COVID-19: FAQ on Diagnostics, Imaging and Services

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 DNA from the 2019-nCoV virus in nasopharyngeal and oropharyngeal swabs from individuals with signs and symptoms of infection.
The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity². 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 test³ to detect the presence of SARS-CoV-2 antibodies in blood. The test, which is designed to detect both IgM and IgG, has demonstrated specificity of 99.8 percent and sensitivity of 100 percent at 14 days or more following a positive PCR test. This total antibody test will 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 acute patients (with active infection) 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 be diagnosed 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 diagnostics 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 are 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 help 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.

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 with CT and MR systems.
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 _{This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is 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 _{FTD SARS-CoV-2 Instructions for Use}

³ _{This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary from country to country and is subject to varying regulatory requirements.}

⁴ _{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.}