Dados do Trabalho

Título

Evaluating RT-qPCR for Dengue Virus Detection: Outcomes of a Brazilian External Quality Assessment Program

Introdução

Dengue virus (DENV), poses a substantial public health challenge. While virus isolation is a viable method, RT-qPCR assays yield significantly quicker results. Rapid immunochromatographic tests are available; yet, RT-qPCR matches their sensitivity and provides distinct advantages in clinical laboratory settings. External quality assessment programs (EQAP) play a key role in enhancing laboratory (LAB) diagnostic capabilities by monitoring and assessing diagnostic methods.

Objetivo (s)

To evaluate the diagnostic efficacy of RT-qPCR for DENV using data from an EQAP conducted by a Brazilian provider.

Material e Métodos

The samples comprised lyophilized suspensions containing viable DENV particles, grown on vero cells (BCRJ 0245/ATCC CCL-81) under BSL-3 conditions. From Feb 2017 to Nov 2022, 24 EQAP survey rounds were carried out, each encompassing 3 samples, culminating in 1,153 data points. The evaluation metrics included participant numbers, adequacy percentage (A%), sensitivity (SEN), specificity (SPE), and the incidence of false positives (FP) and false negatives (FN). The RT-qPCR kits employed by participants were classified either as in-vitro diagnostic (IVD) or as laboratory-developed tests (LDT). Kits that demonstrated high performance in terms of A%, SEN, and SPE were identified and listed.

Resultados e Conclusão

Starting with 4 LABs in 2017, the program expanded to 28 by 2022. LAB accuracy presented a median of 99% (97.8% in 2017 and 99.2% in 2022). The Mann-Kendall test indicated a significant trend of increased accuracy (p

Palavras Chave

dengue