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About the Coronavirus - COVID-19

The Coronavirus (COVID-19) is an infectious disease caused by the so-called SARS-CoV-2 virus and first appeared in China three months ago. In approximately 86% of all infected individuals, the infection is mild to asymptomatic (Ruiyun Li et al., Science, 2020). However, especially in older people with preexisting illnesses, the virus can lead to severe respiratory disease or even severe pneumonia.

Cases of the virus have been confirmed in all federal German states. Updated details are provided daily by the Robert Koch Institute or on the Worldometers website.



How Can I Protect Myself From Infection?

Currently, there is no vaccine or direct causal therapy. To prevent infection, thoroughly wash your hands regularly, cover your mouth with your elbow when sneezing or coughing, and carry out ‘social distancing,’ i.e., at least two meters between you and other individuals.

How Can I Get Tested?

The diagnosis of acute COVID-19 is established via a throat swab. This can be done by a healthcare professional or independently following simple video instructions. The sample is then taken to the laboratory, where the genetic information (RNA) of the virus is detected by means of so-called RT-PCR.

CENTOGENE offers COVID-19 diagnostic services to selected partners. The test is CE labeled (for internal use only).

Do You Have Further Questions?

If you have questions about registering for a COVID-19 test at CENTOGENE, you can reach us by email or by phone between 8:00 a.m. and 4:30 p.m.

Email: corona(at)centogene(dot)com
Phone: +49 381 80 113 700

On this page, we have provided instructions on how to register for the test and information regarding the receival of results, as well as informative videos on how the test is performed by healthcare professionals or by yourself.


Instructions for Test Registration

  • Guide to Testing for SARS-CoV-2 Virus RNA with CENTOGENE

    Download

How the Test is Performed

Getting Tested by a Healthcare Professional

Instructions for having a throat swab performed by a healthcare professional


Self-Administered Swab

Instructions for performing a throat swab by yourself


Intended Use

The SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of nucleic acid from SARS-CoV-2 in samples of the upper respiratory tract (oropharyngeal swabs) collected from individuals suspected by their healthcare provider to have Covid-19, individuals belong to a risk cohort or having been in contact with a confirmed Covid-19 patient. Testing is limited to Centogene AG, Rostock and Boston that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform highly complex testing.

The results are used to identify SARS-CoV-2 RNA. Sars-CoV-2 RNA is usually detectable in oropharyngeal samples during the acute phase of the infection.

The SARS-CoV-2 Real-time RT-PCR assay targets two distinct regions within the SARS-CoV-2 genome: E-Gene and RdRP-Gene. Amplification of both targets results in a presumptive positive (detectable) test result, while amplification of one of two targets results in an inconclusive result, and amplification of neither target results a negative (non-detectable) test result. Samples with inconclusive test results will be confirmed by a second PCR reaction for the RdRP Gene. Positive results indicate the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is highly recommended to determine the patient's infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Centogene AG is required to report all positive results to the appropriate health authorities.

Negative results do not rule out SARS CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

The COVID-19 RT-PCR testing is intended to be used by qualified and trained laboratory personnel specifically instructed and trained in the techniques of real-time RT-PCR and meet the CLIA requirements of high complexity testing personnel. The testing is limited to “CENTOGENE Diagnostic Laboratories or other laboratories designated by CENTOGENE that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.”

The SARS-CoV-2 RT-PCR test is intended for use only under the Food and Drug Administration’s Emergency Use Authorization.

Data Protection for COVID-19 Testing

CENTOGENE does not share any data with third parties (except for the legally required reporting of positive cases to the public health department). The data is processed exclusively in accordance with the consent of the test individuals. All personal data in our database from negatively tested individuals will be deleted after not accessing the data for three months, or in advance on request. All data is processed via an autonomous software application and stored in an encrypted database. CENTOGENE has a state-of-the-art IT infrastructure, which is regularly checked and secured for weak points and possibilities of unauthorized access by third parties. The underlying infrastructure is certified according to current IT security and data protection standards. The sample itself is stored for seven days after the test and then destroyed if the test was negative. Positive samples and related data in our database from tested individuals are stored for up to six months or longer if agreed upon by the individual, and in each case, in accordance with the currently applicable legal provisions.