Analytical Evaluation of Platelet Aggregation Level on a Fully Automated Coagulation Analyzer CN-6000, and a Case Study of an Initial Absorbance of Platelet-rich Plasma

• Analytical Evaluation of Platelet Aggregation Level on a Fully Automated Coagulation Analyzer CN-6000, and a Case Study of an Initial Absorbance of Platelet-rich Plasma

AUTHOR(S)

Tasuku SAKAYORI^*1, Mai EGASHIRA^*2, Kyoko NAKAJIMA^*1, Mai KONO^*1,
Keisuke KITANO^*2 and Yosuke IWASAKI^*3

*1 Medical Affairs 2, Medical & Scientific Affairs, Sysmex Corporation
*2 Reagent Engineering, Sysmex Corporation
*3 Scientific Affairs, Medical & Scientific Affairs, Sysmex Corporation

SUMMARY

Antiplatelet therapy has long been used as a practical treatment to prevent the development of thrombosis disease. The Dual antiplatelet therapy using adenosine diphosphate (ADP) receptor system inhibitors and acetylsalicylic acid (aspirin) has become standard therapy. With the development of stents in recent years, the management of antiplatelet therapy has become increasingly important. To assist in determining the effect of antiplatelet drug therapy, we have developed a scoring system using new parameters ADP-induced platelet aggregation level (APAL) and collagen-induced platelet aggregation level (CPAL) for the purpose of confirming the effect of ADP receptor inhibitors and aspirin respectively. Both APAL and CPAL are available on a fully automated coagulation analyzer CN-6000 (Sysmex Corporation, Kobe, Japan; hereinafter CN-6000, Sysmex). Measurement of platelet aggregation using a fully automated coagulation analyzer is expected to standardize procedures, reduce complexity, and create a more efficient testing option. In this study, we evaluated the within-run precision of APAL and CPAL on the CN-6000. The analyzer is equipped with a new function that automatically dilutes reagents in a stepwise manner providing the final dilution concentration. Additionally, we compared it with the existing instrument, the fully automated coagulation analyzer CS-5100 (Sysmex; hereinafter CS-5100) to provide a side-by-side analysis.

For the within-run precision evaluation, the APAL and CPAL coefficient of variation (CV) were determined using normal and abnormal samples with results of less than 3% and 8%, respectively. Also, excellent correlation results were observed against the CS-5100,
r=0.971 for APAL (n=85) and r=0.994 for CPAL (n=82).

To provide sample information on platelet-rich plasma (PRP), the absorbance of PRP was evaluated using the preparation method recommended by the International Society of Thrombosis and Haemostasis. The normal reference range of PRP absorbance (“mOD”) was calculated at a wavelength of 660 nm. The value ranged from 400.7–786.9 mOD at the starting point of PRP evaluation minus the mOD of platelet-poor plasma (PPP).

Our study showed that the CN-6000 APAL and CPAL are reproducible and well correlated with the existing instrument, CS-5100.Since the CN-6000 is expected to reduce inter-procedural differences by automating reagent dilution steps, it will standardize future platelet aggregation testing.

KEY WORDS

Platelet Aggregation, Light Transmission Aggregometry, CN-6000, Revohem, Automation, Anti-platelet Drug, Platelet Aggregation Level (PAL)

NOTE(S)

This article is based on current regulatory requirements in Japan. (as of February, 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.
This article is translated and republished from the Sysmex Journal Web Vol.24 No.1, 2024. (Japanese)