Performance of New Liquid Fibrinogen Reagent, Revohem™ FIB LRT on an Automated Blood Coagulation Analyzer CN™-6000

• Performance of New Liquid Fibrinogen Reagent, Revohem™ FIB LRT on an Automated Blood Coagulation Analyzer CN™-6000

AUTHOR(S)

Takahiko BANDOU^*1, Sho SHINOHARA^*4, Jeyachelvi PATHMANATHAN^*4,
Yuta TOTANI^*2, Mai KONO^*2, Tasuku SAKAYORI^*3 and Dunois CLAIRE^*4

*1 Reagent Engineering, Sysmex Corporation
*2 Medical Affairs 2, Medical & Scientific Affairs, Sysmex Corporation
*3 Application Support, Global Management, Sysmex Corporation
*4 HYPHEN BioMed

SUMMARY

Background: Fibrinogen (FBG) determination testing is one of the most common routine coagulation assays used for evaluating bleeding patients. Typically, FBG determinations are performed using a lyophilized thrombin reagent. Revohem^TM FIB LRT (HYPHEN BioMed, Neuville-sur-Oise, France) is a new reagent that is available in liquid form and ready to use to perform FBG assays.
The purpose of this study is to evaluate the analytical performance of the Revohem FIB LRT reagent for FBG testing using an automated blood coagulation analyzer.

Methods: Analytical performances were performed at an internal laboratory (Sysmex Corporation Technopark, Kobe, Japan) and an external site (Royal Hallamshire Hospital, Sheffield, UK) using an automated blood coagulation analyzer CN^TM-6000 (Sysmex Corporation, Kobe, Japan). These analytical studies included validation of the measurement range (linearity and limit of quantitation), imprecision, interferences, and reagent stability (after opening and on-board the instrument). Accuracy (Method comparison) was determined on real-world patient samples using a previously regulatory-cleared FBG method.

Results: The linearity was reported to be 0.5 to 8.6 g/L. Within-laboratory precision studies demonstrated coefficient of variations (CV) of 2.2 to 4.9%. There was excellent correlation (r = 0.999) compared to FBG determinations using Dade^® Thrombin Reagent (Siemens Healthcare Diagnostics, Inc., Marburg, Germany). On-board the coagulation analyzer, the Revohem FIB LRT reagent was stable between 8–14 days depending on reagent vial size. The open vial stability of Revohem FIB LRT reagent was stable for up to 90 days when maintained at 2–8℃ regardless of reagent vial size.
No interference was noted for triglycerides up to 1,500 mg/dL, hemoglobin up to concentrations of 627 mg/dL, or conjugated bilirubin (Merck & Co., Inc., Rahway, USA) and unconjugated bilirubin (Sigma-Aldrich Co. LCC, St. Louis, USA) up to concentrations of 40 mg/dL.

Conclusion: Revohem FIB LRT, a ready-to-use liquid reagent, demonstrated acceptable analytical performance for FBG measurements. This liquid reagent was demonstrated to be substantially equivalent to an existing, regulatory-approved method for measuring FBG in human plasma.

KEY WORDS

Fibrinogen Clauss Liquid, Ready-to-use, CLSI, CN-6000, Revohem FIB LRT

NOTE(S)

This article is based on current regulatory requirements in EMEA Region. (as of Oct. 2024)
The specifications, performances, and functions described here may be different depending on the regions or the countries due to regulatory, legal and/or local guidelines. For more details, please contact your regional affiliates or distributors.