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Choosing a Test: Considering Lab or POC Tests
Considering Laboratory or Point-of-Care Tests
Only 1 in 10 hospitals that use rapid HIV tests use them at the point of care. The major considerations for whether to use lab-based tests or point-of-care tests include:
- Logistics in the ED, such as availability of a small space to properly store, run, and read tests
- Availability of trained staff to perform the test
- Capacity of the laboratory to consistently convey rapid HIV test results quickly
If tests are to be run from the laboratory, the lab will likely require additional staff to handle the high volume (if tests are done routinely) and to ensure timeliness of reading and informing providers of results. If tests are to be performed at the point of care, laboratories will be very concerned with providing oversight and ensuring that all point-of-care requirements are met.
Some tests require serum or plasma specimens and can only be performed in the laboratory (e.g., Reveal and Multispot). Tests that use whole blood (e.g., UniGold, Clearview Complete) or oral fluid (e.g., Oraquick Advance) can be performed easily at the point of care by trained personnel.
What is Required for Point-of-Care Tests?
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulates laboratory testing in the United States. The Centers for Medicare and Medicaid Services (CMS) are charged with interpreting CLIA and work closely with the Food and Drug Administration (FDA) and the CDC on their implementation. Some states may have stricter regulations for laboratory testing that make them exempt from CLIA.
CLIA classifies tests according to their complexity. A test may receive a CLIA waiver if it uses direct, unprocessed specimens (such as whole blood or oral fluid) and is easy to perform with little chance of error. Waived tests may be performed outside traditional laboratories by individuals without formal laboratory training. To date, OraQuick ADVANCE, Unigold Recombigen, and Clearview COMPLETE are CLIA-waived; Reveal and Multispot are categorized as moderately complex, which in turn requires that laboratories using those tests adhere to more stringent standards for personnel, quality assurance, and proficiency testing.
Laboratories using waived tests must be registered with the CLIA program. The fee is $150, and it must be renewed every two years. An emergency department can operate as satellite site under another laboratory's CLIA license. Typically, this would be the hospital laboratory's license. Waived laboratories must ensure that all tests performed under their license, including at satellite sites, are used according to manufacturers' instructions and that quality assurance measures are in place (see below).
Click here for more information on registering with CLIA.
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