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

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...

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Bibliographic Details
Published in:BMC research notes 2022-01, Vol.15 (1), p.16-16, Article 16
Main Authors: Moya-Salazar, Jeel, SantaMaria, Bianca M, Moya-Salazar, Marcia M, Rojas-Zumaran, Víctor, Chicoma-Flores, Karina, Contreras-Pulache, Hans
Format: Article
Language:English
Subjects:
Cross-Sectional Studies
Cytomegalovirus
Enzyme-linked immunosorbent assay
Enzymes
Female
Humans
Immunoglobulin G
Immunoglobulin M
Immunology
Infant, Newborn
Infants (Newborn)
Infectious diseases
Laboratories
Low income groups
Medical care
Medical examination
Methods
Neonates
Peru
Population
Population studies
Pregnancy
Pregnancy Complications, Infectious
Quality assurance
Quality control
Quality management
Research Note
Rubella
Rubella - diagnosis
Six Sigma
Total Quality Management
Toxoplasma
Toxoplasmosis
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Summary: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. 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.
ISSN:1756-0500
1756-0500
DOI:10.1186/s13104-022-05904-9