The Basic Evaluation of Light Transmission Platelet Aggregation Method on an Automated Coagulation Analyzer CN-6000

• The Basic Evaluation of Light Transmission Platelet Aggregation Method on an Automated Coagulation Analyzer CN-6000

AUTHOR(S)

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

*1 Protein Technology, Engineering 1, Sysmex Corporation
*2 IVD Clinical Development, Engineering 1, Sysmex Corporation

SUMMARY

Light transmission aggregometry ( LTA ) is known as a gold standard method for assessing platelet function. The fully automated coagulation analyzer CS-5100 ( Sysmex Corporation, Kobe, Japan ) is already enabled to measure platelet aggregation using LTA. It means that a semi-automated aggregometer, which is required only for testing platelet aggregation, and an automated coagulation analyzer for routine testing have been integrated. Moreover, the accuracy of measurement has been improved with the introduction of automated dispensing. Recently, a new automated coagulation analyzer called the CN-6000 ( Sysmex Corporation ) was launched.

In this report, we have evaluated performance of the CN-6000 for platelet aggregation function using 2.0 μM adenosine diphosphate ( ADP ), 2.0 μg/mL of collagen, 5.0 μM epinephrine, 1.0 mM arachidonic acid and 1.2 mg/mL ristocetin. We evaluated within-run precision and onboard stability as compared with the CS-5100 study and reference intervals. Platelet-rich plasma ( PRP ) and Platelet-poor plasma ( PPP ) from healthy volunteers were used as normal samples, and PPP from healthy volunteers, PRP spiked with anti-platelet drugs or artificial PRP were used as abnormal samples.

Within-run precision was measured using 30 replicates of analysis. The coefficient of variation ( CV ) with all agonists tested with normal and abnormal samples was less than 5% and 13%, respectively. The onboard stability evaluation indicated favorable stability up to 10 hours with all agonists. A comparative study between the CN-6000 and the CS-5100 was performed using 130 PRP samples. The CS-5100 showed remarkably high correlation, the correlation coefficient ( r ) with all agonists was more than 0.97. Reference intervals were 59.1%–98.3% for ADP, 80.8%–100% for collagen, 68.8%–99.8% for epinephrine, 63.2%–100% for arachidonic acid, and 77.7%–100% for ristocetin.

The CN-6000 has a reduced footprint by approximately half as compared to the CS-5100, with a reduced processing speed of 12.5% ( 450 tests per 1 hour ) for the PT test. Our results demonstrated that the CN-6000 is a robust automated coagulation analyzer for platelet aggregation testing. It has automatic reagent dilution, which reduces errors in reagent preparation and can be expected to further help standardize testing.

KEY WORDS

Platelet aggregation, Light Transmission Aggregometry, CN-6000, Revohem, Automation

NOTE(S)

This article is based on current regulatory requirements in Japan. ( as of May 2020 )
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.21 No.2, 2020. ( Japanese )