Human rapid diagnostic test (RDT) is a medical diagnostic test that is quick and easy to confirm whether the human sample is positive or not. In vitro diagnostic reagents refer to in vitro diagnostic reagents managed according to medical devices, including reagents, kits, calibrators, quality control products and other products used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. It can be used alone or in combination with instruments, appliances, equipment or systems.
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.
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;