Facilitating Fast and Reliable SARS-CoV-2 Testing Around the World
The COVID-19 outbreak has greatly impacted our society and economy – putting our health, peace of mind, and global stability at risk.
Recognizing the magnitude of this crisis, CENTOGENE has rapidly responded, developing - together with the partnering physicians of the Dr. Bauer Laboratoriums GmbH - a fully validated SARS-CoV-2 RT-PCR Test to prevent a further virus outbreak and help individuals who may not otherwise have access to testing. With tests being performed under the responsibility of our partnering physicians from Dr. Bauer Laboratoriums GmbH using resources of our ISO 15189 accredited laboratories, and patient data privacy ensured by using state-of-the-art security mechanisms, CENTOGENE offers complete assurance and peace of mind as a partner of choice.
Key Test Features
Fully validated SARS-CoV-2 RT-PCR Test
Emergency Use Authorisation by the US Food and Drug Administration
Rapid turnaround time - optional Fast Track Report at Frankfurt Airport
The Coronavirus disease (COVID-19) is an infectious disease caused by a virus called SARS-CoV-2 which first appeared in China in December 2019. 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.
Early detection of SARS-CoV-2 is vital in providing the best care possible to patients and contact persons preventing further spreading of this highly contagious virus.
2. Sample is taken
3. Sample is analyzed at CENTOGENE, and the result report is provided through via the online portal
About the Test
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, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.
The results are used to identify SARS-CoV-2 RNA, which is usually detectable in oropharyngeal samples during the acute phase of the infection.
The SARS-CoV-2 RT-PCR assay targets two specific regions of the SARS-CoV-2 virus genome to guarantee unequivocal detection of the virus:
- Positive (Detectable) Test Result - Amplification of both targets results reflects presumptive positive (detectable) test result. Positive results indicate the presence of SARS-CoV-2 RNA, and clinical correlation with patient history and other diagnostic information is highly recommended to determine the patient's infection status.
- Negative (Non-Detectable) Test Result - Amplification of neither target reflects a negative (non-detectable) test results. 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.
Validation process in accordance with the SARS-CoV-2 RT-PCR assay
- Highest reproducibility of results for a viral RNA-based positive control within (intra) runs and between (inter) runs.
- Highest reproducibility of negative control QC (negative and no template controls).
- Consistency of results for positive samples as verified by external laboratories.
- Highest reproducibility of results over time after sampling (0-72 h).
- Highest reproducibility of positive samples (>98.9%) by using CentoSwab™ up to 72 h at 2-8°C after sampling.
- CentoSwab™ is manufactured by our ISO 13485 certified partner RoweMed AG.
Accreditation of SARS-CoV-2 RT-PCR Testing provided by our laboratory partner Dr. Bauer Laboratoriums GmbH
The SARS-CoV-2 RT-PCR Testing is provided under the responsibility of the physicians at our laboratory partner Dr. Bauer Laboratoriums GmbH, which are using CENTOGENE’s established resources:
- CENTOGENE is CAP and CLIA accredited, ISO 15189 certified; the biorepository is CAP accredited.
- The SARS-CoV-2 RT-PCR test has received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).
- CENTOGENE's laboratory fulfills the EU guidelines for in-vitro-diagnostics (IVD) adhering to extensive interlaboratory comparison testing.
- External concordance testing by Charité University Clinic - Berlin, Germany (reference lab according to WHO) has taken place.
- External quality assurance was carried out under the guidelines of INSTAND e.V. for SARS-CoV-2 testing with inactivated positive and negative proband material.
All COVID-19 tests currently fall under EU regulations for IVD. According to this guideline, all suppliers of COVID-19 tests can self-certify their tests as IVD and do not need external approval.
Your End-to-End Solution
The COVID-19 RT-PCR testing is intended to be used by qualified and trained laboratory personnel who are specifically instructed and trained in the techniques of real-time RT-PCR and who meet the CLIA requirements of high complexity testing personnel.
Webinars on COVID-19 Testing Solutions
La nueva normalidad en la pandemia de SARS-CoV-2: contribuciones de un laboratorio de diagnóstico de alta complejidad
Mira nuestro webinar, donde Pilar Guatibonza, MD, nos habla de cómo CENTOGENE ha establecido con éxito un laboratorio para la detección de SARS-CoV-2 y ha desarrollado una prueba de alta calidad y alto rendimiento.
The New Normal Amid the SARS-CoV-2 Pandemic: Contributions From a High-Complexity Diagnostic Laboratory
Watch the webinar to learn how CENTOGENE successfully set up a SARS-CoV-2 detection laboratory and overcame the logistics and obstacles of developing a high-throughput, high-quality diagnostic test.
The SARS-CoV-2 RT-PCR test is intended for use only under the Food and Drug Administration’s Emergency Use Authorization and is only allowed to be performed within a CLIA high-complexity lab and by specifically trained personnel.