Presepsin 검사의 검체 안정성 평가
Analytical Evaluation of a Presepsin Assay for Specimen Stability
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초록
배경: Presepsin은 코로나바이러스 질병 2019 (COVID-19) 및 급성신장 손상에 대한 예후 표지자로 사용될 수 있다. 이 연구에서는 시료의 안정성을 여러 조건에서 평가하여 Sysmex HISCL-5000 (Sysmex, Japan) presepsin 검사를 수탁검사로 실시하기에 적합한지 확인하였다. 방법: PATHFAST 면역분석기(LSI Medience Corporation, Japan)를이용한 presepsin 검사 후 남은 검체에 대한 시료 안정성을 평가하였다. 총 102개의 검체를 사용하여 5일간의 냉장 보관, CBC 플랫폼을 이용한 혼합 및 전혈의 이송 중 안정성을 평가했다. HISCL presepsin과PATHFAST presepsin 테스트 간의 상관관계는 39개 검체에 대해 평가했다. 결과: 냉장 보관된 혈청 검체는 6시간, 2일 및 5일에 각각 3.6%, 8.05% 및 14.25%의 수치 증가를 보였다(P =0.016). 혈장은 냉장 보관 5일동안 수치 변화가 나타나지 않았다(P =0.14). CBC platform mixer 를 사용한 경우 수기 혼합에 비해 평균값의 증가를 보였다(P< 0.001). 전혈의 이송 및 12시간 이내 원심분리가 이루어진 경우에혈장 이송과 비교하여 차이가 관찰되지 않았다. PATHFAST와HISCL presepsin 검사 간의 상관관계는 매우 우수했다(r=0.9844). 결론: 혈청 검체는 presepsin의 외부 검사실 의뢰에 적합하지 않으며 EDTA 혈장은 냉장 상태에서 5일 동안 안정적인 것으로 나타났다. 검체를 EDTA 전혈로 이송할 경우 12시간 이내에 원심분리가 수행되어야 한다.
Abstract
Background: Presepsin has emerged as a prognostic marker for both coronavirus disease-2019 and acute kidney injury. To assess the feasibility of requesting presepsin tests using Sysmex HISCL-5000 (Sysmex, Japan), we evaluated sample stability under various conditions. Methods: We utilized leftover samples previously analyzed for presepsin using the PATHFAST immune analyzer (LSI Medience Corporation, Japan) to evaluate the stability across four scenarios: five-day cold storage, mixing on a complete blood count (CBC) platform, whole blood transfer, and correlation between HISCL presepsin and PATHFAST tests. A total of 102 specimens were analyzed. Results: Refrigerated serum samples exhibited progressive increases in presepsin levels over five days, with significant rises of 3.6% at six hours, 8.05% at two days, and 14.25% at five days (P =0.016). Conversely, plasma maintained stable levels throughout the five-day cold storage period (P =0.14). Compared to manual invert mixing, CBC platform mixing significantly elevated presepsin values (P <0.001). Notably transferring whole blood followed by centrifugation within 12 hours yielded results comparable to those obtained from plasma. The correlation between HISCL and PATHFAST tests was excellent, with a Pearson correlated coefficient of r=0.9844. Conclusions: Based on our findings, serum samples are unsuitable for laboratory referral of presepsin due to their instability in refrigeration. EDTA plasma, however, exhibits excellent stability for five days under refrigerated conditions. Alternatively, transferring whole blood followed by centrifugation within 12 hours presents a viable option for presepsin testing.
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