Diagnostic Comparators
Anti-PGL-1 serology, including NDO-BSA assays, will be used only as a comparator and not as a gold standard. PCR will be treated as a comparator rather than the reference standard when it uses validated primers for M. leprae-specific genom…
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Anti-PGL-1 serology, including NDO-BSA assays, will be used only as a comparator and not as a gold standard. PCR will be treated as a comparator rather than the reference standard when it uses validated primers for M. leprae-specific genomic sequences. Conventional PCR-RLEP and qPCR-RLEP will both be accepted, but sensitivity estimates will be calculated separately. The accepted primary PCR target is the RLEP repetitive element because of its high genomic copy number and superior analytical sensitivity. Anti-PGL-1 antibody titres may reflect past exposure rather than active disease, and diagnostic cutoffs vary across studies.