甲状腺激素检测试剂盒试剂余量对检测结果的影响

The influence of reagent allowance of thyroid hormone detection kit on test results

目的评估甲状腺激素检测试剂盒试剂余量对检测结果的影响。方法分别使用包括TT3、TT4、FT3、FT4和TSH试剂盒(ADVID Centaur XP)在内的每种试剂盒的前10个(Top10)和最后10个测试(End10),采用两套实验方案(方案1:连续5d,每天检测5次;方案2:连续22d,每天检测1次),同时检测2个水平的室内质控品。通过比较两套方案中根据Top10与End10两部分测定结果所计算的变异系数(CV)和两者间的偏差,以及方案2中超出室内质控警戒线和控制线的概率,来判定试剂余量对检测结果的影响。结果(1)于方案1中,对TT3而言,根据其End10结果计算的CV与Top10相比有增高的趋势(水平1:11.0%vs.8.5%;水平2:8.1%vs.7.5%),且End10与Top10间的偏差在几种试剂盒中最大(水平1为6.5%,水平2为5.5%),且这种偏差差异均有统计学意义(P<0.05)。(2)于方案2中,虽然根据TT3之End10结果计算的CV与Top10相比未见增高趋势(水平1:9.8%vs.11.0%;水平2:6.7%vs.7.2%),但使用Top10和End10试剂测定水平1得到的CV(11.0%和9.8%)均超过行业标准(8.3%);End10与Top10之间的偏差在所有项目中也最大(水平1为9.1%,水平2为6.8%),且差异均有统计意义(P<0.05)。(3)在方案2中,虽然使用所有项目的 End10测定两个水平的质控品,其超过警戒线或失控的概率较之Top10差异无统计学意义(均P>0.05),但TT3存在增高的趋势。(4)上述TT3的变化均未在TT4、FT4、FT3和TSH中观察到。结论 TT3测定试剂盒之试剂余量较少时,对其检测结果具有一定的影响。

Objective To evaluate the effect of the reagent allowance of thyroid hormone test kit on the test results.Methods The initial 10 tests,and the last 10 tests of each kit,of the 5 thyroid hormone-related assays（ADVID Centaur XP）,including TT3,TT4,FT3,FT4 and TSH,were used to measure 2 level of IQC products of the above 5 variables,respectively,according to 2 strategies（Strategy 1：each level of IQC was tested for 5 times,for 5 consecutive days;Strategy 2：each level of IQC was tested once per day,for 22 consecutive days）.The coefficient of variance（CV）based on the initial 10 tests and the last 10 tests,and their difference,were compared,in both strategies;in the strategy 2,the probability beyond the warning line and control line was also counted and compared.The initial 10 tests（Top10）and the last 10 tests（End10）of each kit,including TT3,TT4,FT3,FT4 and TSH kit（ADVID Centaur XP）,were used respectively.Two experimental schemes were adopted（scheme 1：5 consecutive days,5 times a day;scheme 2：22 consecutive days,once a day）.Two levels of indoor quality control products were detected simultaneously.By comparing the variation coefficient（CV）calculated by Top10 and End10 and the deviation between them,and the probability of exceeding the indoor quality control warning line and control line in scheme 2,the influence of reagent residue on the test results was determined.Results（1）In scheme 1,for TT3,the CVcalculated from its End10 results tended to increase compared with Top10（level 1：11%vs.8.5%;level 2：8.1%vs.7.5%）and the deviation between End10 and Top10 was the largest in several kits（level 1 was 6.5%,level 2 was 5.5%）with statistical significance（P0.05）.（2）In scheme 2,although the CVcalculated from End10 of TT3 did not show an increasing trend compared with Top10（level：9.8%vs.11%;level 2：6.7%vs.7.2%）,the CV measured by Top10 and End10 reagents（11% vs.9.8%）exceeded the industry standard（8.3%）and the deviation between End10 and Top10 was the largest in all projects（level：9.8%vs.7.2%）.Level 1 was 9.1%and level 2 was 6.8%.The differences were statistically significant（P0.05）.（3）In scheme 2,although End10 of all items was used to measure two levels of quality control products,the increase of the probability of exceeding the warning line or losing control was not significantly compared with Top10（P0.05）,while TT3 showed an increasing trend.（4）The above TT3 changes were not observed in TT4,FT4,FT3 and TSH.ConclusionWhen TT3 assay kit has less reagent allowance,it has a certain impact on the test results.