Sysmex Journal International

2022Vol.32 No.2

Republished

A Basic Evaluation of LIASAUTO™ P-FDP and LIASAUTO™ D-dimer Neo in the Automated Blood Coagulation Analyzer CN-6000

AUTHOR(S)

Risa MAEDA, Ayako MAKI, Meri KUBOTA and Naofumi OSAKA

Department of Laboratory Medicine, Osaka Medical and Pharmaceutical University Hospital

SUMMARY

Fibrin-fibrinogen degradation products (FDP) and fibrin degradation products (D-dimer or DD) are used in routine clinical laboratory testing for diagnoses of thrombosis and disseminated intravascular coagulation (DIC) and monitoring their course of treatment. In this study, we performed a basic evaluation of the LIASAUTOTM P-FDP (LiaFDP; Sysmex Corporation, Kobe Japan) and the LIASAUTOTM D-dimer Neo (LiaDD; Sysmex) in the automated blood coagulation analyzer CN-6000 (CN-6000; Sysmex). Evaluation results were compared to those of reference reagents in patients with abnormal levels of FDP.

The performance of within-run precision, linearity, limit of detection, and interference was acceptable, and had sufficient performance for daily use.

Regarding correlation with the reference reagent, good correlation was obtained for both FDP and DD, with noted discrepancies. In FDP, the reagents studied tended to be higher or lower than the reference reagent, which was caused by the difference in the reactivity of the antibodies used for both reagents to each fraction of fibrin/fibrinogen degradation product. In DD, there was a discrepancy in which the reagents studied also tended to be higher than reference reagent, which was caused by the difference in the reactivity of the antibodies used in both reagents to the small molecule DD/E fraction.

The reactivity of both reagents was almost the same in both cases of DIC with suppressed fibrinolysis due to sepsis and enhanced fibrinolysis with acute promyelocytic leukemia. We believe the degree of fibrinolytic activation can be estimated by observing the balance of LiaFDP and LiaDD.

FDP and DD may differ in reactivity between reagents and should be used with a full understanding of the reactivity of the reagents used.

KEY WORDS

Fibrin and Fibrinogen Degradation Products (FDP), Fibrin Degradation Products (D-Dimer), CN-6000

NOTE(S)

This article is based on current regulatory requirements in Japan. (as of June, 2022)
The specifications, performances and functions described here may be different depending on the regions or the countries due to the regulatory affairs, legal matters or local guidelines. For more details, please contact your regional affiliates or distributors.
This article is translated and republished from the Sysmex Journal Web Vol.23 No.2, 2022. (Japanese)