EVALUATING PROFICIENCY OF SKIN TESTING

为了在临床上有用，诊断测试需要评估它们的 精确度、精确度和灵敏度。一旦这些测试属性 指定，则可以通过确定人员的熟练程度来评估人员 他们的检测结果是否符合这些规格。这项研究解决了 FDA的ID测试熟练程度方法是否可以修改使用 在实践中。修改后的方法使用了FDA许可的两剂 组胺碱(H)：1.8 mg/ml和0.1 mg/ml。 这两种氢浓度为18(1.8/0.1)。按ID进行的RP测试是 确定如下：终点稀释度和下3个系列3倍 在注射0.05后，测定每个受试者中每种H的稀释度 终点是浓缩物的第一次稀释(稀释#0)。 红斑反应不明显或等于风团。可接受 滴定使红斑反应分级，稀释范围为50 mm 红斑总和(SE)。稀释度#产生45-55 mm的SE或 在两个50 mm范围内的稀释液之间插入的是估计的D50。 每个H的两个估计D50之间的差值是Rp。这个 6个受试者的D50估计值的平均差值为2.5(2~3)。这是 对测试精度的估计。该平均值的标准差较小 然后是0.6。这是对测试精度的估计。平均估计D50 1.8H是6(5.5-7)。0.1H的平均估计D50为4(3-4.5)。这些 后两种方法是测试灵敏度规格。建议的方法 提供了一种在实践中评估ID测试熟练程度的方法。

To be useful clinically, diagnostic tests require evaluation of their accuracy, precision, and sensitivity. Once these test properties have been specified, then personnel can be evaluated for proficiency by determining whether their test results meet these specifications. This study addressed whether an FDA proficiency method for ID testing could be modified for use in practice. The modified method employs two doses of FDA licensed histamine base (H): 1.8 mg/ml and 0.1 mg/ml. The relative potency (RP) of these two H concentrations is 18 (1.8/0.1). The RP by ID test was determined as follows: The endpoint dilution and the next 3 serial 3 fold dilutions of each H were determined in each subject after injection of 0.05 ml. The endpoint was the first dilution from the concentrate (Dilution #0) in which an erythema response was absent or equal to the wheal. Acceptable titrations had graded erythema responses with dilutions bracketing 50 mm sum of erythema (SE). The Dilution# producing a SE between 45-55mm or by interpolating between the 2 dilutions bracketing 50mm is the estimated D50. The difference between the two estimated D50s of each H is the RP. The mean difference in estimated D50 in six subjects is 2.5 (2 to 3). This is the estimate of test accuracy. The standard deviation of this mean is less then 0.6. This is an estimate of test precision. The mean estimated D50 of 1.8H is 6 (5.5-7). The mean estimated D50 of 0.1 H is 4 (3-4.5). These latter two means are test sensitivity specifications. The proposed method provides an approach to assess proficiency of ID testing in practice.