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Rapid Tests Kits Under CLIA Regulations

CLIA or Clinical Laboratory Improvement Amendments was passed by the US Congress in 1988 for the establishment of quality standards for all laboratory testing to ensure the accuracy, reliability and timelines of patient test results regardless of there they were done. With a laboratory defines as any facility which performs testing of specimens derived from humans for the purpose of providing information that could help diagnosis, prevention, and treatment of diseases or for general health assessment. CLIA is funded by the user which covers all the administering programs from regulated facilities. It falls under the jurisdiction of the Centers for Medicare and Medicaid Services (CMS) who manages financial management operations of the said regulations. All devices used for testing are tested and approved by the FDA to asses overall design, manufacture and effectiveness. The FDA provides the regulatory categorization of devices such as commercially marketed in-vitro diagnostic tests under CLIA. It has assumed the primary responsibility for performing CLIA complexity categorizations which comes in three groups.

Waived Tests

The first being Waived tests are those tests that have been determined to pose or cause no harm to a patient if it is administered incorrectly. These tests include:

  • 1. Dipstick or reagent urinalysis for the following substances; bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrites, pH, protein, specific gravity, and urobilinogen.
  • 2. Fecal Occult Test IFOB.
  • 3. Ovulation tests that display visual colors for comparison of Luteinizing hormone.
  • 4. Urine pregnancy tests similar to the previous test.
  • 5. Erythrocyte sedimentation.
  • 6. Hemoglobin-copper sulfate.
  • 7. Blood glucose that use FDA Home use Approved devices.
  • 8. spun Microhematocrit.
  • 9. Hemoglobin by single analyte instruments with self-contained components that provides direct measurement and readout.
  • 10.Urine Drug Tests

  • These above tests are waived of the requirements of having to be verified by an approved laboratory and staffed by specialist workers who follow FDA approved test protocol. A comprehensive summary of all approved Waived tests can be obtained from, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm, along with Waived listing of Analytes at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.

    Tests of Moderate Complexity

    Are those that require laboratory or trained personnel for administering and collection and may or may not cause any harm if performed/conducted incorrectly. Some of these moderately categorized tests can be considered waived if it complies with certain exceptions listed under CLIA. People or staff who perform these tests may either me trained or instructed on the proper administering/conducting of these specified tests and the materials being used are considered to be stable without the need for special handling and storage. The complexity of testing is given as a score of 1 to 3, within a list of seven categories, with 1 indicating the lowest complexity. An overall rating that would exceed 12 gives a test the ability to be categorized in the next group due to the sensitivity and complexity of the requirements.

    Tests of High Complexity

    They are the most sensitive sets of tests that need highly specialized equipment, personnel and protocol that is set by the FDA. They are usually the tests done within laboratories that are staffed by people who are either educated or trained on FDA approved protocol and equipment use. They also have to satisfy the seven categories or areas of concern listed below. They are given ratings in the form of scores which are discussed further below.

    (1) Knowledge. Score of 1 a. Minimal scientific and technical knowledge is required to perform the tests b. Knowledge can either be learned through training or through on-the-job instruction. Score of 3 Specialized scientific and technical knowledge is essential to perform pre-analytic, analytic and post-analytic phases of testing

    (2) Training and Experience. Score of 1 a. Minimal training is required for pre-analytic, analytic and post-analytic phases of testing process. b. Limited experience is required to perform the test. Score of 3 Specialized scientific and technical knowledge is essential to perform pre-analytic, analytic and post-analytic phases of testing or substantial experience may be necessary for analytic test performance.

    (3) Reagents and materials preparation. Score of 1 a. Reagents and materials are generally stable and reliable. b. Reagents and materials are pre-packaged or pre-measured and requires no special handling, precautions or storage. Score of 3 a. Reagents and materials are highly labile and may require special handling to assure reliability. b. Reagents and materials preparation may require manual steps such as gravimetric or volumetric measurements.

    (4) Characteristics and Operational Steps. Score of 1 Operational steps are automatically executed (pipetting, temperature monitoring, or timing of steps) or are easily controlled. Score of 3 Operational steps in the testing process requires close monitoring or control, and mat require special specimen preparation, precise temperature control or timing of procedural steps, accurate pipetting or extensive calculations.

    (5) Calibration, quality control and proficiency testing materials. Score of 1 a. Calibrations of materials are stable and readily available. b. Quality control of materials is stable and readily available. c. External proficiency testing materials, when available are stable. Score of 3 a. Calibration materials, if available may be labile. b. Quality control materials may be labile or not available. c. External proficiency testing materials, when available may be labile.

    (6) Test system troubleshooting and equipment maintenance Score of 1 a. Test system troubleshooting is automatic or self-correcting, or clearly described and needs minimal judgment. b. Equipment maintenance is provided by the manufacturer and can be easily performed. Score of 3 a. Test system troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems b. Maintenance requires special knowledge, skills and abilities.

    (7) Interpretation and Judgment Score of 1 a. Minimal interpretation and judgment are required to perform pre-analytic, analytic and post-analytic processes b. Resolution of problems requires limited independent interpretation and judgment. Score of 3 a. Extensive independent interpretation and judgment is required to perform pre-analytic, analytic and post-analytic processes. b. Resolution of problems requires extensive interpretation and judgment.

    These above stated guidelines are the ones used by the FDA in the categorization of test devices. This is essential so as to provide the general public with reliable and accurate test equipment/devices which are implemented today. The results of testing conducted on test devices and procedures are published on the official newsletter of the Federal government to allow manufacturers to review decisions and post comments as needed. The FDA now has an online database of CLIA that contains all relevant information on a specific test system for reference purposes.

    CLIA has provided a standardized approach and categorization of test devices and procedures. They serve to protect the public from non-approved and dubious results for whatever use they may seem fit. It is continuously being improved and revised and can be accessed through the FDA and other complementary agencies.

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