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. The rapid emergence of new virus variants represents a continuous challenge and underlines the need to identify, trace and track mutations.

Real-Time RT-PCR Kits for Detection and Identification of Variants

GSD NovaType Select SARS-CoV-2 Assay Family NEW! 

GSD NovaType Select is a group of RT-PCR assays to discriminate variants of the SARS-CoV-2 virus. This assay family provides the opportunity to assemble a customized RT-PCR assay mutation panel from a basis kit including the enzyme mastermix, and a range of mutation specific sets including primer, probes and controls.

The Select assays detect the following mutations: K417N, K417T, L452R, T478K, E484K, P681R, P618H.

Key Benefits

  • Customized assay set-up: choose from the NovaType Select assay panel the mutation combination
    (Base assay+Select assay of choice) that best fits your testing purposes
  • Parallel discrimination of most relevant mutations in S gene
  • Specimen types: nasal lavage/smear, nasopharyngeal lavage/smear, oropharyngeal swab

GSD NovaType III SARS-CoV-2 

The GSD NovaType III SARS-CoV-2 RT-PCR is developed for the rapid detection of SARS-CoV-2 variants of concern including B.1.427 / B.1.429 (Epsilon) / B.1.617.2 (Delta), B.1.617.1 (Kappa)/B.1.617.3, B.1.351 (Beta)/ P.1 (Gamma). The assay is intended as a confirmatory test for potential mutants and should only be performed after first testing patient specimens for the presence of SARS-CoV-2 RNA with a CE-IVD marked screening assay such as the GSD NovaPrime^® SARS-CoV-2 (COVID-19) RT-PCR kit.

Key Benefits

  • Parallel discrimination between S gene 484 wildtype (E484) and mutations E484K, E484Q and L452R
  • Specimen types: nasal lavage/smear, nasopharyngeal lavage/smear, oropharyngeal swab
  • CE-IVD

GSD NovaPrime^® Plus SARS-CoV-2 

The CE-marked GSD NovaPrime^® Plus SARS-CoV-2 is a new Multiplex Real-Time RT-PCR assay intended for the qualitative detection of SARS-CoV-2 and the simultaneous discrimination of B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.1.248 (P.1) (Gamma) lineages in one reaction.

Key Benefits

  • Detection of N501Y and/or E484K mutations in the spike protein
  • Specimen types: nasal, nasopharyngeal, oropharyngeal
  • Internal positive control to monitor successful extraction and amplification of sample material

GSD NovaType II

GSD NovaType II SARS-CoV-2 qPCR allows for the qualitative detection and discrimination of the SARS-CoV-2 S gene variants wildtype, and mutations K417N (specific to B.1.351, Beta), E484K and N501Y (common to most VOC). 

The assay is intended as a confirmatory test for potential mutants and should only be performed after first testing patient specimens for the presence of SARS-CoV-2 RNA with a CE-IVD marked screening assay such as the GSD NovaPrime^® SARS-CoV-2 (COVID-19) RT-PCR kit.

Key Benefits

  • Parallel discrimination between S gene wildtype and mutations N501Y, E484K, and K417N
  • Validated specimen types: nasal, nasopharyngeal, oropharyngeal
  • Fast and reliable results with very high sensitivity
  • CE-IVD

Real-Time RT-PCR Kits 

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 of SARS-CoV-2 genomic RNA in respiratory samples.

Key Benefits

  • Simultaneous detection of two target sequences in the N gene
  • Approximately 1 hour turnaround time
  • Specimen types: nasal wash/swab, nasopharyngeal wash/swab, oropharyngeal swab,
    BAL, pharynx gargle solution, and saliva.
  • Excellent performance with a 100 % NPA, PPA
  • Extraction/inhibition control included
  • CE-IVD

Real-Time RT-PCR Direct Kit

GSD NovaPrime SARS-CoV-2 Direct RT-PCR 

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.

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

Antigen Rapid Test

The GSD NovaGen SARS-CoV-2 Ag is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid (N) Protein antigens present in respiratory samples.

Key Benefits

  • Current mutant strains can be detected (UK, South Africa, Brazil)
  • Easy specimen collection: nasal and nasopharyngeal swabs
  • Fast results in 15 minutes
  • High sensitivity and specificity
  • CE-IVD marked

Sanger Fragment Length Analysis Kit

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 

• 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

The INgezim^® COVID 19 SPIKE CROM is a double recognition immunochromatographic assay capable of detecting specific antibodies against SARS-CoV-2 S protein in vaccinated individuals, in serum and blood samples with high sensitivity and specificity (see details on product pages).

Key Benefits

  •  Results in only 15 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!

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