Six‑sigma and quality planning of TORCH tests in the Peruvian population: a single‑center cross‑sectional study
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Date
2022-01-11Author(s)
Moya‑Salazar, Jeel
SantaMaria, Bianca M.
Marcia M. Moya‑Salazar
Rojas‑Zumaran, Víctor
Chicoma‑Flores, Karina
Contreras‑Pulache, Hans
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“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 identifes 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.“
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