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

生物技术公司已经开发并正在为 人血清中HTLV-III抗体的检测该公司还 开发了用半抗原标记DNA探针的非放射性技术， 这样就可以使用酶联抗体来检测它们。这样的探头 对检测受感染细胞中的病毒和 具体地说，检测人淋巴细胞中HTLV-III RNA。直接 迫切需要对HTLV-III进行检测，以跟进抗体检测 测试，我们估计了这种基于DNA探针的试剂盒的潜在市场 每年大约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，请将该格式打包到 试剂盒和测试实际试剂盒，为FDA许可做准备。两种格式， 硝化棉的斑点印迹和显微镜原位杂交 幻灯片，将在灵敏度、性能简单性、时间 完成测试所需的简易性、易用性和成本 制造业。我们认为最好的格式将被合并 一种或多种尺寸的临床实验室检测试剂盒。试剂盒应该 只能在第二阶段结束前用于研究。在结束时 在第二阶段，我们预计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.