ABS-2000全自动血库系统临床应用评价研究

The Estimate for Fully Automated Blood Bank System -ABS2000 in Clinical Transfusion Services

目的:通过相应的测定对自动化血库系统适用性和安全性进行全面评价,并对输血相容性检测方法与常规手工方法进行全面对比。方法:使用人工设计的各种样本对仪器进行特异性、灵敏度及抗干扰试验的对比评估,以及对临床常规9108例标本进行ABO正反定型,Rh(D)测定及抗体筛检测定,并对相应结果进行对比分析。结果:对人工设置的各种测定标本,在特异性、灵敏度和抗干扰试验中,测定结果均能达到设计要求,并优于手工Polybrene方法。ABO血型测定9108份,除正反定型不符228份,报告NTD给予提示外,其它测定血型全部与报告血型相符;Rh(D)所测结果为4份NTD,9104份结果全部相符。抗体筛检测定9108份,抗筛阳性383份,使用同一种抗筛细胞进行手Polybrene方法抗筛测定阳性仅为228份,统计学有显著性意义(P<0.005)。结论:ABS2000应用的固项检测技术具有较高的敏感度,能检测出较弱的IgG类的不规则及自身抗体,以上检测结果及统计情况与国外相关报道情况相符,此仪器在临床检测中使用可以达到保证安全检测的目的。

Objective: A fully estimate for fully automated blood bank system (ABS2000)in safety and applicability ,and compared with those obtained by standard manual methods.Methods: the ABS2000 system uses microtiter plates for determining ABO and Rh(D) types,solid phase red cell adherence assays for antibody detection, to estimate the especially, sensitivity and an-ti-disturb test, and to test the 9108 patients' samples used ABS2000 and standard manual test tube methods. Results: the results in examine the especially, sensitivity and anti-disturb test is fine than standard manual test tube methods,of 9108 patients samples tested for ABO types were concordant for 100% except 228 patients NTD results,tested for D types the result were concordant for 100% except 4 patients NTD results, of 9108 patients'sample tested for antibody screen,There was 383 (4.2%) positive, standard manual test tube methods to test228 ( 2.5% ) positive,(P < 0.005).Conclusions: the ABS2000 system uses solid-phase systems to test ,it have high sensitivity than standard manual test tube methods; for hospital transfusion services ,the ABS2000 offers increased standardization of blood testing .