Question

Explain the significance of CLIA waved testing. DISCUSS CLIA waived microbiology tests that are done in a healthcare setting. Provide examples

Answer 1

Sol:-

CLIA stands for Clinical Laboratory Improvement Amendments. These are certain sets of rules and regulations that needs to be followed by clinical laboratories that are conducting tests or other similar procedures meant for non research purpose.

There are generally 3 categories of testing that includes:-

High, Moderate ad Waived

These tests are classified by the FDA on the basis of several factors that includes the type of equipment used, methodologies adopted and difficulty level of calculation.

Waived test generally refers to the tests that mostly involves the use of simpler methodologies and necessarily do not come under stringent actions. These tests if conducted with accuracy have lesser chance of giving erroneous results. But, if the tests are not performed with precision and precaution then they pose a grave threat to the health as the test result may suggest a change in the medication dose rates.

So, these tests should be conducted by certified personnel only. However, these tests are safer and more affordable.

CLIA waived microbiological tests that are conducted in healthcare settings involve the waived tests done for testing of Streptococcal antigen and for the presence of influenza virus as well. In case of Streptococcal antigen tests, swab are taken from the throat and analysed.In a similar manner rapid Influenza testing are also carried out in healthcare settings.

Some other examples of CLIA waived testing are Glucose test using Glucometer, urine test, cholesterol test and blood test as well.