In May of this year, German PEI published an article “Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests”, which evaluated the sensitivity of 122 COVID-19 antigen rapid test products that currently have CE certificates and are sold in Germany. . Due to changes in EU registration regulations and German financial policies, the purpose of this comparison evaluation is to confirm the sensitivity of existing products. Reagents that do not meet the minimum sensitivity requirements are removed from the BfArM list, and all evaluation results are released. On the PEI webpage. The assessment includes 62 Chinese companies.
Sample preparation: 3 concentration gradients
Ultra-high concentration-PCR CT value 17-25
High concentration-PCR CT value 25-30
Medium concentration-PCR CT value 30-36
CT value and RNA copy conversion ratio:
CT25 is about 10^6 RNA copies/ml, CT30 is about 10^4 RNA copies/ml, and CT36 is about 10^3 RNA copies/ml.
Minimum sensitivity standard:
The coincidence rate of samples with PCR CT value<25 is 75%
Not much to say, just go to the data.
Result 1: A total of 96 products meet the minimum sensitivity requirements, of which 48 are Chinese products. For the convenience of comparison, the results of “CT17-36″ are sorted from high to low.
Result 2: A total of 26 products do not meet the minimum sensitivity requirements, of which 14 are Chinese products. For the convenience of comparison, the results of “CT17-36″ are sorted from high to low.
Information source: medRxiv preprint doi: Https://doi.org/10.1101/2021.05.11.21257016
Post time: Aug-31-2021