检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2014年
5期
521-527
,共7页
薛冰蓉%徐鹏%周玉莲%田小军%阎信宇%苏建蓉%叶平
薛冰蓉%徐鵬%週玉蓮%田小軍%閻信宇%囌建蓉%葉平
설빙용%서붕%주옥련%전소군%염신우%소건용%협평
血液分析仪%全血细胞计数%性能验证
血液分析儀%全血細胞計數%性能驗證
혈액분석의%전혈세포계수%성능험증
Hematology analyzer%Complete blood count%Performance verification
目的：对PENTRA MS60全自动微量血液分析仪（简称PMS60）测定全血细胞计数（CBC）及白细胞（WBC）分类的性能进行评价。方法使用新鲜血样本和仪器配套质控物评价PMS60，验证CBC的本底计数、携带污染率（CR）、精密度[批内、日间变异系数（CV）]、线性范围、准确度，计算PMS60与SYSMEX XS800i血液分析仪（简称XS800i）测定结果的偏差和相关性；以显微镜法为“金标准”，评价PMS60 WBC分类的准确性。结果PMS60测定WBC、红细胞（RBC）、血红蛋白（Hb）和血小板（PLT）的本底计数结果均为“0”。PMS60测定WBC、RBC、Hb 和 PLT 的 CR 分别为0．09％、0．33％、0．54％和0．10％。PMS60测定 RBC、Hb、红细胞压积（HCT）、红细胞平均体积（MCV）、平均红细胞血红蛋白含量（MCH）和平均红细胞血红蛋白浓度（MCHC）的批内CV（正常样本、医学决定水平样本）均＜1．5％，WBC的批内CV分别为0．81％和3．47％，PLT的批内CV分别为3．74％和7．44％；PMS60测定RBC、Hb、HCT、MCV、MCH和MCHC的日间CV（低、中、高水平）均＜2％，WBC的日间CV分别为3．47％、2．99％和2．49％，PLT的日间CV分别为5．28％、4．00％和3．20％。在临床样本所覆盖的浓度范围内，WBC、RBC、Hb和PLT测定值与理论值呈线性相关[相关系数（r）均＞0．998，P均＜0．01]，线性回归方程的斜率均在1．00±0．05范围内。PMS60对5份质控物测定Hb、HCT、MCV、MCH和MCHC的相对偏差均＜3％，WBC＜6．5％、RBC＜3．5％、PLT＜9．5％。PMS60与XS800i对CBC各项目的测定结果偏倚符合率均＞85％（r均＞0．8，P均＜0．01）。PMS60与显微镜法WBC分类计数比较，正常样本的淋巴细胞、单核细胞、中性粒细胞、嗜酸性粒细胞和嗜碱性粒细胞的准确率分别为95％、95％、85％、80％和75％。结论 PMS60性能良好，具有低携带污染率、精密度高、宽线性范围和结果准确可靠的优点，适用于临床常规分析。
目的：對PENTRA MS60全自動微量血液分析儀（簡稱PMS60）測定全血細胞計數（CBC）及白細胞（WBC）分類的性能進行評價。方法使用新鮮血樣本和儀器配套質控物評價PMS60，驗證CBC的本底計數、攜帶汙染率（CR）、精密度[批內、日間變異繫數（CV）]、線性範圍、準確度，計算PMS60與SYSMEX XS800i血液分析儀（簡稱XS800i）測定結果的偏差和相關性；以顯微鏡法為“金標準”，評價PMS60 WBC分類的準確性。結果PMS60測定WBC、紅細胞（RBC）、血紅蛋白（Hb）和血小闆（PLT）的本底計數結果均為“0”。PMS60測定WBC、RBC、Hb 和 PLT 的 CR 分彆為0．09％、0．33％、0．54％和0．10％。PMS60測定 RBC、Hb、紅細胞壓積（HCT）、紅細胞平均體積（MCV）、平均紅細胞血紅蛋白含量（MCH）和平均紅細胞血紅蛋白濃度（MCHC）的批內CV（正常樣本、醫學決定水平樣本）均＜1．5％，WBC的批內CV分彆為0．81％和3．47％，PLT的批內CV分彆為3．74％和7．44％；PMS60測定RBC、Hb、HCT、MCV、MCH和MCHC的日間CV（低、中、高水平）均＜2％，WBC的日間CV分彆為3．47％、2．99％和2．49％，PLT的日間CV分彆為5．28％、4．00％和3．20％。在臨床樣本所覆蓋的濃度範圍內，WBC、RBC、Hb和PLT測定值與理論值呈線性相關[相關繫數（r）均＞0．998，P均＜0．01]，線性迴歸方程的斜率均在1．00±0．05範圍內。PMS60對5份質控物測定Hb、HCT、MCV、MCH和MCHC的相對偏差均＜3％，WBC＜6．5％、RBC＜3．5％、PLT＜9．5％。PMS60與XS800i對CBC各項目的測定結果偏倚符閤率均＞85％（r均＞0．8，P均＜0．01）。PMS60與顯微鏡法WBC分類計數比較，正常樣本的淋巴細胞、單覈細胞、中性粒細胞、嗜痠性粒細胞和嗜堿性粒細胞的準確率分彆為95％、95％、85％、80％和75％。結論 PMS60性能良好，具有低攜帶汙染率、精密度高、寬線性範圍和結果準確可靠的優點，適用于臨床常規分析。
목적：대PENTRA MS60전자동미량혈액분석의（간칭PMS60）측정전혈세포계수（CBC）급백세포（WBC）분류적성능진행평개。방법사용신선혈양본화의기배투질공물평개PMS60，험증CBC적본저계수、휴대오염솔（CR）、정밀도[비내、일간변이계수（CV）]、선성범위、준학도，계산PMS60여SYSMEX XS800i혈액분석의（간칭XS800i）측정결과적편차화상관성；이현미경법위“금표준”，평개PMS60 WBC분류적준학성。결과PMS60측정WBC、홍세포（RBC）、혈홍단백（Hb）화혈소판（PLT）적본저계수결과균위“0”。PMS60측정WBC、RBC、Hb 화 PLT 적 CR 분별위0．09％、0．33％、0．54％화0．10％。PMS60측정 RBC、Hb、홍세포압적（HCT）、홍세포평균체적（MCV）、평균홍세포혈홍단백함량（MCH）화평균홍세포혈홍단백농도（MCHC）적비내CV（정상양본、의학결정수평양본）균＜1．5％，WBC적비내CV분별위0．81％화3．47％，PLT적비내CV분별위3．74％화7．44％；PMS60측정RBC、Hb、HCT、MCV、MCH화MCHC적일간CV（저、중、고수평）균＜2％，WBC적일간CV분별위3．47％、2．99％화2．49％，PLT적일간CV분별위5．28％、4．00％화3．20％。재림상양본소복개적농도범위내，WBC、RBC、Hb화PLT측정치여이론치정선성상관[상관계수（r）균＞0．998，P균＜0．01]，선성회귀방정적사솔균재1．00±0．05범위내。PMS60대5빈질공물측정Hb、HCT、MCV、MCH화MCHC적상대편차균＜3％，WBC＜6．5％、RBC＜3．5％、PLT＜9．5％。PMS60여XS800i대CBC각항목적측정결과편의부합솔균＞85％（r균＞0．8，P균＜0．01）。PMS60여현미경법WBC분류계수비교，정상양본적림파세포、단핵세포、중성립세포、기산성립세포화기감성립세포적준학솔분별위95％、95％、85％、80％화75％。결론 PMS60성능량호，구유저휴대오염솔、정밀도고、관선성범위화결과준학가고적우점，괄용우림상상규분석。
Objective To evaluate the performance of PENTRA MS60 hematology analyzer (PMS60 ) for the determination of complete blood count (CBC ) and white blood cell (WBC ) differential count. Methods The background count,carryover rate (CR),precisions [within-run and inter-day coefficients of variation (CV)],linear range and accuracy of PMS60 were evaluated by fresh blood samples and instrument quality control materials.The bias and correlation of PMS60 and SYSMEX XS800i hematology analyzer(XS800i)were calculated.The microscopy was as a″gold standard″of WBC differential count,and the accuracy of WBC differential count was calculated according to the″gold standard″.Results The background counts of WBC,red blood cell(RBC),hemoglobin(Hb)and platelet(PLT) were all 0.The CR of WBC,RBC,Hb and PLT were 0.09%,0.33%,0.54% and 0.10%.The within-run CV of RBC,Hb,hematocrit(HCT),erythrocyte mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH)and mean corpuscular hemoglobin concentration(MCHC)(normal sample and medical decision level sample)were <1 .5%, the within-run CV of WBC were 0.81% and 3.47%,and the within-run CV of PLT were 3.74% and 7.44%.The inter-day CV of RBC,Hb,HCT,MCV,MCH and MCHC(low,middle and high levels)were <2%,the inter-day CV of WBC were 3.47%,2.99% and 2.49%,and the inter-day CV of PLT were 5.28%,4.00% and 3.20%.Within the concentration range of clinical samples,the correlation coefficients(r)between the measured values and theoretical values of WBC,RBC,Hb and PLT were >0.998(P<0.01).The slope of linear regression equation was in the range of 1.00 ±0.05.The relative biases of Hb,HCT,MCV,MCH and MCHC were <3%,and the relative deviation of WBC,RBC and PLT were <6.5%,<3.5%and <9.5%,respectively.The coincidence rate of the relative deviation for CBC was >85%(r>0.8,P<0.01).Compare to microscopy,the accuracy rates of WBC differential count about lymphocytes,monocytes, granulocytes, eosinophils and basophils were 95%, 95%, 85%, 80% and 75%, respectively.Conclusions The PMS60 has a good performance.It has the advantages of low carryover rate,high precision,wide linear range and reliable accuracy of the results.
