IVDS FOR ANALYSIS TO DETERMINE THE RESULTS OF A SPECIFIC TEST

What is IVD?

In-vitro diagnostics(ivds) are clinical test used for in-vitro examination of specimens derived from the human body to provide information for screening, diagnosis of diseases and other conditions or treatment monitoring purposes. IVDS can be done in laboratories, health care facilities, performed at the point-of-care (POC) or by individuals themselves at home eg: self monitoring of blood glucose, pregnancy test and so on. The tests themselves can be performed on a variety of instruments ranging from small, handheld instrument to complex laboratory instruments. Patients may receive medical care based on diagnostic test results, making it critically important that tests are reliable.

From a patient perspective, the IVDS is not invasive. A sample such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVDS for analysis to determine the results of a specific test. An IVDS analyzes the patient’s sample, not the actual patient. The IVDS focuses on the precision and accuracy of the tested sample.

What is the difference between medical device and IVD?

In-vitro Diagnostics are medical devices and tools used for the purpose of testing samples like blood, urine, and tissues which are taken from the human body in order to detect infections or a medical condition, or to prevent any disease eg: Hepatitis C virus testing, Blood grouping, blood glucose levels, electrolytes testing, genetic testing. Coagulation parameters, renal function test, Molecular testing to name few. Medical devices are the tools or materials which are made to be used on human beings for the purpose of prevention, diagnosis, monitoring, and treatment of diseases or any Injury or physical disorder. These are also used for the process of investigation, replacement or modification of anatomical or physiological process that does not meets its goals through pharmacological, immunological means. For example: Pacemakers, MRI machine, X-ray machine, Ultrasound machines, Hip/ knee implants etc

What are the different types of IVD reagents?

In-vitro diagnostics refer to the products such as reagents, calibrators, quality controls, and so on, intended for use in diagnosis of disease or other conditions. Reagents are solutions of highly-specific biological or chemical substances that are able to react with target substances in the samples. This process will result in a product that can be measured or seen. A calibrator is an instrument or solution of a known measure or quantity that is used to standardize instruments or procedures in the laboratory setting. Quality control is substance or material intended by its manufacturer to be used to verify the performance characteristics of an IVDS medical device.

The following is the classification of In Vitro Diagnostic reagents according to the risk level.

High risk reagents

1. Pathogenic antigen, antibody, nucleic acid testing;

2. Blood type and tissue typing;

3. Human genetic testing;

4. Examination of narcotic drugs, psychotropic drugs and medical toxic drugs;

5. Drug targets testing;

6. Tumor marker testing;

7. Allergy panel

Medium risk reagents

1. Protein;

2. Hormones;

3. Enzymes;

4. Vitamins;

5. Inorganic ions;

6. Drugs and their metabolic by-products;

7. Autoantibodies;

8. drug allergy test;

Low risk reagents

1. Microbial culture medium

2. Sample processing, such as hemolysis reagents, dilution solutions and staining solutions.