DDW App note: Implementation and evaluation of SARS-CoV-2 detection assay

This paid-for app note by Analytik Jena appeared in DDW Volume 22, Issue 1 – Winter 2020/ 21.

December 2019 the novel SARS-CoV-2 (formerly named 2019-nCoV) was identified in Wuhan, the capital of China’s province Hubei. Based on its rapid spreading with more than 950,000 confirmed cases by the beginning of April 2020 the World Health Organisation declared the outbreak a public health emergency of international concern.

Application

Molecular assays to detect SARS-CoV-2 have been developed and are accessible through the homepage of the WHO. Furthermore, several commercial kits based on real-time PCR are available like:

• Procomcure Biotech GmbH, Thalgau, Austria: PhoenixDx SARS-CoV-2 IVD

The PhoenixDx SARS-CoV-2 IVD detects the presence of two individual and highly specific gene sequences of corona viruses: one identifies SARS-CoV-2, SARS-CoV, and bat-SARS-related coronaviruses (Sarbeco), one specifically targets SARS-CoV-2 (SARS-CoV-2). Addressing two different target sequences minimises the chance of false-negative results caused by an altered sequence. Additionally, a non-infectious positive control (TPC) and a negative human extraction control (HEC)are included. The positive control is used to confirm functionality of the assays and overall PCR performance, the negative human extraction control is included to evaluate the quality of the RNA isolation independently from the SARS-CoV-2 assays.

Materials and reagents

Procomcure Biotech GmbH validated PhoenixDx SARS-CoV-2 IVD on the qTOWER3 G by Analytik Jena and performed a non-clinical performance evaluation. The assay was used in qTOWER3 G with 10-fold dilutions of a starting concentration of 1 million copies.

Your Benefits

• Reliable real time PCR signals on the qTOWER3 G
• Instrumentation for detection of SARS, SARS-CoV-2 and other bat-associated SARS-related viruses (Sarbeco)
• Instrumentation for detection of SARS-CoV-2 specific sequence
• Maximum flexibility on qTOWER3 G

Results

Procomcure Biotech GmbH: PhoenixDx SARS-CoV-2 IVD

Conclusion

Procomcure Biotech GmbH successfully implemented and validated the PhoenixDX SARS-CoV-2 assay on the qTOWER3 G by Analytik Jena. Indicated qTOWER3 G settings result in stated performance of the assay based on the detection of both genes, E-Gene and the SARS-CoV2-specific RdRP-Gene. Please note that qTOWER3 G is intended for research use only.

Reference

This document is true and correct at the time of publication; the information within is subject to change. Other documents may supersede this document, including technical modifications and corrections.

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Image credit: CDC