whether a human sample reacts positive for the item to be tested. Classified as medical devices, RDT includes reagents, test kits, quality control products and other components used for in vitro detection. Human rapid diagnostic test can be used for disease prediction, prevention, diagnosis, and treatment monitoring, as well as prognostic observation and health status evaluation. It can be used alone or in combination with instruments, devices or smart system.
Rapid tests have a wide scope applications and can test a variety of samples like urine, blood, saliva, sweat, serum, and other fluids. They are currently used by clinical laboratories, hospitals, and physicians for quick and accurate tests for specific target molecules and gene expression. Other uses for lateral flow assays are food and environmental safety and veterinary medicine for chemicals such as diseases and toxins. Rapid test kits are also used for disease identification such as COVID-19 Ag.
The reagents used for prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation include in vitro test reagents, kits, calibration products, quality control products and other products.
In China, the term "home self-test" was first proposed by the company Paikun: home self-test (Homelab) can be divided into two types according to the test target. The first category is the family self-examination of diseases, mainly refers to the family medicine model in which people can independently complete some disease detection operations in their own homes according to the instructions. It can be used for self-diagnosis of diseases (infectious diseases, gastrointestinal diseases, female hormone changes, etc.) and therapeutic effect monitoring (tumor marker chemoradiotherapy monitoring, etc.); Another kind is self-checking care family products, including health monitoring (e.g., blood lipid, blood glucose, female genital tract health), bone health, nutritional evaluation (vitamins and minerals), food safety (milk antibiotic residues, clenbuterol pork, etc.) and household environment (such as formaldehyde, allergens, mites), assessment of health interventions, and effects on human health.
Under the IVDR, the first step of compliance certification is to determine the classification of the product under the EU IVDR. Then what are the classification rules of Vitro Diagnostic Medical Devices (IVDR)?
IVDR Classification General Rules:
The use of classification rules should be based on the intended use of the device.
If the device is to be used with other devices, the classification rules shall apply to each device separately.
Accessories in an in vitro diagnostic medical device should be separately classified from the device used in conjunction with it.
Software that drives a device or affects its use should be placed in the same category as the device.
Family self-examination is guided by the theory of general practice, and its basic functions are:
1) Gatekeepers and coordinators of health
Health management companies that provide home self-examination services are aimed at the general public, but their direct customers may be health insurance companies. Home self-examination can avoid excessive medical care and reduce waste: Using the family as the "gateway" between the first doctor and the health care system can effectively reduce unnecessary tests and excessive treatment and avoid waste.
2) Humanized care of "people first"
This way of physical examination can be carried out at home fully reflects the "people-oriented" humanized care, so that the physical examination becomes more warm and willing to accept. Health management companies that provide home self-testing services are also working as friends to fully negotiate and communicate with customers within the scope of medical principles so that individuals can understand and participate in the entire process of testing and decision-making. Many cases, such as pregnancy testing, testing whether children are drug addicts, testing whether they have AIDS, etc., have a certain degree of privacy, and this kind of home self-testing program is more popular among people.
3) Preventive medical care
Home self-examination is prevention-oriented medical care that can be targeted at all stages of health, illness and recovery, and can be at any time, anywhere, and always pay attention to the health of the individual.
Lateral flow collodial gold tests called lateral flow immunochromatographic assays or rapid tests, are simple devices intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. These tests are widely used in medical diagnostics for home testing, point of care testing, or laboratory use. For instance, the home pregnancy test is an rapid test that detects a certain hormone. These tests are simple, economic and generally show results in around five to 30 minutes. Some usage increase the sensitivity of simple by employing additional dedicated equipment.
Rapid point-of-care testsor rule out COVID-19 infection in people with or without COVID-19 symptoms. They:
are portable, so they can be used wherever the patent is ( at the point of care );
are easy to perform, with a minimum amount of extra equipment or complicated preparaton steps;
are less expensive than standard laboratory tests;