Abstract
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 ± 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.
Publisher
Springer Science and Business Media LLC
Subject
General Biochemistry, Genetics and Molecular Biology,General Medicine
Reference21 articles.
1. Fleischmann-Struzek C, Goldfarb DM, Schlattmann P, Schlapbach LJ, Reinhart K, Kissoon N. The global burden of paediatric and neonatal sepsis: a systematic review. Lancet Respir Med. 2018;6(3):223–30. https://doi.org/10.1016/S2213-2600(18)30063-8.
2. United Nations. The sustainable development goals report. New York: United Nations Publications; 2016.
3. Fleischmann C, Reichert F, Cassini A, Horner R, Harder T, Markwart R, et al. Global incidence and mortality of neonatal sepsis: a systematic review and meta-analysis. Arch Dis Childhood. 2021;106:745–52.
4. Abdel-Fattah SA, Bhat A, Illanes S, Bartha JL, Carrington D. TORCH test for fetal medicine indications: only CMV is necessary in the United Kingdom. Pren Diag. 2005;25(11):1028–31.
5. Moya-Salazar J, Díaz-Rosado RF. Quality analytical planning in blood bank serological screening qualitative assays. Int Clin Pathol J. 2019;7(1):22–6.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献