Teo C G, Gabriel F G, Mortimer P P
PHLS Virus Reference Laboratory, Central Public Health Laboratory, London.
J Clin Pathol. 1992 Oct;45(10):917-20. doi: 10.1136/jcp.45.10.917.
To determine if a scheme for validating enzyme immunoassay (EIA) results could be devised that did not require costly and methodically elaborate supplemental assays.
Samples (n = 525) from patients with haemophilia A, leukaemia, and chronic liver disease and at increased risk of hepatitis C virus infection were tested by EIA-1 (Ortho Diagnostics), an assay which uses recombinant HCV fusion proteins as antigens, and by EIA-2 (United Biomedical), an assay based on synthetic HCV oligopeptide antigens.
Samples (n = 193) were repeatedly reactive in both EIAs. Of these, 190 (98%) yielded reactivities in both of two supplemental assays used, one an immunoblot assay (RIBA) using recombinant HCV polypeptides similar to EIA-1 antigens, and the other a neutralisation EIA (EIA-2N) based on antigenic competition with HCV peptides similar to EIA-2 antigens. The three samples not reactive in supplemental tests exhibited low EIA optical density (OD) values (signal/cutoff ratios of less than 3). Hence, all specimens reactive and yielding high OD values in both EIAs were also reactive in supplemental assays. Twenty four samples were reactive in EIA-1 only and nine (38%) of these were reactive in RIBA. Fourteen of the 15 (93%) specimens reactive in EIA-1 but not RIBA were derived from patients with chronic liver dysfunction. Two samples were reactive in EIA-2 only, of which one was reactive in EIA-2N and none in RIBA.
Compared with EIA-2, EIA-1 yielded more validated reactive samples and resulted in more non-validated reactivities. It is therefore suggested that for clinical diagnosis: (i) EIA-1 be used for anti-HCV testing and EIA-2 for validation of EIA-1 reactivities; (ii) samples concordantly reactive in EIA-1 and EIA-2 and displaying high OD readings be considered HCV antibody positive without supplemental testing; (iii) supplemental testing by RIBA be limited to samples reactive in EIA-1 but equivocal or unreactive in EIA-2 and those concordantly reactive but exhibiting low absorbance readings.
确定是否能够设计出一种验证酶免疫测定（EIA）结果的方案，该方案无需进行昂贵且方法繁琐的补充检测。
采用EIA-1（奥索诊断公司）对来自甲型血友病、白血病和慢性肝病患者且丙型肝炎病毒感染风险增加的样本（n = 525）进行检测，该检测使用重组丙型肝炎病毒融合蛋白作为抗原；同时采用基于合成丙型肝炎病毒寡肽抗原的EIA-2（联合生物医学公司）进行检测。
193份样本在两种EIA检测中均呈反复反应性。其中，190份（98%）在所用的两种补充检测中均呈反应性，一种是使用与EIA-1抗原相似的重组丙型肝炎病毒多肽的免疫印迹检测（RIBA），另一种是基于与EIA-2抗原相似的丙型肝炎病毒肽进行抗原竞争的中和EIA（EIA-2N）。在补充检测中无反应性的3份样本的EIA光密度（OD）值较低（信号/临界值比小于3）。因此，在两种EIA检测中呈反应性且OD值高的所有标本在补充检测中也呈反应性。24份样本仅在EIA-1中呈反应性，其中9份（38%）在RIBA中呈反应性。在EIA-1中呈反应性但在RIBA中无反应性的15份样本中的14份（93%）来自慢性肝功能不全患者。2份样本仅在EIA-2中呈反应性，其中1份在EIA-2N中呈反应性，在RIBA中均无反应性。
与EIA-2相比，EIA-1产生了更多经验证的反应性样本，但也导致了更多未经证实的反应性结果。因此，建议用于临床诊断：（i）使用EIA-1进行抗丙型肝炎病毒检测，使用EIA-2验证EIA-1的反应性；（ii）在EIA-1和EIA-2中均呈一致反应性且OD读数高的样本无需补充检测即可视为丙型肝炎病毒抗体阳性；（iii）RIBA补充检测应限于在EIA-1中呈反应性但在EIA-2中不明确或无反应性的样本，以及呈一致反应性但吸光度读数低的样本。
