Fourie P B, Swanevelder J P, Lancaster J
National Tuberculosis Research Programme, Medical Research Council, Pretoria.
S Afr Med J. 1996 Feb;86(2):151-4.
The disposable multiple-puncture tuberculin test device, Monotest, was recently introduced in South Africa for tuberculin test screening of tuberculosis infections. Three studies were carried out to compare the intradermal Mantoux test with the Monotest. In the first study, conducted on confirmed hospitalised tuberculosis patients, 307 subjects underwent a 2 TU RT 23 (Statens Seruminstitut, Copenhagen) Mantoux test, 155 a 5 TU test of the same antigen, and 111 a Monotest. In the second study, another group of 98 confirmed tuberculosis patients was double-tested with 5 TU RT 23 by Mantoux test and Monotest. In the first study, 100% of 5 TU Mantoux tests resulted in indurations > or = 5 mm, 97% of 2 TU Mantoux indurations were > or = 10mm, and 96% of Monotests produced indurations > or = 2 mm (manufacturer's recommended cut-off point). In the second study, 99% of the 5 TU Mantoux tests measured > or = 5 mm, and 100% of Monotest indurations were > or = 2 mm. In both studies, raising the cut-off point for the Monotest to > or = 4 mm produced sensitivities of 95% and and 100% respectively. All these tests may therefore be regarded as highly sensitive. In a third study, 58 healthy schoolchildren were double tested with 2 TU RT 23 and with Monotest. Results indicated that if the positivity cut-off point of the Monotest is set a 8 mm instead of at 2 mm, sensitivity suffers slightly, decreasing from 100% to 90%, while specificity increases considerably from 8% to well over 80%. Receiver operating characteristic analysis indicated the high likelihood that the Monotest as well as the Mantoux test could discriminate between infected and uninfected subjects. For both tests the Wilcoxon statistic exceeded 0.8. The Monotest is a useful alternative to the Mantoux test. It is recommended that if tuberculosis is suspected, reaction > or = 4 mm be interpreted as positive. For screening purposes, a cut-off point of 8 mm seems to distinguish best between the infected and the uninfected individual.
一次性多穿刺结核菌素试验装置Monotest最近在南非推出，用于结核病感染的结核菌素试验筛查。开展了三项研究，以比较皮内曼托试验与Monotest。在第一项研究中，对确诊住院的结核病患者进行试验，307名受试者接受了2 TU RT 23（丹麦国家血清研究所，哥本哈根）的曼托试验，155名接受了相同抗原的5 TU试验，111名接受了Monotest。在第二项研究中，另一组98名确诊的结核病患者同时接受了5 TU RT 23的曼托试验和Monotest。在第一项研究中，5 TU曼托试验100%的硬结≥5 mm，2 TU曼托试验97%的硬结≥10 mm，96%的Monotest产生的硬结≥2 mm（制造商推荐的临界点）。在第二项研究中，5 TU曼托试验99%的测量值≥5 mm，Monotest硬结100%≥2 mm。在两项研究中，将Monotest的临界点提高到≥4 mm时，敏感性分别为95%和100%。因此，所有这些试验都可被视为高度敏感。在第三项研究中，58名健康学童同时接受了2 TU RT 23和Monotest测试。结果表明，如果将Monotest的阳性临界点设定为8 mm而非2 mm，敏感性会略有下降，从100%降至90%，而特异性则从8%大幅提高到80%以上。受试者工作特征分析表明，Monotest以及曼托试验很有可能区分感染和未感染的受试者。两项试验的威尔科克森统计量均超过0.8。Monotest是曼托试验的一种有用替代方法。建议如果怀疑患有结核病，将≥4 mm的反应判为阳性。用于筛查目的时，8 mm的临界点似乎最能区分感染和未感染个体。
