Kashiwagi S, Hayashi J, Noguchi A, Nakashima K, Kishihara Y
Department of General Medicine, Kyushu University Hospital.
Kansenshogaku Zasshi. 1994 Jul;68(7):916-22. doi: 10.11150/kansenshogakuzasshi1970.68.916.
A new immunochromatography assay technique (DAINASCREEN HBsAg, Dainabot) has been recently introduced for the detection of the presence of hepatitis B surface antigen (HBsAg). To evaluate the feasibility of using the DAINASCREEN HBsAg, we carried out comparison tests with this method and RPHA. Results obtained were as follows: In a test of 692 sera from inhabitants in Iki island, Nagasaki Prefecture, 24 (3.5%) were positive for HBsAg by both DAINA and RPHA. Twenty-four patients with hepatitis B were all positive in both methods. Thirty patients with autoimmune diseases and eight who had accidental needle exposure to the blood of patients with HBV infection were negative by both methods. Six individuals were followed over a period of 10 years and all eventually eliminated HBsAg from their sera. In four patients, HBsAg remained positive by DAINA at one yearly check after it had become negative by RPHA. In five patients, HBsAg remained positive by RIA and IMs after DAINA and RPHA had become negative. A good correlation was observed between DAINA and RPHA with a concordance rate of 99.5%. A good correlation of HBsAg titer between the two methods was observed and found to be significant (r = 0.87, p < 0.001). HBsAg assay was able to be completed within 15 minutes by DAINA and the procedure was simple. These results indicate that the sensitivity of DAINA is superior to RPHA and it is easy to use.
最近引入了一种新的免疫层析检测技术（DAINASCREEN HBsAg，戴纳博特公司）用于检测乙型肝炎表面抗原（HBsAg）的存在。为评估使用DAINASCREEN HBsAg的可行性，我们用该方法与反向被动血凝法（RPHA）进行了对比试验。获得的结果如下：在对长崎县壹岐岛居民的692份血清进行的检测中，戴纳法和RPHA检测HBsAg均呈阳性的有24份（3.5%）。24例乙型肝炎患者在两种方法检测中均为阳性。30例自身免疫性疾病患者和8例意外针刺接触HBV感染患者血液的人在两种方法检测中均为阴性。6人随访10年，最终血清中HBsAg均消失。4例患者，RPHA检测变为阴性后，戴纳法每年检查时HBsAg仍为阳性。5例患者，戴纳法和RPHA检测变为阴性后，放射免疫分析法（RIA）和免疫微球法（IMs）检测HBsAg仍为阳性。戴纳法与RPHA之间观察到良好的相关性，符合率为99.5%。两种方法之间观察到HBsAg滴度有良好的相关性，且具有显著性（r = 0.87，p < 0.001）。戴纳法检测HBsAg能够在15分钟内完成，且操作简单。这些结果表明，戴纳法的灵敏度优于RPHA，且易于使用。
