Facts Sheet

SARS-CoV Testing

Interest Group

Health Facilities, Officials and Companies who would like to test for Corona Viruses in order to protect their employees, customers or patients and to prevent Corona spread in their teams or to their contacts, respectively. In GMP production: ATMP manufacturer, pharmaceutical industry, media manufacturer, Research and Development.

Description

Direct test service for SARS-CoV (Broad Range, Screen) and SARS-CoV-2 (Covid-19),  rapid and reliable results via qPCR. No clinical diagnostic testing!

Recommended Sample Material

Body fluids, tissue or biopsy material, cell culture materials, primarily swab material (different matrices on request).

Method

Qualitative Real-Time PCR.

Applied PCR System

ConviFlex-RT-Taq (Minerva Biolabs GmbH), CoV Screen (Minerva Biolabs GmbH), SARS-CoV-2 Confirm (Minerva Biolabs GmbH).

Applied Extraction

ExtractNow Virus RNA Kit (Minerva Biolabs GmbH), ExtractNow Virus Swab Kit (Minerva Biolabs GmbH), ExtractNow Virus DNA/RNA Kit (Minerva Biolabs GmbH).

Process Control

Reverse Transcription and Amplification.

Sample Volume / PCR

5 µl.

Average Turnaround Time

24 to 48 hours after sample receipt, express testing possible.

Sensitivity of Method

<100 K/PCR, <10000 Viral Genomes/ml.

Regulatory Compliance

Based on WHO suggestions and Corman et al. 2020 Eur. Surveillance.

Validation

Internal Validation, Ringtrial.

Sample Requirements

Screening program:     Swab

GMP: Native.

Minimum: at least 1.0 ml for single virus testing.

Optimum: 2 units of 1.0 ml each, label as sample A and sample B (backup, please mark in accession form).

Order No.

SARS CoV Screen                        46-1008
SARS CoV-2                                  46-1009

Volume Discount Available

Pooling program available on request for screening-program.

Additional Information

No clinical diagnostic testing.