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Vaccination Protection & Recovery

NEW

COVID-19

ANTIBODY TEST

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INFECTION DIAGNOSTICS

NEW: Our SARS-CoV-2 / COVID-19 ELISA Kit  

Coronaviruses were first discovered in the mid-1960s. In general, they can either only infect humans or only animals and contribute to causing colds in humans. However, coronaviruses, which previously only infected animals, can rarely spread to humans, spread further there and also lead to serious illnesses. In the past, this has been the case with the SARS-CoV (Severe Acute Respiratory Syndrome) and MERS-CoV (Middle East Respiratory Syndrome) outbreaks. Now it is the same with the novel coronavirus (SARS-CoV-2).

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A novel coronavirus (nCoV) is a new strain of the virus that has not yet been identified in humans - just as the now circulating coronavirus was described as new by Chinese authorities in early January 2020. According to virologists, the novel coronavirus SARS-CoV-2 is a variant of the SARS pathogen from 2002.

 

Since February 11, 2020, the novel coronavirus, which was provisionally referred to as 2019nCoV, has had a new name: SARS-CoV-2. SARS stands for "Severe Acute Respiratory Syndrome". The disease caused by SARS-CoV-2 is called Covid-19 (Corona Virus Disease 2019).

SYMPTOMS

Most common symptoms of infection with the SARS-CoV-2 coronavirus  

After being infected with the SARS-CoV-2 coronavirus, it takes an average of five to six days for the first symptoms of COVID-19 to develop.  The most common symptoms are cough, fever and runny nose. According to the Robert Koch Institute (RKI), coughing occurs in 42% of the COVID-19 cases recorded in Germany. More than a quarter of those affected have a fever. A runny nose is also reported by almost a third of those infected. Other symptoms such as sore throat, shortness of breath, headache and body aches as well as general weakness can also occur. Other organ systems such as the cardiovascular system, nervous system, liver and kidneys can also be affected.

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SARS-CoV-2 / COVID-19 ELISA KITS

High overall sensitivity and specificity

Our antibody tests for COVID-19, which include the detection of IgG, IgA and IgM antibodies against SARS-CoV-2-specific epitopes, are an important tool for documenting past confirmed SARS-CoV-2 infections as well as for detection a suspected past COVID-19 illness.  In addition, the measurement of SARS-CoV-2 antibodies can offer a prognostic value and provide information about the protective immunity in vaccination attempts.

IgM is the first immunoglobulin produced in response to an antigen and is primarily detected during the early onset of the disease. 

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IgG, on the other hand, is the most common immunoglobulin produced in response to infection. IgG often remains in the body for a long period of time.  Specific IgM and IgA is the early antibody response that begins within 3-5 days and peaks as it progresses.  Specific IgG antibodies are increased after about 10 to 18 days and then accepted as protective antibodies.

The antigen used to detect the antibodies in the patient's serum is the complete SARS-CoV-2 spike protein. The Anti-SARS-CoV-2 ELISA IgG / IgA is an IVD for the qualitative determination of Anti-SARS-CoV-2 specific IgG or IgA in human serum or plasma. 

SPECIFICATIONS FOR THE ANTI-SARS-CoV-2 ELISA

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Specifications for the Anti-SARS-CoV2 ELISA

  • All of the SARS-CoV-2 spike protein is used

  • Results can be positive or negative

  • Test duration ≈ 2h (30min / 30min / 20min)

  • 10μL serum or plasma per determination

  • Proof: HRP / TMB

 

The Anti-SARS-CoV-2 ELISA IgG / IgA can be carried out manually or fully automatically and is only used by qualified and trained specialists.

The comparison of different batches of the same Antibody classes with the same specificity is supported by the use of the international WHO standard for anti-SARS-CoV-2 immunoglobulins (spike protein).

In an evaluation, the overall sensitivity and specificity (compared to a commercially available anti-SARS-CoV-2-IgG ELISA) were determined to be 91% and 93%, respectively. For anti-SARS-CoV-2-IgA, the overall sensitivity and specificity (compared to a commercially available anti-SARS-CoV-2-IgA ELISA) were determined to be 92% and 93%, respectively .

ANTI-SARS-CoV-2 LFA IgG

Rapid test for the qualitative determination of anti-SARS-CoV-2 specific IgG in human serum or plasma

Antibody tests for COVID-19 include the determination of IgG, IgA and IgM antibodies against SARS-CoV-2-specific epitopes. They can be an interesting tool for documenting previous SARS-CoV-2 infections, both for patients with suspected COVID-19 symptoms and for patients with long-term complications who did not have a clear PCR test. In addition, the determination of SARS-CoV-2 antibodies can offer a prognostic value and provide information about protective immunity after a vaccination.

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SPECIFICATIONS Anti-SARS-CoV2 LFA

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The Anti-SARS-CoV-2 LFA IgG is an IVD for the qualitative determination of Anti-SARS-CoV-2 specific IgG in human serum, plasma and whole blood. The test helps to give an indication of a past infection with SARS-CoV-2 or to prove a vaccination success.  

Anti-SARS-CoV2 LFA specifications

  • Test result within 20 minutes  

  • All of the SARS-CoV-2 spike protein is used

  • Result can be positive or negative

  • 10µL serum, plasma or whole blood per determination

Anti-SARS-CoV 2 LFA IgG: REF 188010

Anti-SARS-CoV 2 LFA IgG: REF 188010

 

For testing, the sample material is placed in the sample application area of the Basis Set and the anti-SARS-CoV-2 buffer solution is dripped on directly afterwards. During the incubation time of 20-25 min , the liquid is drawn through the test unit due to capillary forces. The IgG antibodies in the sample are bound by an antibody that is linked to colored particles (conjugate). The complex of anti-SARS-CoV-2 IgG antibody and conjugate is specifically retained on the test line (T) via the complete SARS-CoV-2 spike antigen. The color intensity on the test line is proportional to the amount of immune complexes made up of specific IgG antibodies and conjugate. The signal intensity ranges from light pink to dark red. Unbound conjugate is retained on the control line (C) and forms a dark red line within the incubation period. The test can be read visually, reading with a dedicated electronic reading device (LFA reader) is recommended.

 

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