Pruebas de generación de Trombina

Coordinador

Dr. Diego Velasco Rodríguez

Hospital Universitario Fundación Jiménez Díaz, Madrid

Participantes

María Marcos-Jubilar², Inés Martínez-Alfonzo¹, Laura Martos³, Carlos Aguilar⁴, Noelia Vilalta⁵, Dolors Llobet⁵, Ana Marco⁶, David Aragoneses⁶, Luciana Ricca⁷, David Ferreira⁸, Sara Lopes⁸, João Mariano-Pego⁹, Ángel Bernardo¹⁰, Antonio Moscardó¹¹, Santiago Bonanad¹¹, Susana Gassiot¹², Isabel Gutiérrez-Jomarrón¹³, Jose Antonio Páramo², Pilar Llamas-Sillero¹, Joan Carles Reverter¹⁴

¹ Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain); ² Clínica Universitaria de Navarra (Pamplona, Spain); ³ Diagnostica Stago S.A.S. (Asnières-sur-Seine, France); ⁴ Hospital Santa Bárbara (Soria, Spain); ⁵ Hospital de la Santa Creu i Sant Pau (Barcelona, Spain); ⁶ Hospital  Universitario General de Alicante (Alicante, Spain); ⁷ Centro Hospitalar Universitário de São João (Porto, Portugal); ⁸ Centro Hospitalar Vila Nova de Gaia/Espinho (Vila Nova de Gaia, Portugal); ⁹ Centro Hospitalar Universitário de Coimbra (Coimbra, Portugal); ¹⁰ Hospital Universitario Central de Asturias (Oviedo, Spain); ¹¹ Hospital Universitario La Fe (Valencia, Spain); ¹² Hospital Sant Joan de Deu (Barcelona, Spain); ¹³  Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Spain); ¹⁴ Hospital Clínic de Barcelona (Barcelona, Spain).

Corresponding author: Diego Velasco-Rodríguez.

Postal address: Department of Hematology. Hospital Universitario Fundación Jiménez Díaz. Avenida Reyes Católicos 2, 28040 Madrid, Spain. Email: diegovelascorodriguez@gmail.com

ABSTRACT

BACKGROUND

The development of fully-automated thrombin generation (TG) assays represents an opportunity for their potential transition from research to routine.

OBJECTIVES

To conduct an interlaboratory comparability study of fully-automated TG, and to establish accurate normal reference intervals for TG parameters in Spanish and Portuguese population.

METHODS

This observational, prospective and multicentric study was conducted at 9 Spanish and 3 Portuguese centers, in two phases. TG was assessed in platelet-poor plasma (PPP) of healthy subjects with the ST-Genesia® analyzer, using the STG‐ThromboScreen® (STG-TS) reagent. In phase I, three different pools were obtained and 3 aliquots of each were sent to all participants. To study repeatability, an aliquot of each pool was analyzed in triplicate on different days and, for precision, the mean of the triplicates between days was analyzed for each laboratory. Accuracy and bias were determined for the three pools separately. In phase II, TG was assessed in at least 30 individuals for each center.

RESULTS

Excellent repeatability was observed for TG parameters, with the exception of velocity index, and adequate intraday precision for each laboratory. Satisfactory performance (z-score ≤ 2) was observed for 96.2% of TG parameters for groups 1 and 2, and 98% for group 3. Most centers showed acceptable relative error for most parameters. Finally, reference ranges for STG-TS stratified by age and sex were determined.

CONCLUSIONS

TG assessment can be performed in a decentralized manner. The Iberian range will serve as a reference to detect if any aspect of the work protocol needs to be revised.