Talbot Elizabeth A, Hay Burgess Deborah C, Hone Nicholas M, Iademarco Michael F, Mwasekaga Michael J, Moffat Howard J, Moeti Themba L, Mwansa Ruth A, Letsatsi Pinkie, Gokhale Nandan T, Kenyon Thomas A, Wells Charles D
BOTUSA Project, Gaborone, Botswana.
Clin Infect Dis. 2004 Jul 1;39(1):e1-7. doi: 10.1086/421388. Epub 2004 Jun 14.
A sensitive and accurate tuberculosis (TB) serodiagnostic test would aid in the control of TB, but results of current tests are relatively unreliable for persons infected with human immunodeficiency virus (HIV). We evaluated a new prototype immunochromatographic strip test and 5 commercially available serodiagnostic TB tests in a prospective study comprised of 465 consecutively enrolled patients with suspected TB from 2 hospitals in Botswana. Consenting adults underwent HIV testing, >/=2 sputum smears and cultures, and mycobacterial blood culture. Patients were defined as having TB on the basis of any positive smear or culture. Between January and September 2002, 465 of 498 consecutive patients consented to enrollment. A total of 384 patients (83%) were infected with HIV, and 175 (38%) had TB; the mycobacterial blood culture was the sole source of diagnosis for 26 patients (15%) with TB. Among the tests evaluated, the sensitivity was 0%-63%, the specificity was 39%-99%, the positive predictive value was 0%-39%, and the negative predictive value was 63%-65%. We conclude that the serodiagnostic tests evaluated in this study lacked sufficient sensitivity as sole tests for TB in this population.
一种灵敏且准确的结核病(TB)血清学诊断检测将有助于结核病的防控,但目前的检测结果对于感染人类免疫缺陷病毒(HIV)的人来说相对不可靠。我们在一项前瞻性研究中评估了一种新型免疫层析试纸条检测原型以及5种市售的结核病血清学诊断检测,该研究纳入了来自博茨瓦纳两家医院的465例连续入组的疑似结核病患者。同意参与的成年人接受了HIV检测、≥2次痰涂片和培养以及分枝杆菌血培养。根据任何涂片或培养结果呈阳性来定义患者患有结核病。在2002年1月至9月期间,498例连续患者中有465例同意入组。共有384例患者(83%)感染了HIV,175例(38%)患有结核病;分枝杆菌血培养是26例(15%)结核病患者的唯一诊断依据。在所评估的检测中,灵敏度为0% - 63%,特异性为39% - 99%,阳性预测值为0% - 39%,阴性预测值为63% - 65%。我们得出结论,在本研究中评估的血清学诊断检测作为该人群结核病的唯一检测方法缺乏足够的灵敏度。