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

Citation metadata

From: BMC Research Notes(Vol. 15, Issue 1)
Publisher: BioMed Central Ltd.
Document Type: Report
Length: 2,335 words
Lexile Measure: 1470L

Document controls

Main content

Abstract :

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 [+ or -] 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 [+ or -] 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. Keywords: Six sigma, Toxoplasma, Quality assurance, Cytomegalovirus, Quality management, Enzyme-linked immunosorbent assay

Source Citation

Source Citation   

Gale Document Number: GALE|A693699639