Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit¹
What kind of test is it?
The molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. The real-time PCR test is intended for the detection of the RNA from the SARS-CoV-2 virus in upper respiratory specimens (such as nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage (BAL) from individuals with signs and symptoms of infection.
The test has shown 100% (91.8-100, 95% CI) positive percent agreement and 100% (88.7-100, 95% CI) negative percent agreement². Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. Test kits are available in different quantities, allowing to analyze 30 or 94 patient samples per kit.
Antibody test
What are the designed features of the Siemens Healthineers COVID-19 antibody test?
Siemens Healthineers has developed a laboratory-based total antibody test¹ to detect the presence of SARS-CoV-2 antibodies in blood. The test, which is designed to detect both IgM and IgG, has demonstrated negative percent agreement (specificity) of 99.8 percent and positive percent agreement (sensitivity) of 100 percent at 14 days or more following a positive PCR test. This total antibody test may provide a clearer view of patients’ disease progression by identifying individuals who are still potentially infectious with the virus and individuals who have developed an immune response to the virus, even if they were asymptomatic or never diagnosed with the disease.
What are the benefits of such a total antibody test?
A total antibody test (which includes detection of IgM and IgG) designed with outstanding specificity and sensitivity offers three distinct pieces of information:
• High specificity aids in identifying patients that are still at risk for infection.
• High sensitivity maximizes detection of potentially recently-infected patients when used in conjunction with PCR testing.
• High sensitivity also helps identify individuals who have developed an immune response to the virus, even if they were asymptomatic or never diagnosed with the disease
Blood gas analyzer
How do blood gas analyzers contribute to the fight against COVID-19?
Blood gas analyzers are crucial for the diagnosis and monitoring of critically ill patients in intensive care units, operating rooms and emergency rooms. For patients who need to be ventilated due to severe COVID-19 disease, blood gas analyzers measure oxygenation levels of the patient’s blood. Based on these results, nurses and physicians adjust ventilator settings or other necessary treatments.
Computed Tomography
How can computed tomography (CT) help in detecting COVID-19?
Computed tomography plays an important role in both the diagnosis and monitoring of COVID-19. CT images of the chest provide important information about the patient's health and the effectiveness of therapies. Virally acquired pneumonia, such as COVID-19, can be characterized by different patterns of changes in the lungs and their localization.
Which pathological changes are visible on a thoracic CT/lung CT of a COVID-19 patient and at which stage of the disease?
CT images of the thorax show characteristic signs of viral pneumonia already at an early stage of the disease. These include, for example, so-called ground glass opacities or consolidations, characterized as extensive brightening of the lung. In addition, CT plays an important role in monitoring the progression of the disease, especially in patients with acute or imminent lung failure.
Siemens Healthineers provides CT scanners as container solutions. How do those help hospitals cope with this pandemic?
The container solutions allow clinics to examine patients before they are admitted to hospital. They make it easier for hospitals to examine infected and non-infected patients separately, thus ensuring additional hygiene safety. The CT scanners of the Somatom go platform can be operated wirelessly via tablets, thus enabling the necessary distances to be maintained to further protect medical personnel when preparing patients for the CT scan.
Due to their compact dimensions and low dissipated heat levels, the flexible Somatom go systems are particularly suitable for use in containers. Such mobile CT solutions from Siemens Healthineers have already proven themselves in several countries, including Austria, China, Germany, Poland, Portugal, and the United Kingdom, to build up the much-needed scanning capacities in the current situation.
Ultrasound
How can ultrasound help in the diagnosis and treatment of COVID-19?
The ultrasound scan can reveal abnormalities on the lung surface. A pneumonia that extends to this pleural surface may aid in diagnosis using pulmonary ultrasound. COVID-19 tends to affect the terminal alveoli in the peripheral area of the lung. Lesions tend to be close to the pleura, which is exactly where ultrasound works best. In addition, ultrasound imaging offers the great advantage of mobility, since it can be performed directly at the patient's bedside and the patient does not have to be transported to another treatment room for this purpose. This is a great advantage especially for COVID-19 patients who may be in a very critical condition and may depend on artificial respiration.
What is the difference between CT and ultrasound in terms of knowledge gain?
Due to its high sensitivity, CT is currently the imaging method of choice for diagnosing and monitoring patients with COVID-19. However, chest CT can be difficult for patients with hypoxemia and hemodynamic failure. On the other hand, due to the air in the lungs, the return signal of the ultrasound may be blocked, which makes deeper, pathological changes difficult to detect. However, in recent years it has been ascertained that ultrasound artifacts can show different patterns with different lung diseases and that this can assist in the case of COVID-19 to help diagnose the state/phase of the disease. In order to enhance the diagnostic possibilities, both procedures should be used together.
When would a COVID-19 patient have a CT scan and when an ultrasound scan?
A thoracic CT is not suitable for all patients, for example patients with a lack of oxygen in the blood, pregnant women or COVID-19 patients with particularly severe symptoms for whom transport would be difficult.
X-ray
How can (mobile) X-ray systems help with diagnose and treatment of COVID-19?
X-ray systems especially help with the initial diagnosis of the severity of existing lung damage caused by COVID-19 and its follow-up. Chest X-rays can show characteristic signs of viral pneumonia. These include, for example, so-called ground-glass opacities or consolidations, which are shown by patchy shadows in the lungs. Mobile X-ray systems can also help with the follow-up on particularly severe cases, since the device is driven to the patient in the intensive care unit for example, and the patient does not have to be transported through the hospital effortfully.
Services and training3
How does the COVID-19 pandemic impact service response times?
Siemens Healthineers has invested in IT infrastructure, a smart remote service network, and three remote service centers, that can serve healthcare providers worldwide around the clock. This technology for example allows to remotely support CT and MR systems.4
This is complemented by our worldwide logistics organization. Here, too, we have taken precautions by timely replenishing supplies in our global warehouses.
How do you provide training for your systems?
Training documents and video tutorials are available online on our training platform PEPconnect. Among other things, it provides instructions for disinfecting equipment or special rules of conduct for clinical staff. Medical staff can also learn how to support each other remotely with dedicated remote maintenance software. The platform PEPconnect also includes free COVID-19-specific online trainings.
Are you still providing services and maintenance on-site?
Remote is the preferred way of providing service and maintenance. We still visit our customers on-site when, for example, an X-ray tube must be replaced in a CT scanner.
1 These tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA for use by authorized laboratories. The molecular (“PCR”) test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology (“antibody”) test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. Both tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.
2 Performance claims are based on use of the FTD SARS-CoV-2 assay with NucliSENS® easyMAG® / Applied Biosystems® 7500 using nasopharyngeal swab specimens. See FTD SARS-CoV-2 Instructions for Use (11416299_en).
3 The products/features and/or service offerings (here mentioned) are not commercially available in all countries and/or for all modalities. If the services are not marketed in countries due to regulatory or other reasons, the service offering cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.
4 Connection to Smart Remote Services (SRS) infrastructure is required.
This FAQ as well as press releases, press images and other material are available at https://www.siemens-healthineers.com/press-room/press-features/pf-covid-19.html. Further information on COVID-19: https://www.corporate.siemenshealthineers.com/covid-19.
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
