Which tests are considered waived under CLIA '88?

Which tests are considered waived under CLIA '88?

• A. Tests that require highly specialized equipment.
• B. Tests that are simple and have a low risk of error, such as dipstick urinalysis and hCG testing.
• C. Tests that are performed only in reference laboratories.
• D. Tests that involve culture-based pathogen identification.

Answer: (B)

Tests waived under CLIA '88 are those that are simple to perform and have a low risk of erroneous results, making them suitable for use in non-traditional lab settings. They are designed for point-of-care use and typically require minimal training and instrumentation. Classic examples include dipstick urinalysis and hCG testing. This simplicity and low risk is what allows these tests to be granted waived status. In contrast, procedures that need highly specialized equipment, are done only in reference laboratories, or involve culture-based pathogen identification are more complex and do not qualify for a waiver. Even waived tests should be performed according to the manufacturer’s instructions with basic quality control to ensure reliable results.

Tests waived under CLIA '88 are those that are simple to perform and have a low risk of erroneous results, making them suitable for use in non-traditional lab settings. They are designed for point-of-care use and typically require minimal training and instrumentation. Classic examples include dipstick urinalysis and hCG testing. This simplicity and low risk is what allows these tests to be granted waived status. In contrast, procedures that need highly specialized equipment, are done only in reference laboratories, or involve culture-based pathogen identification are more complex and do not qualify for a waiver. Even waived tests should be performed according to the manufacturer’s instructions with basic quality control to ensure reliable results.