RIVM Evaluation's NaGene COVID-19 PCR kit: 'an attractive alternative to extraction based qRT-PCR'

June 10th, 2020




June 10th, 2020 -- KASSEL, GERMANY - HYCOR Biomedical today announced that the National Institute for Public Health and the Environment (RIVM) has released the results for the Evaluation of NaGene COVID-2019 direct PCR kit for SARS-CoV-2 detection.


On May 1st, Beijing NaGene Diagnosis and HYCOR Biomedical partnered on a mission of helping to save lives around the novel coronavirus outbreak areas providing high quality direct RT-PCR test solutions.


Fei Li, CEO of HYCOR Biomedical: “It is a challenging time for the whole world. For this reason and as a response to the pandemic, at HYCOR we are pleased to be helping laboratories and healthcare systems providing them with high-quality COVID-19 testing. With quick and accurate tests, patients are able to receive the healthcare and treatment they need”.


Routine in vitro diagnostics of respiratory RNA viruses is generally performed by means of quantitative reverse-transcription polymerase chain reaction (qRT-PCR) on purified RNA isolated from nasopharyngeal and/or oropharyngeal swabs in a separate process. In contrast, direct PCR is an approach in which the qRT-PCR is directly performed on the clinical specimen without prior extraction and purification of the RNA (J de Jonge, J et al. 2020).


One of the evaluation’s main findings is that direct RT-qPCR may be an attractive alternative to current extraction-based qRT-PCR used for laboratory confirmation of SARS-CoV-2 infection when using NaGene Preservation Buffer. This was proven during a sampling study conducted to compare two different transport media (GLY and Preservation Buffer). In nasopharyngeal swab specimens obtained from hospitalized COVID-19 patients, Ct values were lower for the clinical specimens stored in PB when compared to the same clinical sample collected in GLY medium. Collection in PB also significantly increased the sensitivity when compared to the benchmark in-house E-gene qRT-PCR using GLY transport medium. The average Ct difference between E-gene using GLY specimen and NaGene within the same patient was 2.7 (SD 1.1) when the specimen was collected in PB whereas when collected in GLY transport medium the difference was 5.4 Ct (SD 1.1). Furthermore, the Nagene COVID-2019 direct PCR kit detects SARS-CoV-2 positive clinical specimens collected in GLY transport medium with a Ct value below approximately 31 (RIVM in-house reference qRT-PCR) and produced significantly lower Ct values (~ 2.7 Ct values) when Preservation Buffer was used.


Furthermore, in a small comparative study, nasopharyngeal swabs directly stored in Preservation Buffer and analyzed by the NaGene assay resulted in a similar detection rate as compared to the currently used testing strategy with specimens having a Ct up to approx. 34 in an in-house reference assay and 32.6 in the NaGene assay.


In conclusion, in combination with the supplied Preservation Buffer, the NaGene kit is a very attractive, short time to result and accurate alternative to extraction-based qRT-PCR for SARS-CoV-2 detection assays.


About the National Institute for Public Health and the Environment (RIVM)


The National Institute for Public Health and the Environment (RIVM) has been promoting public health and safeguarding a healthy environment for more than 100 years. RIVM National Institute for Public Health and the Environment has a central role in infectious disease control and national prevention and population screening programs. They conduct independent (scientific) research in the field of Public Health, Health Services, Environmental Safety, and Security. In their role as a trusted advisor, they support citizens, professionals, and governments in the challenge of keeping the environment and ourselves healthy.


About Beijing NaGene Diagnosis Co., Ltd


Beijing NaGene Diagnosis Reagent Co., Ltd was established in 2015 and is located in the Biomedical Park of Beijing Economic and Technological Development Zone. It is mainly engaged in the research, development, production, and sales of molecular diagnostic reagent products.

With the goal of "creating fast technology; setting up high-quality consciousness and making brand reagents", the company has cooperated with many well-known national research institutions and medical units to produce a new set of pathogenic nucleic acid extraction and fluorescent PCR amplification technology. The company is committed to providing fast, efficient, practical, complete, reliable, and innovative products and solutions for the clinical nucleic acid detection market. For more information, please visit www.nagened.com

About HYCOR Biomedical


Founded in 1981, HYCOR is a global manufacturer and marketer of in-vitro diagnostics products. Among its products, HYCOR markets the NOVEOS Immunoassay Analyzer and testing reagents for allergen sensitization testing, the first breakthrough in routine allergy testing in 20 years, requiring 1/10 the sample per test compared to older methods. HYCOR also markets its HYTEC® legacy line of products by which millions of tests have been processed for clinicians around the world assessing patients for allergy or autoimmune diseases. Beyond the allergy focus, the company’s response to the pandemic is to provide laboratories and healthcare systems with high-quality COVID-19 testing, offering the highest value to clinicians and laboratories through innovation, reliability, and customer service. For more information, please visit www.HYCORbiomedical.com




References:

J de Jonge, B van der Veer, P van Kasteren, S van den Brink, L Wijsman, A van Esburg, J Murk, A Meijer (2020). Evaluation of NaGene COVID-2019 direct PCR kit for SARS-CoV-2 detection. National Institute for Public Health and the Environment (RIVM). Available from: http://www.nagened.com/newsitem/278501084 [Accessed: 10-Jun-20]




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