Comparación entre RT-PCR y TMA en la detección de SARS-CoV-2 y propuesta de algoritmo diagnóstico basado en valores de corte

IF 2.2 4区医学 Q3 INFECTIOUS DISEASES

Enfermedades infecciosas y microbiologia clinica Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI:10.1016/j.eimc.2025.503068

Albert Bernet Sánchez , Alba Bellés Bellés , Eric López González , Iván Prats Sanchez , Saray Mormeneo Bayo , María Riesgo Magaña , Mercè García González

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Abstract

Introduction

SARS-CoV-2 caused a pandemic with more than 778 million cases and 7 million deaths. The high diagnostic demand forced laboratories to incorporate new techniques, such as transcription-mediated amplification (TMA). This study compares TMA with RT-PCR in routine clinical samples and evaluates the relationship between relative light units (RLU) and RT-PCR results to define possible cut-off ranges.

Methods

A prospective study was carried out over one year in the microbiology laboratory of Hospital Universitari Arnau de Vilanova de Lleida. All samples for SARS-CoV-2 were processed using TMA (Aptima® Hologic), and a portion was analyzed in parallel with RT-PCR (LightMix®, GeneXpert®, or Cobas®). Concordance between techniques, sensitivity, and specificity were calculated. RT-PCR was considered the reference technique.

Results

A total of 15,156 samples were analyzed with both techniques. Concordance was substantial (κ = 0.692), with a sensitivity of 97.89% and a specificity of 64.74%. Of the results, 11.28% corresponded to false positives and 8.44% to false negatives for TMA. RLU values between 350 and 559, considered negative by the TMA system, were positive by RT-PCR in 20.56%. In intermediate RLU values (560-899), the probability of having a negative RT-PCR was around 50%, dropping to 3.78% for values between 1000 and 1099.

Conclusions

These results support the use of TMA as a screening method, provided the positivity threshold is lowered to 350 RLU and positive cases are confirmed by RT-PCR.

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比较RT-PCR和TMA在SARS-CoV-2检测中的作用以及拟议的基于截断值的诊断算法

sars - cov -2造成了超过7.78亿例病例和700万人死亡的大流行。高诊断需求迫使实验室采用转录介导扩增（TMA）等新技术。本研究将常规临床样本中的TMA与RT-PCR进行比较，并评估相对光单位（relative light units， RLU）与RT-PCR结果之间的关系，以确定可能的截止范围。方法在利莱达市阿尔诺维拉诺瓦医院微生物实验室进行为期一年的前瞻性研究。所有SARS-CoV-2样品均使用TMA （Aptima®Hologic）处理，部分样品与RT-PCR （LightMix®、GeneXpert®或Cobas®）并行分析。计算技术间的一致性、敏感性和特异性。RT-PCR作为参考技术。结果两种方法共分析样品15156份。一致性显著（κ = 0.692），敏感性为97.89%，特异性为64.74%。TMA假阳性11.28%，假阴性8.44%。RLU值在350 ~ 559之间，TMA系统认为为阴性，RT-PCR为阳性的比例为20.56%。在中间RLU值（560-899）中，RT-PCR阴性的概率约为50%，在1000 - 1099之间下降到3.78%。结论在将TMA的阳性阈值降低至350 RLU，并对阳性病例进行RT-PCR确证的情况下，TMA可作为一种筛选方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Enfermedades infecciosas y microbiologia clinica 医学-传染病学

CiteScore

2.10

自引率

8.00%

发文量

194

审稿时长

29 days

期刊介绍： Hoy está universalmente reconocida la renovada y creciente importancia de la patología infecciosa: aparición de nuevos agentes patógenos, de cepas resistentes, de procesos con expresión clínica hasta ahora desconocida, de cuadros de una gran complejidad. Paralelamente, la Microbiología y la Infectología Clínicas han experimentado un gran desarrollo como respuesta al reto planteado por la actual patología infecciosa. Enfermedades Infecciosas y Microbiología Clínica es la Publicación Oficial de la Sociedad Española SEIMC. Cumple con la garantía científica de esta Sociedad, la doble función de difundir trabajos de investigación, tanto clínicos como microbiológicos, referidos a la patología infecciosa, y contribuye a la formación continuada de los interesados en aquella patología mediante artículos orientados a ese fin y elaborados por autores de la mayor calificación invitados por la revista.