Diagnostic Test Kit Applications

In vitro test reagents, including clinical biotech test kit and rapid diagnostic test kits, have a wide range of applications. These diagnostic tools can quickly and accurately test a variety of samples like blood, urine, saliva, sweat, serum, and other fluids for specific target molecules or gene expression. Clinical laboratories, hospitals, and physicians rely on rapid tests for diagnosis, prevention, treatment monitoring, and prognosis observation.

In addition, lateral flow assays are also used for food and environmental safety and veterinary medicine to identify chemicals such as diseases and toxins. Medical diagnostic kits, such as the COVID-19 Ag, are crucial tools for disease identification and control.

Diagnostic Test Kit Applications

Human rapid diagnostic test (RDT) is a in vitro diagnostic rapid test that quickly and easily confirms 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. It can be used alone or in combination with instruments, devices or smart system.

How Are Home Diagnostic Kits Used

The first category is for family self-examination of diseases, allowing people to independently complete some disease detection operations in their own homes according to the instructions. This can be used for self-diagnosis of various diseases, including infectious diseases, gastrointestinal diseases, and female hormone changes, as well as therapeutic effect monitoring for conditions like tumor marker chemoradiotherapy. The other kind is self-checking care family products, including health monitoring for blood lipid, blood glucose, and female genital tract health, as well as evaluations for bone health, nutritional status for vitamins and minerals, food safety for milk antibiotic residues, clenbuterol pork, and household environment, such as formaldehyde, allergens, and mites. These kits also allow assessment of health interventions and their effects on human health. Frenovo's home diagnostic kits and self-diagnosis kits offer a convenient and reliable way to monitor one's health at home.

How Are Diagnosis Rapid Tests Regulated

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.

Biotech Rapid Test Kit Benefits

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.