In Vitro Diagnostic Reagents

The accuracy of in vitro diagnostic reagents is mainly guaranteed by strict production processes, quality control and calibration. Manufacturers must follow good manufacturing practices (GMP), use high-quality raw materials, and conduct multiple quality tests during the production process. At the same time, products must undergo rigorous clinical trial verification, and regular calibration and quality assessment must be performed to ensure the accuracy and reliability of test results.

The shelf life of in vitro diagnostic reagents varies depending on the product type. Generally speaking, the shelf life of biochemical diagnostic reagents is usually 12-24 months, the shelf life of immunodiagnostic reagents is mostly 12-18 months, and the shelf life of molecular diagnostic reagents may be around 6-12 months. However, the specific shelf life should be based on the product instructions.

Before use, check whether the packaging of the reagents is intact and whether they are expired, and confirm whether the model and specifications of the reagents are consistent with the test requirements. At the same time, prepare the required testing instruments and consumables, and calibrate and maintain the instruments according to the instructions. Operators also need to take personal protection, such as wearing gloves and masks.

First, confirm whether the test operation is correct, whether the reagents are within the validity period, and whether the instrument is operating normally. If the results are still abnormal after excluding these factors, the samples should be collected again for testing, or other testing methods should be used for verification. If there are still doubts about the results, you should communicate with the clinician in time and make a comprehensive judgment based on the patient's clinical symptoms and other test results.