In recent years, various health self-test products, including new crown self-testing agents, have attracted increasing attention. According to Tmall Health's 2023 Double 11 Health Consumption Trend Insight Report, the sales volume of home health testing services has increased significantly compared with the same period in 2022, of which Helicobacter pylori testing has increased by 150%, food intolerance testing has increased by 130%, and young and middle-aged people are the main consumer groups of testing products, with about 60% of consumers between the ages of 25 and 40.
According to the "2024-2030 China In Vitro Diagnostic Reagent Industry Market Management and Development Trend Report" released by Zhiyan Consulting, the market size of China's in vitro diagnostic reagents will be about 139.5 billion yuan in 2022, with a compound growth rate of about 25 from 2015 to 202228%。
In the field of in vitro diagnostics, home self-testing is considered to be a blue ocean with great potential. In addition to traditional blood glucose test strips and early pregnancy (HCG) test strips, consumers can grasp their health status in multiple dimensions without leaving home, from new crown and flu detection to food intolerance, allergen testing, and consumer-based genetic testing.
In winter, respiratory diseases are prevalent, and diseases such as influenza, new crown, and mycoplasma infection all have similar fever and respiratory symptoms, but the drugs for the symptoms are different. From the new crown detection reagents sold online, to the detection reagents for influenza A and B, as well as the nucleic acid amplification tests of various pathogens that need to be sent to institutions after home sampling, patients can reduce the risk of waiting in line and cross-infection in hospitals, and take targeted medication as soon as possible**.
What is the difference between such a convenient at-home test and a hospital test?Are the test results reliable?Can it be used as a reference for diagnosis and medication?Journalists launched an investigation into this.
I also agree with the results of the self-test, but it is necessary to make a diagnosis based on the patient's other clinical manifestations before prescribing. Xu Jinghang, chief physician of the Department of Infectious Diseases of Peking University First Hospital, said that for respiratory infectious diseases, it is feasible for patients to self-test, but it is best to take medication under the guidance of a doctor after getting a positive result.
Xu Jinghang introduced that there are cases of good results in the use of self-testing agents. "A child with fever and respiratory symptoms, as a doctor's parent, purchased a variety of respiratory pathogen on-site testing services on a platform online, and the test result was positive for Streptococcus pneumoniae. After seeing the results, the parents immediately gave the child cefaclor, and the child's body temperature returned to normal on the same day. She said that the self-test kit does help patients save time and travel costs, and reduce the risk of cross-infection in the hospital.
However, due to the non-standard self-sampling of patients and the accuracy of reagents, Xu Jinghang has also encountered individual patients who have shown false negatives and false positives using self-test agents in clinical practice. For example, if an outpatient patient has a fever accompanied by respiratory symptoms, he previously purchased a self-test service and found that he had 3 kinds of viral and bacterial infections, but after the hospital examination, it was found that the blood picture results did not meet the characteristics of bacterial infection, and the doctor judged that the self-tested bacterial positive should be a false positive.
The relevant person in charge of a commercial testing institution said that the company's "six joint tests for respiratory tract infections" are based on PCR nucleic acid detection technology that amplifies sample DNA, which can detect a variety of viruses and Mycoplasma pneumoniae, etc., and needs to send samples back to the institution for testing after home sampling, with an accuracy rate of about 80%. The company itself will also provide testing services for many medical institutions, and the samples from hospitals or individuals are the same testing methods, mainly in whether the sampling end is accurate.
For PCR nucleic acid testing, the preservation of samples is important because the results cannot be displayed in real time, and the samples need to be sent back to the laboratory for testing by professional amplification technology. According to the relevant person in charge of a commercial testing institution, the use of a special preservation solution can ensure that the sample is relatively stable and can be detected smoothly within 7 days, and the sample can be sent back within three days by express delivery to prevent false negative results caused by sample failure.
The reporter's experience found that for the testing items that need to be sent back, after self-sampling, click "one-click call express", and the tester can wait for SF Express to pick up the sample at home and send the sample to the laboratory for testing. The test report can be viewed directly on the mobile phone, which not only saves time and energy, but also protects the privacy of the inspector.
Some patients believe that some samples of various tests performed in the hospital also have to be sent to an outside laboratory, so it is more convenient to take samples directly at home. In this regard, experts believe that the specification of the sampling link is very critical.
Zhao Xiuying, director of the Department of Laboratory Medicine of Beijing Tsinghua Changgung Hospital, introduced that the pathogen spectrum of respiratory tract infections this year is more complex, and in the face of this situation, it is difficult for most hospitals to carry out so many pathogen testing projects in a short period of time, which involves a series of links such as regulations and additions, so the hospital will entrust some testing items to qualified third-party laboratories to meet the needs of clinical diagnosis and treatment, which needs to be carried out under the premise of signing a commissioned inspection agreement and quality assurance. Compared with similar home testing, hospital sampling is standardized by professionals, and home testing should also be standardized, so that the test results can be more referenced.
Industry insiders believe that, on the whole, home self-examination is of positive significance to improve the health management level of the public and promote the early detection of diseases. Zhao Xiuying and other industry insiders believe that home self-testing is mainly divided into two categories: instant presentation of results, also known as point-of-care testing (POCT) and sending samples back to testing institutions after self-sampling, both of which are facing problems such as whether the sampling is standardized and whether the test results are correct. In vitro diagnostic reagents used by consumers themselves, the clinical evaluation shall include the evaluation of the cognitive ability of consumers without medical background on the product instructions, and try to ensure the accuracy of the sampling process. For businesses that provide health self-inspection services, relevant departments should strengthen standardized management, strictly enforce product access, and make every effort to ensure the privacy and security of testers. (Reporter Lin Miaomiao).
*: Economic Information Daily).