Simply put, in vitro diagnostic products refer to reagents, instruments, consumables, etc. that are used for in vitro detection of samples taken from the human body (such as blood, urine, cerebrospinal fluid, tissue fluid) to provide information for the diagnosis and treatment of diseases.
There are many types and varieties of in-vitro diagnostic products, including instruments and in-vitro testing kits for hospital laboratory, in-vitro diagnostic products also include blood glucose meters, blood glucose test strips, and early pregnancy test strips for home self-testing.
In vitro diagnostic products play an important role in the assessment of human health status, auxiliary diagnosis and treatment monitoring of diseases, and prevention and monitoring of public health emergencies.
The test information provided by in vitro diagnostic products accounts for more than 60% of all medical information such as diagnosis and efficacy of patients. It is difficult to imagine that doctors can successfully complete medical behavior without the information provided by in vitro diagnostic products.
"Are the results accurate?" is a common concern of patients after seeing the test sheet. Poor quality in vitro diagnostic products may detect pathological values in normal human samples.
Pathological samples may also be detected as normal values (that is, false negatives), which will lead to serious consequences such as misdiagnosis and treatment delays, and cause great economic losses, psychological burdens and physical pain to patients.
Taking in vitro diagnostic product early pregnancy test strips as an example, false negative results will make users mistakenly think that they are not pregnant, and may continue to smoke, drink, receive X-ray radiation, or take drugs that are not suitable for pregnant women, causing damage to the embryo. Likewise, false-positive results can cause physical and psychological harm to users and their families.
At present, everyone is generally concerned about "one-way inspection of test results", that is, mutual recognition of test results, reducing the burden of repeated inspections and tests in different hospitals. One of the prerequisites for realizing "one-pass" is that the quality of IVD reagents must be reliable.
In order to ensure the effectiveness of in vitro diagnostic products, testing institutions should test and evaluate the quality of in vitro diagnostic products. Usually, we will test the accuracy, repeatability, sensitivity, specificity, stability and other indicators of the products.
Taking the accuracy of blood glucose meters and blood glucose test strips as an example, a total of 100 tests were performed on 50 samples with different concentrations using two blood glucose meters.
The accuracy of the in vitro diagnostic product blood glucose meter is evaluated by comparing it with the in vitro diagnostic product glucose analyzer based on the currently recognized "gold standard" enzyme electrode principle in the world.