In the field of in vitro diagnostics, the reagent instructions serve as a “guideline for action” that directs users on proper operation to ensure accurate and reliable test results. Among these, the description of instrument parameter configuration is a critical aspect. Today, we will delve into how to describe instrument parameter configuration in the instructions for in vitro diagnostic reagents.
1. Importance of Clearly Describing Instrument Parameter Configuration
The use of in vitro diagnostic reagents often relies on the cooperation of instrument equipment, and the accurate setting of instrument parameters directly affects the accuracy and stability of test results. If the description of instrument parameter configuration in the instructions is vague, users may encounter deviations in test results due to improper parameter settings, which can subsequently impact disease diagnosis and treatment decisions. A detailed and accurate description of instrument parameter configuration allows users to clearly understand operational key points, standardize operational processes, and ensure testing quality.
2. Key Parameter Description Requirements in the [Testing Method]
In the [Testing Method] section of the in vitro diagnostic reagent instructions, it is necessary to clearly define the key parameters of the testing process, main steps, and reaction system. These key parameters include, but are not limited to, sample processing conditions, reaction temperature, reaction time, reagent addition amounts, and instrument operating speed. For example, in the nucleic acid detection reagent instructions, it is essential to specify the temperature and time for sample nucleic acid extraction, as well as the denaturation temperature, time, annealing temperature, time, extension temperature, and time for each cycle during the PCR reaction; for immunoassay reagents, the temperature and time for antigen-antibody reactions, washing frequency, and time must be clearly defined. Only by presenting these key parameters clearly can users operate according to standard procedures and ensure the reliability of test results.
3. Key Points for Describing Parameters of Fully Automated Instruments
When the applicable instrument is fully automated, the instructions must also clearly specify the operational modes and key parameters related to testing in the applicable instruments, avoiding vague descriptions such as “for specific operational steps and parameter settings, refer to the instrument manual.” Although fully automated instruments have the advantage of high automation, there are differences in operational modes and parameter settings among different brands and models. If the instructions do not provide specific operational modes and parameters, users may find it challenging to determine which settings are suitable for the reagent when faced with multiple instruments, leading to operational errors.
For instance, a certain fully automated chemiluminescence immunoassay analyzer may have different operational modes, such as standard mode and rapid mode, when conducting tests for specific in vitro diagnostic reagents. The sample injection speed, reaction cup cleaning intensity, and detection signal reading time may vary under different modes. The instructions should detail the applicable operational modes for the reagent and specify the exact values or ranges of each key parameter under that mode, making it clear for users.
4. Significance of Standardized Descriptions
Standardizing and detailing the description of instrument parameter configuration is not only for the convenience of user operation but also for the responsibility towards patients. Accurate instrument parameter settings can ensure the consistency and accuracy of test results, aiding doctors in making correct diagnoses and treatment plans. Additionally, this reflects the professionalism and rigor of the in vitro diagnostic reagent manufacturing companies, enhancing the credibility and competitiveness of the products.
The description of instrument parameter configuration in the in vitro diagnostic reagent instructions may seem like a detail issue, but it is of great importance. Only by strictly adhering to the requirements and presenting the instrument parameter configuration clearly and accurately can in vitro diagnostic reagents maximize their value in clinical applications, providing strong support for safeguarding people’s health.