He Xiu-yun, Zhuang Yu-hui, Zhang Xiao-gang
Laboratory of Transplantation Center, the 309th Hospital, Chinese People's Liberation Army, Beijing, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2009 Aug;32(8):581-4.
To evaluate the potential of recombinant 38000 protein of Mycobacterium tuberculosis (38000 protein) as a tuberculosis-specific tuberculin for screening M. tuberculosis infection.
A total of 1342 subjects (706 men and 636 women, age 18-60 years) from several communities in Kazuo County and Xidaziying Town, Chaoyang, Liaoning Province, and Hongdong County, Linfen, Shanxi Province were enrolled from September 2004 to February 2005. The skin tests were performed with double-blinded and the intradermal injections were administered on both forearms with 0.1 ml solution of PPD and 38000 protein at the right side and the left side, respectively. The vertical and transverse diameters of induration or erythema were measured following 24 h for 38000 protein and 48 h for PPD, respectively. The diameters of the the skin test reactions were defined as the means of the vertical and transverse diameters, and positive skin reactions were identified when the diameter was greater than or equal to 5 mm. The comparison of the positive rate was performed via chi(2) test and the consistency of positive skin test reactions between 38000 protein and TB-PPD was analyzed through calculating Kappa coefficients.
The positive rate was 55.1% (740/1342) and 28.6% (384/1342) for PPD and 38000 protein, respectively; the difference being significant (chi(2) = 190.6, P < 0.01). The consistency of positive skin test reactions between 38000 protein and PPD was low due to a negative Kappa coefficient. The positive rates induced by PPD and 38000 protein tended to increase with age except for the 33-37 year group. For a given age group, the positive rate of PPD was much higher than that of 38000 protein. The subjects without BCG scar had a lower positive rate for 38000 protein (24.3%, 137/566) than those with BCG scar (31.9%, 247/776) (chi(2) = 4.7, P < 0.05). The subjects with tuberculosis contact history had a higher positive rate for 38000 protein (74.4%, 32/43) than those without tuberculosis contact history (27.1%, 352/1299). Subjects without tuberculosis contact history had a lower positive rate for 38000 protein (27.1%, 352/1299) than that of PPD (54.0%, 702/1299), all of which showed significant difference (chi(2) test values changed from 4.7 to 192.1, P < 0.05 or P < 0.01). For those with a tuberculosis contact history, no significant difference in the positive rate was found between 38000 protein (74.4%, 32/43) and PPD (88.4%, 38/43) (chi(2) = 1.9, P > 0.05). Nor was significant difference found in the positive rate of 38000 protein between male subjects (28.5%, 201/706) and female subjects (28.8%, 183/636). The diameter of the positive reactions induced by 38000 protein and PPD ranged from 5 - 9 mm and from 5 - 14 mm, respectively.
Our findings show that 38000 protein may be useful as a tuberculosis-specific skin test antigen for screening Mycobacterium tuberculosis infection.
评估结核分枝杆菌重组38000蛋白（38000蛋白）作为结核病特异性结核菌素用于筛查结核分枝杆菌感染的潜力。
2004年9月至2005年2月，从辽宁省朝阳市喀左县和西大营子镇、山西省临汾市洪洞县的几个社区招募了1342名受试者（706名男性和636名女性，年龄18 - 60岁）。皮肤试验采用双盲法，分别在双侧前臂皮内注射0.1 ml PPD溶液和38000蛋白溶液。38000蛋白注射后24小时、PPD注射后48小时分别测量硬结或红斑的垂直和横径。皮肤试验反应直径定义为垂直和横径的平均值，直径大于或等于5 mm时判定为皮肤反应阳性。阳性率比较采用χ²检验，通过计算Kappa系数分析38000蛋白与结核菌素纯蛋白衍生物（TB - PPD）皮肤试验阳性反应的一致性。
PPD和38000蛋白的阳性率分别为55.1%（740/1342）和28.6%（384/1342）；差异有统计学意义（χ² = 190.6，P < 0.01）。由于Kappa系数为阴性，38000蛋白与PPD皮肤试验阳性反应的一致性较低。除33 - 37岁组外，PPD和38000蛋白诱导的阳性率随年龄增长呈上升趋势。对于给定年龄组，PPD的阳性率远高于38000蛋白。未接种卡介苗的受试者38000蛋白阳性率（24.3%，137/566）低于接种卡介苗的受试者（31.9%，247/776）（χ² = 4.7，P < 0.05）。有结核接触史的受试者38000蛋白阳性率（74.4%，32/43）高于无结核接触史的受试者（27.1%，352/1299）。无结核接触史的受试者38000蛋白阳性率（27.1%，352/1299）低于PPD阳性率（54.0%，702/1299），差异均有统计学意义（χ²检验值从4.7到192.1，P < 0.05或P < 0.01）。对于有结核接触史的受试者，38000蛋白阳性率（74.4%，32/43）与PPD阳性率（88.4%，38/43）相比差异无统计学意义（χ² = 1.9，P > 0.05）。38000蛋白在男性受试者（28.5%，201/706）和女性受试者（28.8%，183/636）中的阳性率差异也无统计学意义。38000蛋白和PPD诱导的阳性反应直径分别为5 - 9 mm和5 - 14 mm。
我们的研究结果表明，38000蛋白可能作为一种结核病特异性皮肤试验抗原用于筛查结核分枝杆菌感染。
