NON-ISOTOPIC DNA PROBES TO DETECT HTLV-III NUCLEIC ACID

生物技术公司已经开发并正在生产一些产品， 检测人血清中的HTLV-III抗体。 该公司还 开发了用半抗原标记DNA探针的非放射性技术， 从而可以使用酶联抗体检测它们。 此类探针 对于检测感染细胞中的病毒是潜在有用的， 特别是检测人类淋巴细胞中的HTLV-III RNA。 直接 迫切需要对HTLV-III进行测试，以跟进抗体检测 测试，我们估计这种基于DNA探针的试剂盒的潜在市场 大约是每年1000万美元 我们第二阶段的目标是确定 HTLV-III DNA探针测试的最佳格式，将格式包装成 试剂盒和测试实际的试剂盒，为FDA许可做准备。 两种格式， 硝酸纤维素斑点杂交和显微镜原位杂交 幻灯片，将比较灵敏度、性能简单性、时间 要求完成测试，易于解释和容易和成本 制造业 我们认为最好的格式将被纳入 一种或多种尺寸的临床实验室检测试剂盒。 该套件应 仅在第二阶段结束前可用于研究。 年底 在第二阶段，我们预计该试剂盒将准备好进行临床试验。

Biotech has developed and is producing a number of products for the detection of antibodies to HTLV-III in human sera. The company has also developed non-radioactive techniques for tagging DNA probes with haptens, so that they may be detected using enzyme-linked antibodies. Such probes are potentially useful for the detection of viruses in infected cells and specifically the detection of HTLV-III RNA in human lymphocytes. Direct tests for HTLV-III are urgently needed to follow up the antibody detection tests, and we estimate the potential market for such a DNA probe-based kit to be about $10 million per year. Our goals for Phase II are to determine the best format for an HTLV-III DNA probe test, package the format into a kit and test the actual kit in preparation for FDA licensing. Two formats, spot-blots on nitrocellulose and in situ hybridization on microscope slides, will be compared for sensitivity, simplicity of performance, time required to complete the test, ease of interpretation and ease and cost of manufacturing. The format which we judge to be best will be incorporated into a clinical laboratory test kit of one or more sizes. The kit should be available for research use only before the end of Phase II. At the end of Phase II, we expect the kit to be ready for clinical trials.