COVID-19 TESTING

COVID-19 TESTING

COVID-19 Testing Solutions

A comprehensive product portfolio is essential to support the tremendous efforts of health authorities working on SARS-CoV-2 detection and COVID-19 control globally. Eurofins Technologies teams have worked diligently in close collaboration with leading research hospitals and many of Eurofins human clinical testing laboratories around the world to develop a broad range of testing methods to support healthcare providers.

Real-Time PCR Assays

Direct pathogen detection via PCR is the method of choice to detect acute COVID-19 infections. PCR allows for detection a few days after infection as well as in subclinical / asymptomatic infections.

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR is a Multiplex Real-Time PCR for the direct qualitative pathogen detection of the novel Coronavirus (SARS-CoV-2). Particularly in the early phase of a virus infection, the direct diagnostic of the pathogen is key.

Key Benefits

  • Simultaneous detection of two target sequences
  • Approximately 1 hour turnaround time
  • Sample processing time improved fourfold with 384 run format
  • Reduced reaction volume
  • Increased endpoint fluorescence and robustness of the assay
  • Extraction/inhibition control included
  • Increased volume of Positive Control
 • New feature: validated for saliva and pharynx gargle samples

GSD NovaPrime SARS-CoV-2 Direct RT-PCR NEW!

The GSD NovaPrime® SARS-CoV-2 Direct RT-PCR is intended for the qualitative detection of SARS-CoV-2 from human nasopharyngeal swabs, eluted directly into deionised water without an additional RNA extraction process (extraction-free).

  • Validated as an extraction-free method
  • Results in approximately one hour from sample to result without compromising the high accuracy of PCR testing
 

GSD NovaType SARS-CoV-2 Detect & ID NEW!

The new molecular solutions detect SARS-CoV-2 variants B.1.1.7 (UK) and B.1.351 (South Africa) with a short turn-around time. Complement your existing PCR kit with our ID assay, or benefit from our full solution from diagnosis to identification with our Detect & ID kit

  • Assay Design: Real-Time RT-PCR test for the qualitative detection of SARS-CoV-2, and the subsequent
    identification of B.1.1.7 (UK) and B.1.351 (South Africa) variants
  • Kit Contents for Diagnostics (CE-IVD): RT-PCR Enzyme Mix, Primer-Probe-Mix, Extraction, and Positive Controls.
  • Kit Contents for Identification: Primers and Probes
  • Specimen types: nasal, nasopharyngeal, oropharyngeal, BAL, pharynx gargle
  • 2-Steps workflow: RT-PCR diagnosis + positive samples run for lineage identification

GSD NovaType SARS-CoV-2 ID NEW!

  • Assay Design: Real-Time RT-PCR test for the identification of B.1.1.7 (UK) and B.1.351 (South Africa) variants
    on positive PCR samples
  • Kit Contents: RT-PCR Enzyme Mix, Primers and Probes
  • For Research Use Only (RUO)

Antigen Rapid Tests

The GSD NovaGen SARS-CoV-2 (COVID-19) Antigen Rapid Test is intended for the qualitative detection of antigens from SARS-CoV-2 in a clinical specimen. The GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test provides reliable results from nasopharyngeal samples within 15 minutes. With diagnostic sensitivity of 92.6% and diagnostic specificity of 98.6%, the test meets WHO performance criteria (sensitivity ≥ 80%; specificity ≥ 97%) for use in the global fight against COVID-19.

Key Benefits

  • Fast and reliable results in 15 minutes
  • Cost-effective and easy to use; no additional special equipment required
  • Transportation and storage at room temperature
  • Diagnostic Sensitivity: 92.6%; Diagnostic Specificity: 98.6%
  • CE-IVD marked

Sanger Fragment Length Analysis Kits

The GSD NovaPrime® SARS-CoV-2 Mplex FLA (Sanger) kit utilizes the well-established Fragment Length Analysis principle on Sanger sequencing instruments (e.g. ABI 3730xl). This kit enables the specific detection of two N-gene fragments (N1 & N2) of the SARS-CoV-2 virus and its multiplex reactions include a human housekeeping gene as an intrinsic control in RNA extracted from nasopharyngeal swabs. The assay provides sensitivity and time to results similar to qRT-PCR testing.

Key Benefits

• Highly sensitive, fast and cost-effective high throughput kit for widely available Sanger sequencing equipment
• Enables each ABI 3730xl sequencer to process more than 2 000 samples per day
• Detects two highly specific N gene fragments of the SARS-CoV-2 viral genome
• High performance: limit of detection is 5 copies/reaction
• RUO version is already available, CE-IVD marking coming soon; the assay will be submitted to the US FDA for Emergency Use Authorization

Automated RNA Extraction

The GSD NovaPrime® IVD RNA Extraction AE1 and AE2 kits are an automated, magnetic bead extraction method for the isolation of high-quality RNA from clinical swab samples. The automated workflows have been optimized for an efficient and reliable process which ensures the removal of potential inhibitors from sample matrices. The kits are ideal for use with the GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR clinical IVD assay for virus detection.

ELISA Assays

We offer multiple immunoassays for antibody detection to SARS-CoV-2 with very good sensitivity and specificity. Antibodies testing provide information about past exposure to SARS-CoV-2. Coronavirus antibody tests could help identify donors of plasma from recovered patients that can be transfused into COVID-19 patients as a potential treatment, and can be used for serosurveys to evaluate the percentage of the population exposed to the virus.

A new CE marked serological assay is launched for the identification and quantification of antibodies to SARS-CoV-2. This ELISA kit can support vaccination campaigns by confirming the success of a vaccination and monitoring the antibody levels over time.

GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG NEW!

• Quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein
• Trimeric SARS-CoV-2 Spike antigen
• Intended as an aid to evaluate patients immune status and determine vaccine efficacy
• Calibrators correlate to First WHO International Standards for SARS-CoV-2
• Diagnostic sensitivity and specificity of 99.94% and 99.49% respectively
• Validated for serum, plasma, and finger prick (serum from capillary blood) samples
• CE-IVD

Key Benefits of Serological Assays

• Separate detection of IgG, IgA, and IgM antibodies to SARS-CoV-2 (NovaLisa®, VIROTECH, GSD ELISA Assays)
• A valuable tool to assess the immune response of the patient during and after the infection
• Ease of use on any open ELISA automation platform
• CE-IVD. Submitted to the US FDA for Emergency Use Authorization
• Total antibody detection ELISA assay to detect all isotypes (IgG, IgM and IgA) in a single sample: INgezim COVID 19 DR

Rapid Antibody Tests (Lateral Flow Devices)

The INgezim® COVID 19 CROM total antibody detection lateral flow devices, or rapid tests, determine past exposure to the virus in just 10 minutes. The serology-based, finger-prick tests are dual-recognition immunochromatographic assays that determine the presence of total antibodies (IgG, IgA, and IgM) specific to SARS-CoV-2 in a single blood, serum, or plasma sample, with high sensitivity and specificity (see details on product pages).

Key Benefits

  •  Results in only 10 minutes
  •  Test kits include all materials required to perform the test (test strip, lancet, pipette and diluent)
  •  Finger-prick blood extraction
  •  CE-IVD marked

Register and order our COVID-19 testing kits online!

Visit this page to browse our environmental surface testing kits!

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