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Additional info for Guidelines for Surveillance of Drug Resistance in Tuberculosis , 4th ed.

Example text

The test results of the NRL should be compared with the coded results of the judicial consensus of the SRLN, which can be considered a “gold standard”. The procedure should be double-blinded. The minimum required agreement should be defined for each drug and should be at least 95% for isoniazid and rifampicin. Sensitivity, specificity, and reproducibility of susceptibility testing are calculated for each of the four first-line drugs tested; a sample analysis sheet is shown in Annex 4A. If an NRL also tests for susceptibility to second-line drugs, an additional analysis sheet is used, as shown in Annex 4B.

Randomization can take place at the level either of diagnostic centres or possibly of health districts. In this way, routines would be slightly changed for some diagnostic centres, for a period of time, but would remain identical for all newly registered smear positive patients in a particular centre. e. weights will not be needed in the analysis. The most useful sampling strategies are described below. 100% sampling of diagnostic centres This sampling method is most suitable for small countries with relatively small numbers of TB diagnostic units, good infrastructure, and facilities to transport samples from all diagnostic centres to the Central Reference Laboratory.

Unless the cluster design effect can be estimated from previous surveys, an effect of 2 should be assumed (which is realistic, but erring on the side of being conservative), and therefore, the calculated sample size obtained from the equation above needs to be multiplied by 2. Finally, the calculated sample size needs to be increased by 15–20% to account for expected losses. Losses include patients diagnosed as smear positive who do not return to the diagnostic centres or do not produce an adequate sample for the survey, patients whose culture is contaminated or does not grow, and patients whose susceptibility testing does not give interpretable results (unreadable or too few colonies).

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