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Step 5.1 – Develop SOPs
Based on the intended use or uses of the diagnostic test, procedures must be defined, selected, developed or customized for:
- identifying people for whom the test should be performed;
- collecting, processing, storing and transporting specimens to the testing laboratory;
- testing;
- tuberculin injection and induration reading for TB infection skin tests (Annex 4);
- data analysis, security and confidentiality (see Area 6);
- process controls (internal QC) and EQA (see Area 7);
- recording and reporting of results (see Area 8); and
- waste management.
It is essential to have a well-defined, comprehensive set of SOPs that addresses all aspects of the laboratory testing processes, from sample collection to reporting of results; in part, because errors at any step can have a significant impact on the quality of testing. Some SOPs will rely on the manufacturer’s protocols included with commercial kits whereas others will need to be developed. SOPs must be made readily available for staff and must be updated regularly.
Step 5.2 – Update clinical procedures and strengthen the clinical–laboratory interface
A comprehensive plan to implement a new diagnostic test must address all relevant parts of the diagnostic cascade, not just what happens in the laboratory. In addition to laboratory-related SOPs, clear clinical protocols and guidance will be needed for selecting people to be tested, ordering tests, interpreting test results, reporting and making patient-care decisions. Before the introduction of a new diagnostic test or any changes to an existing test, all clinical staff involved in diagnosis and patient management must be informed about the planned changes, and relevant training must be conducted. Information must also be shared with clinical staff at all referral sites through staff training opportunities and through the use of standardized educational materials developed by the NTP. Enhanced clinical trainings should be considered when new tests or testing strategies differ from existing assays in terms of performance or rates of discordant results (e.g. LF-LAM and targeted NGS testing versus LC-aNAAT and phenotypic DST assays).
The rate of ordering of the new test must be monitored, to ensure that the test is being used by the clinical staff at all sites offering the test. Clinical staff at sites with an unexpectedly low or high testing rate may need additional training and sensitization.