The term “in vitro” is a Latin word that means “in glass”. Thus, from a scientific approach, we can say that in vitro terms are used to indicate the procedures carried out outside the human body, specifically in glass apparatus such as Petri dishes, test tubes, etc. in laboratories.
In Vitro Diagnostics Meaning:
In Vitro Diagnostics includes various tests and diagnostic procedures that are performed outside the human body. These tests are useful to diagnose, detect, and monitor various body conditions. The demand for these IVD devices is increasing with the increase in diseases, patient-specific treatment, innovation in medicines, etc.
These IVDs are further classified based on their tests, diagnosis, and the risk associated with the device.
Types Of IVDs Based On Their Diagnostic And Monitoring Tests:
There are many types of IVDs which are divided into two major categories according to their monitoring and diagnosing tests. The following are the types of IVDs explained:
Laboratory-Based Tests:
This category involves IVDs that are used for laboratory tests such as:
- Clinical chemistry: It involves testing biological samples such as blood and urine to measure electrolytes, hormones, body fluids, etc.
- Immunochemistry: It is used to detect infections by detecting the antibodies and antigens in the body.
- Hematology: To measure all the parameters of blood.
- Molecular Diagnostics: Analyse genetic parameters.
Point of Care (POC) Tests:
These are tests that involve self-monitoring of parameters.
- Self-Tests: These involve tests such as glucose testing, pregnancy testing, etc.
- Rapid Tests: These are tests with rapid results such as the COVID-19 test.
Other Types of IVDs:
Other categories of IVDs involve other kinds of IVD-related testing such as
- Urine Tests: To analyze ketone bodies and proteins in the urine sample.
- Coagulation Tests: Analyse the blood clotting time.
Examples Of Some Common IVDs:
Some of the widely used common IVDs are as follows:
- Rapid Antigen Test For COVID-19 Detection:
Used for quick detection of coronavirus presence in the human body. - Urine Test Kit:
It is used to detect ketones, proteins, or certain infectious agents in the urine. - Cholesterol Test Strip:
Used to detect cholesterol levels and predict cardiovascular risk levels. - Cancer Marker Test:
It is used to detect the level of cancer markers, to confirm cancer. - Thyroid Function Test:
It is used to detect thyroid levels in the human body, i.e. T3 and T4 hormone levels. - Pregnancy Test Kit:
It is used to detect the hCG hormone in the body to confirm pregnancy. - Blood Glucose Meter:
To monitor the levels of glucose in the blood and detect the diabetic condition and its severity.
Benefits Of In Vitro Diagnosis:
Treatment monitoring:
Various IVDs can be used to track the patient’s response to treatment. It helps the doctors to analyze the treatment effects on the patient’s body and accordingly plan the future line of treatment.
Blood transfusion:
IVD devices help in the detection of blood groups before blood transfusion, to avoid compatibility issues.
Disease Detection:
The IVD-based tests help to diagnose the disease conditions and its severity in the human body. This helps the doctors to determine the line of treatment.
Cancer Risk Detection:
The IVD device helps to determine the cancer stage in the human body or predict the possibility of developing cancer in the later stages of life.
Allergy Testing:
The allergy tests using IVD help to predict the triggered immune response for certain allergens. This helps to determine the patient’s allergy condition.
Promotes advancements in the Medicare system:
The emergence of various in vitro devices has promoted many advances in the Medicare system. This has led to early detection and accurate treatment of many life-threatening conditions.
Early diagnosis of diseases:
These in vitro devices help in the early detection of various fatal diseases. Early detection helps in effective and accurate treatment. For example, many chronic diseases such as tuberculosis, COVID-19, etc. can be detected early by using in vitro diagnostic tests and treated early.
Prevention of the spread of contagious diseases:
Detection using in vitro devices helps to prevent the spread of contagious diseases. Upon positive results of contagious diseases, the affected people are quarantined, safeguarding the health of healthy people.
Improves patient care:
The use of IVD devices aids in improving patient care. These diagnostics and monitoring tests give a brief overview of the patient’s health condition and help the doctor decide the correct and accurate line of treatment.
Speedy test results:
Unlike the traditional method, the new system of diagnosis using IVD has speeded the diagnosis with instant test results.
High accuracy and precision:
As the IVDs undergo vigorous testing, the accuracy and precision level of the IVD devices is very high. These devices thus have a very low rate of developing false positives and false negatives. This makes healthcare professionals highly rely on test results.
Allows non-invasive testing:
These IVD devices promote non-invasive testing, increasing patient compliance. IVD testing involves monitoring and diagnosis of various human conditions using biological samples such as blood, urine, etc.
Supports personalized medicine:
The in vitro diagnosis helps in preparing customized medicines for patients. As the IVD results in the patient’s body conditions being diagnosed, it helps in customizing medicine for the patient according to his needs.
Promotes cost-effective treatment:
Detection of accurate body conditions using IVD devices helps in the treatment of diagnosed diseases at the right time preventing the prolonged treatment of diseases at the last stage without getting hospitalized, thus reducing the overall cost of the disease treatment.
Some Challenges Encountered By IVDs:
There are some challenges that are encountered by IVDs in the market. They are as follows:
- Financial Barrier: High cost is involved in the development of innovative and highly efficient in vitro diagnostics.
- Cybersecurity: With artificial intelligence used in IVD devices, all the data has been computerized. This has made protecting patient data a critical task.
Advancements In IVDs:
Following are some of the advanced IVDs mentioned below:
Automation: The recent IVDs are working in automatic mode such as Autobio’s clinical chemistry analyzers, which streamline laboratory workflows, reduce human error, and increase throughput.
Multiplex Testing: An example of Multiplex testing is Autobio’s molecular diagnostic systems that can test multiple pathogens all at one time, which has proven to be time-efficient and cost-effective as well.
Liquid Biopsy: One of the most advanced examples of Liquid Biopsy is a non-invasive method that detects cancer biomarkers in blood. This helps in early cancer detection.
Artificial Intelligence: Many recent IVD devices are shown to work on artificial intelligence taking innovation in medical science to the next level. This has been proven to speed up the diagnosis and treatment process.
Digital Pathology: The best example of Digital Pathology is the Digitized tissue analyzer which enhances precision in cancer diagnostics.
Regulations For IVDs:
With the increase in the demand for IVD devices, strict rules and regulations adhere to the use of these devices all over the world. In the US, the FDA sees the regulations of IVD, and in the European Union the In Vitro Diagnostic Regulation (IVDR) sets standards for IVD devices. Whereas, in the Asia-Pacific regions, IVDs are regulated by various country-specific regulatory authorities.
Also Read: IVD Medical Devices Registration & Approval In India
Conclusion:
In vitro diagnostics have proven to be a boon for the healthcare industry, supporting innovation in medicine. The emergence of handy user-friendly IVD devices has helped many patients to keep track of their health conditions and seek medical advice when needed.
Thus, with the increased use of IVD, strict rules and regulations are imposed on their manufacturing and distribution under the State and Central Licensing Authorities. To learn more in detail about the regulations and IVD registration requirements in India, click here.
If you need regulatory assistance in registering your IVD or for its sale, distribution, or post-marketing compliance, contact us today at Artixio.
FAQs:
What is the validity of an approval license for IVDs?
The IVD license is valid for 5 years, which requires renewal before its expiration date.
How does reference country approval help import IVD registration in India?
In India, CDSCO considers approval in reference countries such as the US FDA, EMA, Health Canada, etc. for imported IVDs. This simplifies the approval process for imported IVD devices.
What is predicate device comparison?
Predicate device approval shows that your manufactured IVD has similarities with other already approved IVDs in terms of safety and efficacy. This helps CDSCO to better understand the aspects of your device and speed up the approval process.
How much time does CDSCO take for IVD registration license approval?
The CDSCO on average takes 3-9 months for the IVD registration approval depending upon the risk level of the IVD.
