Case Study

Three German Specialist Practices Report: LumiraDx SARS-CoV-2 Antigen Test Supports Established Testing Concepts with Rapid and Accurate Results

Medical Practice Dr. med. Tobias Koerner

After several years of medical training at various hospitals and medical work in traumatology, Dr. Koerner completed his training as a specialist in general medicine in 2012 and has been running his GP practice in Leipzig since 2016 with a current staff of eight employees. It is important to him to offer his patients the most comprehensive diagnostics and treatment possible with the help of outstanding medical expertise and the use of state-of-the-art technology, thus keeping waiting times and distances for patients as short as possible. Dr. Koerner is supported in this by two employed physicians, two medical students in advanced training and 4 nurses. In the foreground is also the medical education transfer. Thus, his practice is a teaching physician practice of the Leipzig University Medical Center and thus makes an important contribution to the best possible qualification of medical students.

"Our patients are our focus. For them, we want to keep waiting times and distances as short as possible. What helps us in achieving this is professional planning as well as state-of-the-art and digital technology for medical diagnostics including the LumiraDx Platform, which allows us to offer reliable and fast diagnostic results directly on the patient which flow seamlessly into our practice software."
-Dr. med. Tobias Koerner, Leipzig

The SARS-CoV-2 point of care testing concept

The practice offers an infectious disease consultation in a specially equipped consultation room, which is carried out every working day by a medical staff member in accordance with strict hygiene regulations. Patients with any kind of infection symptomatology are called in by telephone and given consent according to a strict schedule. A nasal swab is taken from the patients and they leave the practice immediately after the collection. In parallel, the collected patient sample is tested with the SARS-CoV-2 Antigen Test on the LumiraDx Platform. After a short time, patients receive a phone call informing them of their result. If the result is negative, patients can go about their daily lives or, if they wish, they can be transferred to the normal consultation hours for other diagnostics or treatment.1 Separate rooms and strict organizational planning allow the infectious disease consultation to be separated in terms of time and space from the actual practice. Only in the case of severely symptomatic patients, in whom there is also a concrete suspicion of COVID-19 disease, is a swab taken directly for PCR testing in the laboratory in some cases. The practice staff are also tested using the rapid test service at least once a week, to provide reassurance of their COVID-19 status. Since the introduction of the new test regulation on March 8, 2021, the practice now also offers regular and free rapid testing for patients without specific symptoms as part of the so-called "citizen testing" in Germany.

Why the LumiraDx SARS-CoV-2 Antigen Test?
"Testing with the SARS-CoV-2 Antigen Test gives our practice team an enormous sense of security. Highly sensitive antigen testing has become established in our practice, as negative test results have a very high probability of ruling out the risk of infection in both patients and staff. The quick and easy test procedure on the small LumiraDx Platform fits well into our practice workflow and our patients appreciate the short waiting times until their test result is available. In addition, we can also test other laboratory parameters on the device, such as INR and D-dimer. For us, a modern, tetherable point-of-care system that allows us to perform as many different high-quality tests as possible with short waiting times using patient-friendly sample types (e.g., nasal swab or capillary blood from the finger) is optimal."

Medical Practice Dr. med. Barbara Buchali

Dr. Buchali is a specialist in otolaryngology (ENT) and has been running her private practice in the center of Munich since 2007. Her many years of medical and surgical training in the clinic and the constant expansion of her expertise through further training and education, as well as her practical experience, enable her to assist her patients with extensive specialist knowledge. In addition, Dr. Buchali works as an expert physician and also holds additional qualifications in allergology, acupuncture, naturopathic treatment, hygiene medicine and expert in antibiotic stewardship. Another specialty of her work is also the diagnostics of the vestibular syndrome, which, in addition to the aforementioned specialties, she performs at the highest scientific level.

"Every patient who presents to my practice can potentially be SARS-CoV-2 infectious. That is why we follow a strict hygiene and rapid testing concept to protect patients and staff. This enables us to guarantee medical care throughout. With the LumiraDx SARS-CoV-2 Antigen Test, we have found a very good technical solution with high reliability, which is also very well received by patients, as a distinct result from a simple nasal swab is available on the high-tech device after only a short time."
-Dr. med. Barbara Buchali, München

The SARS-CoV-2 point of care testing concept

The private medical practice only offers appointment consultations and with that ensures a structured flow of patients. Adherence to strict hygiene rules and a physical separation of patients ensure maximum protection against infection. In principle, all patients are first classified as potentially infectious. They are given a measurement of their body temperature before entering the practice rooms. In addition, patients with any symptoms of infection will also have a swab taken for a SARS-CoV-2 Antigen Test on the LumiraDx Platform following an informed patient consent. The examination of potentially infected patients is always performed with full protective equipment in a treatment room separate from the normal consultation room. Dr. Buchali first performs the initial endoscopic examination and also takes a nasal swab sample, which is then taken and tested by a nurse. In the event of a positive result, a report is made to the public health department, a PCR confirmation test is arranged in the laboratory, and home quarantine or isolation is initiated immediately. In the case of a negative test result, the patient is classified as "non-infectious" for SARS-CoV-2.1

Why the LumiraDx SARS-CoV-2 Antigen Test?
"As a private medical practice, I can take a little more time for my patients to examine them comprehensively and provide them with informed, high-quality diagnostics and therapy. I specifically chose the LumiraDx Platform because I prefer a modern technical approach with corresponding precision and accuracy similar to that of a laboratory device for my practice. In contrast, the so-called lateral flow method unfortunately only insufficiently fulfills my quality criteria for rapid diagnostics. With these tests, the visual test line on the test cassette is often only indistinctly recognizable, which makes it difficult to correctly and reliably assign the result."

Medical Practice Dr. med. Rudolf Thiele

Dr. Rudolf Thiele has been a General Practitioner with his own practice since 2009 and previously worked as a physician for many years at the university hospitals in Heidelberg and Essen. He currently employs 7 staff members and besides his head practice in rural Modautal-Brandau he additionally runs a satellite practice. Dr. Thiele is supported in the care of his patients by two employed physicians, one of whom is a doctor in training, as well as by 5 nurses. Both for the care of patients and for the activity as an educational center for general medicine, the medical and technical know-how of the practice team is the focus of the daily work. The practice covers the entire spectrum of general medical diagnostics and therapy with the most modern equipment and thus ensures comprehensive, local medical care for patients in a rural region.

"For COVID-19 antigen testing as part of our testing concept, we focus on the quality of the tests. Compared to the simple lateral flow tests, we have chosen a point-of-care test with a low limit of detection and high overall accuracy. We rely on the active and precisely controlled test performance of the SARS-CoV-2 Antigen Test in the LumiraDx device, as its technology is based on the principles of laboratory analysers."
-Dr. med. Rudolf Thiele, Modautal-Brandau

The SARS-CoV-2 point of care testing concept

The practice offers its patients the opportunity to be tested for a possible SARS-COV-2 infection using the LumiraDx SARS-CoV-2 Antigen Test every working day. The tests are carried out as part of an infectious disease consultation for patients with any symptoms of an infectious disease after consent has been obtained and an appointment has been made by telephone. On behalf of the local authorities, the practice also provides weekly testing for teaching and educational staff. Following the example of a drive-in, a swab is taken from the persons while they are sitting in a car by a healthcare professional and tested directly in the practice using the SARS-CoV-2 Antigen Test on the LumiraDx Platform. Since the test result is available in less than 12 minutes, patients can wait in the car to be notified of the result. If the result is positive, a PCR test will be arranged in the laboratory for confirmation. Practice staff also undergo testing at least weekly to ensure maximum safety for the entire team.

Why the LumiraDx SARS-CoV-2 Antigen Test?
"Negative really is negative - after several months of experience with the LumiraDx SARS-CoV-2 Antigen Test, we have not yet had a single case in which a negative point-of-care antigen result could be assigned to an infectious event. This creates a lot of confidence in our point of care test concept and gives us confidence in treating patients as "test negative" after a negative antigen test result has been obtained. In addition, the ease of taking the nasal swab is much more comfortable for our patients compared to an uncomfortable nasopharyngeal swab. Our practice team was also impressed by the simple and intuitive use of the system - like a smartphone, the display of the test device guides the user step-by-step through the test procedure. We would like to see an expansion of available tests on the LumiraDx Platform, which we plan to use, for example, to support rapid differential diagnoses."

1. The LumiraDx SARS-CoV-2 Ag Test result should not be used as the sole basis for treatment or case management decisions. To confirm the infection status a clinical correlation of the test result with the individual’s history and other diagnostic information is necessary.
 
When testing with the LumiraDx Platform and SARS-CoV-2 Ag Test please study the LumiraDx Platform User Manual and LumiraDx SARS-CoV-2 Ag Test Strip Product Insert before performing a test.
 
The results shown here are specific to the health care facilities and may differ from those achieved by other institutions.

Copyright Pictures by Barbara Buchali, Tobias Koerner and Rudolf Thiele