Six-sigma and quality planning of TORCH tests in the Peruvian population: a single-center cross-sectional study

• Autores: Moya-Salazar, Jeel, SantaMaria, Bianca M., Moya-Salazar, Marcia M., Rojas-Zumaran, Víctor, Chicoma-Flores, Karina, Contreras-Pulache, Hans
• Formato: artículo
• Fecha de Publicación: 2022
• Institución: Universidad Privada Norbert Wiener
• Repositorio: UWIENER-Institucional
• Lenguaje: inglés
• OAI Identifier: oai:repositorio.uwiener.edu.pe:20.500.13053/6850
• Enlace del recurso: https://hdl.handle.net/20.500.13053/6850; https://doi.org/10.1186/s13104-022-05904-9
• Nivel de acceso: acceso abierto
• Materia: Six sigma; Toxoplasma; Quality assurance; Cytomegalovirus; Quality management; Enzyme-linked immunosorbent assay; http://purl.org/pe-repo/ocde/ford#3.03.00

Objective To ensure the health of newborns, it is necessary to perform high-quality diagnostic tests. The TORCH panel is a set of tests that identifies infectious pathogens such as Toxoplasma (Toxo) and Cytomegalovirus (CMV) that are common in low-setting populations. We performed TORCH panel quality planning using six sigma in a reference laboratory at Peru. Results This was a cross-sectional study. TORCH tests include Toxo, Rubella, CMV, and Herpes. We processed all samples by fourth-generation ELISA on the GEMINI XCR200 analyzer (Diatron, Budapest, Hungary). We obtained the imprecision from the annual data of the external quality assessment plan and we used the CLSI EP12-A3 guideline. In a total of 44,788 analyses, the average imprecision was 3.69 ± 1.47%, and CMV had lower imprecision (2.3 and 2.6% for IgM and IgG, respectively). Quality planning of the TORCH panel allowed estimating the sigma value that ranged from 4 to 10 (average 7 ± 2 sigma), where rubella had the highest values (10 for IgM and 8 for IgG) while HSV2 had the lowest values (4 for IgM and 5 for IgG). Our results suggest the optimal performance of half of the markers including Toxoplasma, Rubella, and CMV in the Peruvian population.