Self-testing is a popular type of in vitro diagnostic medical device used for diagnosing infectious disease
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| Self-testing |
The In-vitro Diagnostics
Directive (EU 98/79/EC) governs the performance of self-testing kits. However,
most fall into a lower risk category. In most cases, manufacturers evaluate the
analytical performance of the test, but this is not required for most self-testing
kits.
There are many self-testing
options available. Several COVID-19 testing kits are available over the counter
and can be purchased without a prescription. They can be purchased online, at
retail stores, or from health care providers. This device is an in vitro
diagnostic medical device. It can be used to screen for high blood pressure or
cholesterol levels without the assistance of a healthcare professional. The
device's high accuracy can be compared to lab results and point-of-care tests with
97% accuracy. These devices are gaining high demand due to its ease of use and
accuracy.
The Global
Self-Testing Market is estimated to be valued at US$ 18,503.0 million in 2021 and is expected to exhibit a
CAGR of 8.5% during the forecast
period (2021-2028).
A POC instrument can collect a
blood sample from a fingertip in an office or in the comfort of a patient's
home. The device can also be used by patients who travel. These devices usually
feature a small drop of blood on a test strip. The results are automatically
reported to the patient's physician or can be transmitted via Bluetooth. Some of
these devices have built-in Bluetooth technology, which allows patients to send
their results wirelessly to their healthcare provider. The Hct and Hb values
obtained by these device were similar to those of a professional test. The
results were not affected by sex, age, or time since diagnosis. The device was
easy to use and 92% of patients were satisfied with its results. In addition,
the device was easy to use and 99% of patients were willing to start testing at
home. This has several important implications for the future of healthcare.

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