Changed diagnostic layout of SARS-CoV2 PCR results

03.04.2020

from now on, we will only show positive or negative results on our reports.

Up to now you received two results depending on the test used.

If the sample was analyzed with the Roche method, we have given the results for both target sequences of the PCR (ORF1 and E gene) separately. The ORF1 gene is specific for SARS-CoV-2, while the E gene is also present in other corona viruses. The cases in which only the ORF gene was amplified have already been evaluated positively. Few cases with isolated positive E gene were classified as doubtful and therefore repeatedly led to queries and problems regarding the further management of affected patients. Taking into account the epidemiological situation and the overall increased positive rate, we are following the WHO recommendation with immediate effect and already issue a result as "positive" if only the E gene has been amplified. In order to simplify the findings, only one overall result (positive or negative) will therefore appear in the future. A result is positive if at least one of the two target sequences of SARS-CoV-2 was detected in the smear material.

If the sample has been analysed with methods from rBiopharm or TibMolbiol, we have so far performed separate screening and confirmation tests. Analogous to the procedure described above, due to the high positive predictive value with increasing COVID-19 prevalence, we limit ourselves to the previous screening test targeting the E gene.

Translated Version - Original Version here