本文件提供了作为多重分子测试分析物的核酸质量评估的术语和一般要求，多重分子测试同时识别两个或多个感兴趣的核酸靶序列。本文件适用于使用体外诊断（IVD）医疗设备和实验室开发测试（LDT）进行检查的所有多重分子方法。它为核酸靶序列的定性和定量检测提供信息。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.All current amendments available at time of purchase are included with the purchase of this document.