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Influenza A

67 bytes added, 19:51, 21 December 2020
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CLIA waived tests are tests cleared for POC setting. These are simple tests with a relatively low risk for an incorrect result. Tests are scored by seven criteria on a scale of one to three, where a score of 1 indicates the lowest level of complexity. The tests may be called CLIA waived, if the score is low enough. The seven criteria are:<ref name="Arti27">Categorization Criteria CLIA test, FDA, 2020, Inc., https://www.fda.gov/node/365445#scorecard</ref>
(Clinical Laboratory Improvement Amendments (CLIA) 2018) 1. Knowledge: scientific and technical knowledge required to use the test2. Training and experience: training needed to perform the test3. Reagents and materials preparation: stability of materials and material preparation 4. Characteristics of operational steps: complexity of operational steps5. Calibration, quality control and proficiently testing materials: can be stable or labile 6. Test system troubleshooting and equipment maintenance: the easiness and frequency of the troubleshooting and equipment maintenance 7. Interpretation and judgement: required to perform analytic processes and resolution of problems An alternative type of testing is with a ‘molecular assay’, which is more accurate than RITDs, because it detects viral RNA or nucleic acids in respiratory specimens. This type of testing includes rapid molecular assays, RT-PCR and other nucleic acid amplification tests. Molecular tests are mostly used in hospitals, some are able to detect both influenza A and B. Others can identify different subtypes. The ‘molecular assays’ are more accurate and sensitive than RIDTs, but the time-to-result may be several hours. <ref name="Arti28">Diagnosing Flu, CDC, 2020, Inc., https://www.cdc.gov/flu/symptoms/testing.htm</ref>  (https://www.cdc.gov/flu/symptoms/testing.htm)(https://www.cdc.gov/flu/professionals/diagnosis/molecular-assays.htm)
==Safety==