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.

COVID-19 products are not available in the U.S.

 

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.

Multiplex RT-PCR Respiratory Panel

SARS-CoV-2, Influenza A & B, and RSV A & RSV B NEW! 

Respiratory diseases caused by SARS-CoV-2, RSV, and Influenza virus have similar first clinical symptoms, and accurate identification is crucial for better patient care.
The Mplex SARS-CoV-2+, Flu A, Flu B (C1) RT-PCR assay allows to differentiate in a single reaction between Influenza A and B, and simultaneously detects two independent gene targets in SARS-CoV-2 (N-gene + RdRP-gene). In addition, the RSV A, RSV B RT-PCR assay is capable of differentiating between respiratory syncytial virus A and B.

Key Benefits

  • Both assays can be processed in parallel in the same plate using the same temperature profile
  • Validated sample material: nasopharyngeal wash/swab, oropharyngeal swab, nasal wash/swab
  • RNaseP used as internal control for sample quality, RNA extraction, and detection of inhibitors
  • Fast and reliable results in approximately 1 hour
  • CE-IVD

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

GSD NovaType IV SARS-CoV-2 NEW - detecting Omicron variant too!

GSD NovaType IV is a rapid and reliable RT-PCR assay for the differentiation of Omicron from other VOCs (Beta, Gamma, and Delta). The assay specifically identifies S gene mutations K417N, E484K, and L452R. Screening for S gene mutations K417N and L452R allows for active surveillance of variants Omicron and Delta, respectively.

GSD NovaType Detect&Select K417N SARS-CoV-2  NEW - detecting Omicron variant!

The new GSD NovaType Detect + Select K417N SARS-CoV-2 assay is designed for the simultaneous qualitative detection of SARS-CoV-2 genomic RNA and identification of the spike (S) mutation K417N in one reaction, in order to detect the Omicron variant of concern.

Key Benefits

  • Identification of SARS-CoV-2 N gene (targets: N1/N2) and mutation K417N in one reaction
  • Specimen types: nasal wash/swab, nasopharyngeal swab, oropharyngeal swab
  • RUO

GSD NovaType II Detecting Omicron variant too!

GSD NovaType II is a RT-PCR assay detecting the Omicron SARS-CoV-2 variant, including both sublineages of this mutation. GSD NovaType II SARS-CoV-2 specifically identifies mutations N501Y and K417N, present in Omicron in approximately 1 hour, much faster than genome sequencing methods. The assay is CE-marked and available immediately.

GSD NovaType II SARS-CoV-2 supplements the product range developed in response to emerging SARS-CoV-2 variants, such as GSD NovaType Detect & Select K417N SARS-CoV-2 (RUO), that combines SARS-CoV-2 detection and identification of an Omicron signature mutation in one reaction.

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; Omicron detection
  • Validated specimen types: nasal, nasopharyngeal, oropharyngeal
  • Fast and reliable results with very high sensitivity
  • CE-IVD

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

 

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

 

Visit this page to browse our environmental surface testing kits!

 

 

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