What is IVD in medical device?

What IVD means?

The World Health Organization defines in vitro diagnostics (IVDs) as tests that can detect diseases, conditions and infections. In vitro means "in the glass," meaning that these tests are usually performed in test tubes and similar devices, while in vivo tests are performed in the body itself. In vitro tests can be performed in laboratories, medical facilities or even at home. The tests themselves can be performed on a variety of instruments, from small handheld tests to sophisticated laboratory instruments. They allow physicians to effectively diagnose patients and work to provide appropriate treatment.

What is IVD in medical device?

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person's DNA to detect genomic variations. 

IVD Assay Types

According to the classification of testing principles (i.e., the technical path of in vitro diagnostic manufacturers), they can be divided into five categories: biochemical diagnostics, immune diagnostics, molecular diagnostics, blood and body fluid diagnostics, and microbiological diagnostics.

Most in vitro diagnostic assays are developed based on molecular or immunoassay technologies, including polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), chemiluminescent immunoassay (CLIA), lateral flow, cytology, and immunohistochemistry. PCR and its variants are specific and sensitive assays for the identification and amplification of unique DNA/RNA indicating pathogens or disease states fragments.

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