Nowadays, more and more in vitro diagnostic reagents come into family life, such as early pregnancy test and blood glucose monitoring. This kind of application brings many differences in understanding and problems in use. There is a great demand for popularization of knowledge in the aspects of product safety, storage, inspection and its use. Popularization of science is becoming more and more necessary. Today, Desheng edited some popular science knowledge, which will be displayed in the form of question and answer for everyone to learn.
What are the main aspects of the safety of in vitro diagnostic reagents?
A: in vitro diagnostic reagents are used to diagnose whether patients or examinees contain certain infectious factors or whether certain functions of the body are normal, so the reagents themselves need to be safe and non infectious. In order to protect personnel from infection of positive substances when using in vitro diagnostic reagents, all materials containing infectious factors should be inactivated before use.
In order to protect the operators from damage, the containers of each component of the kit should avoid using glass materials, plastic products should be used as far as possible, and metal aluminum covers should be avoided, instead of plastic materials. In the chemical reagent components, avoid the use of strong acid, strong base reagents.
What are the main forms of test results of in vitro diagnostic reagents?
A: at present, in vitro diagnostic reagents are used for testing, and the results are mainly reported in three forms:
One is qualitative test: the result is either "negative" or "positive". For example, if the test shows that HBsAg is positive, it means that there is hepatitis B virus in the patient's body.
Second, semi quantitative detection: it is mainly used to detect the titer, which is often used for antibody determination, such as antinuclear antibody 1:16, etc., which is a semi quantitative report form.
The third is quantitative detection: using specific numerical report (which is also the most frequent way on the inspection report at present). When you look at the report sheet that uses numerical value to report the test results, you must pay attention to the unit of measurement behind the item. Different units of measurement result in different data, sometimes thousands of times different. However, it should be noted that when judging the change trend of the test results of a certain index, we should not only look at the numbers, but also pay attention to the units. Only when the measurement units are the same, the results can be comparable.
3. What is the intended use of in vitro diagnostic reagents?
A: the intended use of in vitro diagnostic reagent products is generally approved by the food and drug administration, which is scientific and legal, such as "auxiliary diagnosis" and "diagnosis", "early diagnosis", "screening", "treatment monitoring", "individualized drug use" (accompanying diagnosis), etc. at the same time, quantitative or qualitative detection and sample type should be marked on the instruction manual What are the requirements.
I hope the popular science knowledge organized by Xiaobian today can help you learn better. Desheng is a professional manufacturer of in vitro diagnostic reagents. Its main products include chemiluminescent reagents, blood collection additives, biological buffers, chromogenic substrates, enzyme preparations, etc.
Contact Person: Miss. Ankiwang