Dados do Trabalho

Título

Laboratory Performance in Molecular Detection of Mycobacterium tuberculosis Through Analysis of External Quality Assessment Program Results: WHO-Recommended Tests Outperform Others

Introdução

Tuberculosis (TUB) is a leading cause of death with prompt detection critical. External Quality Assessment Programs (EQAP) ensure the accuracy, reliability, and harmonization of laboratory (LAB) results.

Objetivo (s)

To evaluate the overall performance of participating LABs in 3 EQAP related to TUB organized by a Brazilian provider: M. tuberculosis molecular detection (MTB), Rifampicin resistance detection (RIF), and Isoniazid resistance detection (INH).

Material e Métodos

The EQAP samples were suspensions of human cells, with or without the addition of cultured, inactivated, and lyophilized M. tuberculosis. Labs received 2 samples quarterly for testing accuracy (ACC), sensitivity (SEN), and specificity (SPE). The Mann-Kendall test (MKT) assessed ACC trends over time. Furthermore, kit-type ACCs for in-vitro diagnostic (IVD) vs. laboratory-developed tests (LDT), World Health Organization recommended (WHOR) vs. other kits (non-WHO), and methods (qPCR vs. PCR) were compared.

Resultados e Conclusão

In the MTB EQAP, 63 labs participated over 20 rounds, achieving 96.6% ACC, 97.5% SEN, and 94.9% SPE. The MKT found no significant ACC trends over time (τ = -0.91, p =0.36). IVDs outperformed LDTs with 97.8% vs. 87.9% ACC (OR=6.0, 95%CI 3.42-20.9, p

Palavras Chave

Tuberculose