096.88.000
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|||||
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Real SARS-CoV-2/Flu/RSV
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PCR real time
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RNA/Lysed extract from saliva or nasopharyngeal, oropharyngeal or nasal swabs
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5.237.048.88.000
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5.237.096.88.000
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The assay time is similar in all thermal cyclers, with only small variations due to the time it takes for each device to reach the temperatures of each cycle. In the validated thermal cyclers, the differences are less than 10 minutes. Thus, Quantum Studio and CFX take about 80 min, with ramps of 1.6 ºC/s, and Tianlong’s take about 70 min, with ramps of 6 ºC/s. Lighcycler defaults to 4.4 ºC/s.
The channels are equivalent. Only one, whichever is available, should be selected, as each thermal cycler usually contains only one of each group.
The different genes have similar sensitivity. Differences are mainly due to the design of the assay. In most cases, all genes can be detected in positive samples. Thus, most assays targeting more than one gene require the detection of at least 2 genes to provide a clear positive result. In some cases, only 1 or 2 of them are detected, with the N gene being one of the most frequently detected alone. This may be due to a low amount of viral load (early or late in the infection), but also to false positive results, or to reagent contamination with a specific gene. In most tests, if only the N gene is detected, the result would be considered inconclusive, and further testing would be necessary.
The internal control is endogenous, which means that it does not have to be added. This avoids possible errors in the procedure and ensures that all steps (extraction, retrotranscription, amplification) are correct.
