Six-sigma and quality planning of TORCH tests in the Peruvian population: a single-center cross-sectional study.
BMC Res Notes
; 15(1): 16, 2022 Jan 11.
Article
de En
| MEDLINE
| ID: mdl-35016699
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.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Complications infectieuses de la grossesse
/
Rubéole
/
Toxoplasma
/
Toxoplasmose
Type d'étude:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prevalence_studies
/
Prognostic_studies
/
Risk_factors_studies
Limites:
Female
/
Humans
/
Newborn
/
Pregnancy
Pays/Région comme sujet:
America do sul
/
Peru
Langue:
En
Journal:
BMC Res Notes
Année:
2022
Type de document:
Article
Pays d'affiliation:
Pérou