Several studies show that ferritin levels are enhanced in COVID-19 patients. In some cases even strongly. Ferritin is an iron storage protein that is the main source of iron reserves in every cell. Measurement of the ferritin concentration in serum determines the total amount of iron [...]
Urine diagnostics is an essential part of the work in the medical laboratory. Urine values provide clues to medical findings. They help doctors diagnose diseases and treat patients properly. Our improved Duotrol® Urine Liquid Quality Control supports medical laboratories in daily urine diagnostics for the benefit of the patient. [...]
We proudly present our new ISO 13485 certificate. After successful audit by the British Standards Institution (bsi.) our ISO 13485:2016 & EN ISO13485:2016 certificate was successfully renewed. The certificate further certifies our ISO compliant actions in the manufacturing and distribution of in-vitro diagnostics (IVD). In line [...]
Following validation and verification, the quality standard of control results in laboratories is now also declining. This is stated in the essay "Diluting Quality Standards: Validation, Verification and now "Confirmation" by James O. Westgard and Sten A. Westgard from September 2020. The changes made by the [...]
"Are you addicted?" This is the title of Oswald Sonntag's report on independent quality controls and their significance in the magazine Trillium Diagnostik TD4/2019, starting on page 156. ISO 15189 indicates independent quality controls. The IVDR now also sets new standards for independent control material. Up [...]
Our well-established control for CSF diagnostics, Duotrol® CSF Liquor, is now reinforced by the new accuracy control Duotrol® CSQ Advanced, which replaces the previous Duotrol® CSQ Liquor. In addition to the standard parameters of CSF diagnostics, it offers values for ferritin in CSF for the detection of [...]
"Quick action is necessary", says an article on the effects of the IVDR regulation on medical laboratories by Dipl. Biol. Ulrich Hafen in edition 3/2019 of the journal Trillium Diagnostik. Medical laboratories that use their own "laboratory developed tests" (LDT), including their own software, are just as affected by the [...]
With "Duovid-19" BIOMED-Labordiagnostik GmbH establishes its first RNA control for monitoring and validation of common molecular diagnostic SARS-CoV-2 PCR tests on the market. The control is "for research use only". The highly infectious coronavirus SARS-CoV-2, which causes the novel disease COVID-19, can cause severe damage to [...]
