This standard specifies the classification, requirements, testing methods, labeling, standardization, user manual, packaging, transportation, and storage of the standard immunoassay kit for total thyroxine. This standard is applicable to the reagent kit (hereinafter referred to as the TT kit) for the quantitative determination of total thyroxine (TT) based on the principle of competition method. Immunoassay reagent disk for quantitative determination of TT, including labeling methods such as enzyme labeling, (electrochemiluminescence) labeling, (time-resolved) fluorescence labeling, and microplate, tube, magnetic particle, bead removal, and plastic bead as carriers. This standard is not applicable to the cavity gold mark TT. Test strips, b) labeled with radioactive opioids such as "", are used for immunoassay or immunoassay kits. The following references are essential for the false use of this document. For all reference documents during the birthday period, only the version of the reference period applies to this article. Er is a currently used document, but its latest version (including some modifications) is not applicable to this article. GB/T 191 Packaging, Storage, and Transportation Illustrated Standard 3 points out 1l. The purity analysis kit is divided into enzyme labeled Tl according to different methods. Reagent disk, (electrochemically) labeled with '11'. Reagent disk Yellow light labeled TT. Reagents, etc; According to the different solid-phase carriers, TT can be divided into microporous plate, tubular, magnetic particle, microsphere, and plastic special carriers. Reagent kit; can be divided into manual operation method and instrument automatic operation method TT according to different operation processes. Trial production disc. Requirement 4.1: The appearance and physical inspection reagent kit should have complete virtual components; Both the inner and outer packaging are intact, with clear labels, no leakage of liquid reagents, and the freeze-dried components are loose. If mixed with purified water or other solvents, they should be dissolved within 10 minutes without sediment or flocs. 4.2 Linear within the range of 20.0 ng/mL~240.0 ng/mL, fit with a 1g logit mathematical model or other appropriate mathematical models, and the absolute value of the linear correlation coefficient of the dose-backpropagation curve shall not be less than 0.93 o. Property 1. The lower limit of the meandering boundary shall not be higher than 20.0 ng/mL, and the upper limit of the linear C-boundary shall not be less than 240.0 mg/mL. Property 2: 1 nmol/Lx0.077 7-1 pa/dlL. 1 pu alL × 12. B72 @=1 nmsl/L1 nmai/L. x machine, 776 9m1ag/L, 1 ng/amLx1.000 0 0=1 g/L