Expanded Range of COVID-19 Testing Methods for Clinical Trials Announced
Jun 01 2020
Laboratorium für Klinische Forschung, a member of GBA Group Pharma, is offering an analytical method for detecting SARS-CoV-2 from nasopharyngeal swabs. This has enabled the company to significantly expand its existing range of COVID-19 testing methods for clinical trials. Based on a Roche LightCycler 480 II, which uses the technique of real-time PCR (polymerase chain reaction), LKF can now perform numerous molecular biological applications (DNA or RNA analyses). The detection of the RNA of the SARS-CoV-2 virus is a prerequisite for the diagnosis of an acute infection with the new corona virus causing the disease COVID-19.
Founded in 1991, the LKF is a specialised medical laboratory for the support of clinical studies of Phases I-IV. Recently, it has established and validated specific analytical methods for the qualitative detection of SARS-CoV-2 in upper respiratory tract samples. The analytical method used is approved in Europe and in the USA as an in vitro diagnostic (IVD) kit and has also been internally validated.
The LKF offers a variety of test methods for the detection of anti-SARS-CoV-2 antibody tests, which can be used to determine whether a patient has already had contact with SARS-CoV-2: IgM and IgA antibodies for the first reaction of the immune system to a SARS-CoV-2 infection and IgG antibodies for the secondary antibody reaction that builds up long-term immune protection. Other tests are expected to follow immediately, such as the latest Elecsys® test from Roche, as soon as it becomes available in Europe.
The company is also involved in the development of COVID-19 drugs and currently supports multiple clinical trials testing new drugs for the treatment of COVID-19. “With our comprehensive test method panel for the quantification of inflammation markers (e.g. cytokines, procalcitonin) on various analytical platforms (e.g. Roche e501, Mesoscale Discoveries Multiplex Assays), we are well equipped for COVID-19 studies,” said Bärbel Wilke, co-founder and CEO of LKF - Laboratorium für Klinische Forschung (Laboratory for Clinical Research). “All services are carried out in-house, which guarantees a professional, flexible and rapid approach. This enables the LKF to set up a COVID-19 study within one week from the receipt of the clinical study protocol to the delivery of the laboratory kits to the intensive care units.”
“The corona virus pandemic makes the conduct of clinical studies very complex and leads to standstill in many places. We offer solutions for this,” continued Wilke. Wilke believes that corona testing could soon be a prerequisite for the inclusion and continued participation of patients in clinical trials. “By offering both molecular biological tests (PCR) for virus detection and general antibody testing, we are the optimal laboratory partner in the field of clinical trials. The state government has already recognised this and has declared the LKF to be a company of systemic importance.”
“In these difficult Corona times, a great deal of flexibility is required,” said Wilke. “But this is precisely one of our strengths - extreme flexibility. In this way we support our customers in pharmaceutical research in providing optimal care for patients and study participants and in advancing the development of important drugs.”
The following test methods are available at LKF: SARS-CoV-2 PCR on a Roche LightCycler 480 II platform; antibody tests for the detection of IgA, IgM and IgG from different manufacturers; immunological test procedures (ELISA, ECLIA, CLIA, immunoturbidimetry). All test methods have been approved by the FDA and the European authorities and are additionally validated internally at the LKF.
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