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Tests for the qualitative detection of SARS-CoV-2 coronavirus, causative of COVID-19 infection, Flu and RSV viruses

Real SARS-CoV-2, Real SARS-CoV-2 PLUS and Real SARS-CoV-2/RSV/Flu products are three tests based on the PCR real time technique, that allows the qualitative detection and differentiation up to 3 specific genes (E, N and orf1ab) for SARS-CoV-2 Coronavirus, and also RSV and Flu viruses.

COVID-19 is an infectious disease caused by SARS-CoV-2, a sarcovirus-like coronavirus first detected in the Chinese city of Wuhan, Hubei province, in December 2019. In March 2020, the WHO declared it a pandemic.

As the symptoms of the COVID-19 disease might be similar to those caused by Flu or RSV viruses, it is important to diferentiate the cause of the infection in order to take the appropriate measures.

Most people infected with SARS-CoV-2 will develop mild to moderate symptoms, such as fever, fatigue or dry cough, but can also develop severe disease and even death, especially in older patients and/or those with pre-existing conditions.

Detection of RNA virus by techniques such as real-time RT-PCR is important in such infection because it can help health professionals to isolate infected persons quickly, thus containing the outbreak by preventing it from spreading. As a result, health authorities —such as China CDC, Charité-Germany, or US CD (1,2)— have issued several testing and gene detection protocols for the molecular diagnosis of SARS-CoV-2 infection.

The Real SARS-CoV-2 and Real SARS-CoV-2 PLUS products are tests for the easy and sensitive detection of SARS-CoV-2 virus by real time RT-PCR, with protocols available that do not require nucleic acid extraction. The Real SARS-CoV-2/RSV/Flu product also allows the detection of Flu and RSV viruses.

(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

posibilidad de no extracción del ARN

Possibility of non-extraction of RNA

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Detection of up to 3 genes

variedad tipos muestra validados

Identification of new variants

control endogeno interno

Endogenous internal control

Refrigerated transport

Our products for the qualitative detection of SARS-CoV-2 coronavirus, causative of COVID-19 infection

Product
Technique
Sample
Promocional Sheet
CE Decl.
Instruct.
Reference No.
Real SARS-CoV-2
PCR real time
RNA from saliva or nasopharyngeal, oropharyngeal or bucal swabs
5.233.048.88.000
5.233.096.88.000
Real SARS-CoV-2 PLUS
PCR real time
RNA/Lysed extract from saliva or nasopharyngeal, oropharyngeal or nasal swabs
5.239.048.88.000
5.239.096.88.000
Real SARS-CoV-2/Flu/RSV
PCR real time
RNA/Lysed extract from saliva or nasopharyngeal, oropharyngeal or nasal swabs
5.237.048.88.000
5.237.096.88.000

PCR can be performed without prior nucleic acid extraction. Only a short lysis process is needed, with reagents included in the kit. This shortens the analysis time and makes the process cheaper.

Detection up to 3 genes. Real SARS-CoV-2 allows the detection of an E gene region, specific to sarcovirus-like coronaviruses (SARS-CoV-1 and SARS-CoV-2), and a region of the orf1ab and N genes, specific to SARS-CoV-2; while the Real SARS-CoV-2 test allows the detection of 2 genes (E gene and orf1ab gene).

Genes detected are not affected by the mutations. This has been demonstrated in different in silico studies carried out with the tests. Therefore, the results obtained are reliable, minimizing the possibility of obtaining false negatives due to the appearance of new variants.

Several validated samples. The test has been designed and validated for use with DNA obtained from respiratory samples of different nature, allowing the professional to take the sample from one area or another to ensure that as much of the pathogen as possible is captured. Specifically, the kits have been validated with RNA extracted from nasopharyngeal swab, oropharyngeal swab, saliva or buccal/nasal swab (depending on the test).

The main advantage of using an endogenous internal control is that it allows checking that the extraction/lysis, retrotranscription, amplification and detection have been carried out correctly. In addition, by not having to add any extra reagents, the process is shortened and simplified.

Refrigerated transport avoids the use of dry ice, reducing costs and facilitating transport.

Publications

N.º
Title
Link
Language
1
Utility of a direct sample real time PCR for the follow up of SARS-CoV-2 infection with different respiratory samples
English

Webinars

“COVID-19, diagnostic tools”

Dr. María Alejandra Torres, haemato-oncologic and member of the Venezuelan COVID Commission, gives an interesting overview of all the diagnostic tools currently available for the detection of COVID-19.

The recorded webinar is available on demand. If you missed it, feel free to request it!

Online webinar about diagnostic tools for the detection of COVID-19 thanks to María Alejandra Torres
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information

    Frequently Asked Questions

    According to in silico tests, the tests detect all variants of interest (alpha, beta, epsilon, delta, gamma). The main mutations affect the spike protein (S), which is not detected by this kit. For the delta variant, no in vitro assay has been performed, but the data obtained by comparing primer and probe sequences with the new variants are strong enough to guarantee detection.
    The use has not been validated but is theoretically compatible, as the fluorochromes used are those detected by the device.

    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.