In vitro diagnostics (IVD) are tests or examinations conducted on samples retrieved from the human body such as blood or tissue samples. “In vitro”, meaning “in glass”, indicates that these tests are generally done using equipment like test tubes or petri dishes.
IVD is non-invasive and while some can be used in professional healthcare settings, others can be used at home by consumers.
This article will give an insight into IVD and what it is. It’ll cover the types of IVD tests with some examples, their benefits and the regulations governing these devices. It’ll also provide answers to some frequently asked questions.
Types of In Vitro Diagnostic Devices
There are 2 main types of IVD devices – laboratory-based tests and point-of-care tests.
Laboratory-based tests
For laboratory-based tests, samples are sent to a laboratory for analysis. Often, this is required for complex conditions like cancer, HIV and hepatitis. Other examples of such tests and devices include:
*Blood grouping devices
*Human genetic tests
*Immunoassays
*Next-generation sequencing tests
Point-of-care tests
This type of test is performed at, or near to, the point of patient care. This allows for a quicker diagnosis and speeds up the treatment decision-making process.
In areas with little to no access to laboratory equipment and infrastructure, these point-of-care tests can help to improve patient care and reduce the cost of testing.
Examples of this type of test include:
*Blood glucose self-monitoring systems
*COVID-19 tests
*Pregnancy tests
*Urinalysis test strips
Benefits of In Vitro Diagnostics
IVD is used to monitor an individual’s overall health. It can detect and prevent diseases and other medical conditions; it can also be used in precision medicine to identify the best course of treatment for certain patients. Read on to understand the key benefits of IVD tests.
Early detection of diseases
According to a paper by APACMed regarding diagnostics in healthcare systems, IVD enables patients and/or healthcare providers to detect diseases early. This allows treatment to be administered more promptly and effectively.
For example, IVD tests help with detecting tuberculosis in a quick and accurate manner, and the results are used to make decisions related to the treatment of the disease.
Such diagnostics solutions play a key role in slowing down or preventing the progression of diseases. Liver disease, which is especially prevalent in the Asia-Pacific (APAC) region, is known as a ‘silent killer’ as the condition is often diagnosed after it has deteriorated significantly.
By detecting the disease earlier, complications such as liver cancer can be better managed and even prevented, increasing the chances of survival. In fact, mortality rates of Hepatocellular Carcinoma (HCC), a type of cancer, has been found to decrease by 37% as a result of earlier and more advanced diagnostics.
Prevent the spread of diseases
IVD tests serve as the first line of defense against the spread of diseases. In particular, COVID-19 test kits were used to identify patients with the disease and patients were recommended to quarantine themselves to prevent further spread of the disease.
Additionally, IVD devices are key in preventing the re-emergence of previously eradicated diseases such as smallpox.
Improve patient care and management
With IVD technologies, patients can better understand their condition and make more informed medical decisions. This empowers them to take charge of their overall health and well-being, easing the burden on healthcare institutions by reducing hospital stays and visits to the emergency room (ER).
For healthcare professionals, IVD offers the opportunity to improve patient care as they can make faster, more personalized, and more informed decisions about patients’ treatment plans.
In Vitro Diagnostic Regulations
Globally, IVD devices that are developed and produced for the commercial market are regulated by national authorities to ensure that they’re effective and safe for use.
In most countries, they’re classified based on their potential risk to patients if the diagnosis is inaccurate and the level of control needed to ensure their safety. Based on their classification, devices will have to go through different premarket processes in order to be safely introduced to the market.
In this section, we’ll examine the IVD regulations of the United States (US), Singapore and the APAC region.