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'''****''' '''TCID50/mL represents the viral load at which 50% of cells are infected when a solution containing the virus is added to the cell culture. The detection limit is expressed in TCID50/mL and copies/TCID50 for H1N1 is 2,3811,048copies/TCID50 corresponding to 1.0510-1TCID50/mL.'''</sub></div>
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)
Knowledge: scientific and technical knowledge required to use the test
Training and experience: training needed to perform the test
Reagents and materials preparation: stability of materials and material preparation
Characteristics of operational steps: complexity of operational steps
Calibration, quality control and proficiently testing materials: can be stable or labile
Test system troubleshooting and equipment maintenance: the easiness and frequency of the troubleshooting and equipment maintenance
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. (https://www.cdc.gov/flu/symptoms/testing.htm)(https://www.cdc.gov/flu/professionals/diagnosis/molecular-assays.htm)
==Safety==