Evaluation of Reduced Error Rate by Improved Early Reaction Error Function for the Automated Blood Coagulation Analyzer CN™‐6000

• Evaluation of Reduced Error Rate by Improved Early Reaction Error Function for the Automated Blood Coagulation Analyzer CN™‐6000

AUTHOR(S)

Tomoe YAMASHITA^*1, Yoko OKAZAKI^*1, Takamitsu IMANISHI^*1, Yuka TABUCHI^*2,
Hiroshi KURONO^*2, Ryosuke NARISADA^*3, Hironori KATSUMI^*2 and Jun SAEGUSA^*1

*1 Department of clinical laboratory, Kobe University Hospital
*2 System Engineering, Sysmex Corporation
*3 Medical Affairs, Sysmex Corporation

SUMMARY

Activated partial thromboplastin time (APTT) measurements with a biphasic wave showing clear clotting reaction after a primary change in optical turbidity, are seldom observed. The biphasic wave is expected to be a biomarker. On the following automated blood coagulation analyzers CS-5100^TM, CS-2400, CS-2500, CS-2000i , CS-2100i and CS-1600^TM (Sysmex Corporation, Kobe, Japan; hereinafter Sysmex), the Early Reaction Error (ERE) function was implemented to prevent erroneous reporting of clotting times. As a result, a clotting time is not reported when an ERE flag occurs. Therefore, a functional improvement with the analyzers was required to reduce the ERE rate.

On the following automated blood coagulation analyzers CN^TM-3000, CN^TM-6000, CN^TM-3500 and CN^TM-6500 (Sysmex; hereinafter CN^TM-Series), in addition to the conventional ERE function, a new analysis feature was implemented which detects biphasic waves. The two functions were evaluated to study the reduction in the ERE rate.

The automated blood coagulation analyzer CN-6000 was used in this study in addition to Thrombocheck^TM APTT-SLA, Revohem^TM APTT SLA and Actin FSL (all from Sysmex) reagents. Clinical samples were collected at Kobe University Hospital and those with an ERE flag received during routine APTT measurements were utilized in the evaluation. Also, plasma samples spiked with C-Reactive Protein and very low-density lipoprotein to initiate biphasic waves were included in the testing. Correlations were evaluated by the KC4 Delta^TM - semi automated coagulation analyser (DS-MEDICAL inc., Tokyo, Japan; hereinafter KC4 Delta) which utilizes a physical detection method.

The new analysis feature showed an improved ERE rate for all three reagents used. The evaluation results had excellent correlation with the KC4 Delta and confirmed the clotting time calculated by the new analysis feature. This new CN-Series feature is expected to report biphasic wave clotting times which was not reportable on legacy CS analyzers.

KEY WORDS

CN-6000, Optical Detection Method, Activated Partial Thromboplastin Time (APTT), Clot Waveform, Biphasic Waveform

NOTE(S)

This article represents users' experiences with Sysmex solutions. Details on the validated intended use can be found in the Sysmex instructions for use of the corresponding products.
The specifications, performances and functions described here may vary depending on the region or the country due to the regulatory affairs, legal matters, or local guidelines. For more details, please contact your local Sysmex office or distributor.
This article is translated and republished from the Sysmex Journal Web Vol.22 No.2, 2021. (Japanese)