FDA: Laboratories are required to have the ability to detect 0.1ppb

In response to media reports that some scholars are concerned about the sensitivity of laboratory testing equipment for beta-receptor steroids (clenbuterol), the Food and Drug Administration of the Department of Health stated today on the 18th that the lower limit of the laboratory's quantitative testing range is usually required to be more than 3 times its detection limit and have appropriate accuracy and precision; that is, during certification, the laboratory will be required to have the ability to detect 0.1ppb, thus ensuring that 0.3ppb is a reliable quantitative limit value.

The Food and Drug Administration of the Department of Health stated that when certifying a laboratory, it will require the laboratory to have the ability to detect 0.1ppb.

The Food and Drug Administration of the Department of Health stated that the most sensitive liquid chromatography tandem mass spectrometer (LC/MS/MS) instrument is used to analyze the content of beta-receptor hormone (clenbuterol). When it is close to the background signal or limit, it is easy to have interference. Therefore, the lower limit of the laboratory quantitative test range is usually required to be more than 3 times its detection limit and have appropriate accuracy and precision. The current quantitative limit required by the laboratory is 0.3 for muscle tissue. ppb, so when the laboratory's test range for beta-receptor receptors in muscle is 0.3~500ppb, this bureau will require the laboratory to have the ability to detect 0.1ppb during certification, so as to ensure that 0.3ppb is a reliable quantitative limit value, because when making administrative penalties, it is necessary to base it on highly reliable data.

For the testing of beta-receptor (clenbuterol) content, in addition to using liquid chromatography tandem mass spectrometry (LC/MS/MS) in accordance with the testing methods announced by the Department of Health, the laboratory must also evaluate its ability to perform the test in accordance with the validation standards and quality control regulations announced by the Food and Drug Administration.

When a laboratory applies for certification from the Food and Drug Administration, it must provide relevant validation information to prove the correctness of the test results within a certain quantitative range, comply with the specifications and be reviewed and approved by an expert committee before it can obtain certification. The current limit of quantification required of laboratories is 0.3 ppb for muscle tissue. Compared with the international requirements for this test, this is the most stringent requirement with appropriate accuracy and precision.