Department of Pathology, Hospital Nacional Docente Madre-Niño San Bartolomé, Lima, Peru.
Faculties of Health Science, School of Medicine, Universidad Norbert Wiener, 444 Arequipa Av., 51001, Lima, Peru.
BMC Res Notes. 2022 Jan 11;15(1):16. doi: 10.1186/s13104-022-05904-9.
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.
为了确保新生儿的健康，有必要进行高质量的诊断测试。TORCH 检测是一组针对常见于低置人群的病原体，如弓形虫（Toxo）和巨细胞病毒（CMV）的检测。我们在秘鲁的一家参考实验室使用六西格玛对 TORCH 检测进行了质量规划。
这是一项横断面研究。TORCH 检测包括弓形虫、风疹、CMV 和疱疹。我们使用 GEMINI XCR200 分析仪（Diatron，布达佩斯，匈牙利）上的第四代 ELISA 对所有样本进行处理。我们从外部质量评估计划的年度数据中获得了不精密度，并使用 CLSI EP12-A3 指南。在总共 44788 次分析中，平均不精密度为 3.69±1.47%，CMV 的不精密度较低（IgM 和 IgG 分别为 2.3%和 2.6%）。TORCH 检测的质量规划允许估计西格玛值，范围从 4 到 10（平均 7±2 西格玛），其中风疹的数值最高（IgM 为 10，IgG 为 8），而单纯疱疹病毒 2 的数值最低（IgM 为 4，IgG 为 5）。我们的结果表明，在秘鲁人群中，有一半的标志物（包括弓形虫、风疹和 CMV）的性能最佳。
