Borody T J, Andrews P, Shortis N P
Centre for Digestive Diseases, Five Dock, Australia.
Am J Gastroenterol. 1996 Dec;91(12):2509-12.
To evaluate the sensitivity and specificity of a whole blood antibody test (Helisal Rapid Blood test) for the detection of Helicobacter pylori using endoscopic diagnostic criteria of histology and urease tests as the "gold standard."
A prospective trial of Helisal Rapid Blood (HRB) test was carried out in patients undergoing investigations for dyspepsia that included endoscopic biopsy for rapid urease test, microbiological culture, and histology. Blood samples were obtained at the time of endoscopy and were tested for the presence of antibody to H. pylori using the HRB test. In a separate patient group, results of antibody tests in whole venous and capillary blood were compared (n = 25).
The rapid blood test was carried out immediately after the endoscopic examination with a result available in under 10 min in all cases. In 203 patients examined, the HRB test detected 70 of 203 to be H. pylori positive as compared with 71 of 203 using urease/histology. Against combined urease/histology tests, the HRB test achieved 82% sensitivity and 91% specificity. Five patients were judged to be "false negative" on endoscopic tests for H. pylori (extensive intestinal metaplasia n = 3; recent use of antimicrobials) yet the HRB test diagnosed the presence of infection, which could be shown to resolve on treatment. The HRB achieved 89% sensitivity and 91% specificity upon correctly including these five patients in the calculations. In all 25 patients tested, venous and capillary blood results concurred giving HRB test positivity in each case.
Whether using whole venous or capillary blood, the HRB test is a quick, convenient, and accurate test for the diagnosis of active H. pylori infection in patients previously not treated. In a subgroup of patients with low level infection due to recent antimicrobials or intestinal metaplasia negative to all endoscopic tests, the blood test can still correctly diagnose H. pylori infection. Because blood samples require no centrifugation before testing, the greatest usefulness of this test will be that of a primary office diagnostic device.
以内镜组织学诊断标准和尿素酶试验作为“金标准”，评估全血抗体检测（Helisal快速血液检测）对幽门螺杆菌检测的敏感性和特异性。
对因消化不良接受检查的患者进行Helisal快速血液（HRB）检测的前瞻性试验，检查包括用于快速尿素酶试验的内镜活检、微生物培养和组织学检查。在内镜检查时采集血样，使用HRB检测法检测幽门螺杆菌抗体的存在。在另一组患者中，比较了全静脉血和毛细血管血抗体检测的结果（n = 25）。
内镜检查后立即进行快速血液检测，所有病例结果在10分钟内可得。在203例接受检查的患者中，HRB检测法检测出203例中有70例幽门螺杆菌呈阳性，而使用尿素酶/组织学法检测出203例中有71例呈阳性。与联合尿素酶/组织学检测相比，HRB检测法的敏感性为82%，特异性为91%。有5例患者在内镜下幽门螺杆菌检测中被判定为“假阴性”（广泛肠化生n = 3；近期使用过抗菌药物），但HRB检测法诊断为存在感染，经治疗后感染可得到缓解。将这5例患者正确纳入计算后，HRB检测法的敏感性为89%，特异性为91%。在所有检测的25例患者中，静脉血和毛细血管血的结果一致，每种情况下HRB检测法均呈阳性。
无论是使用全静脉血还是毛细血管血，HRB检测法都是一种快速、便捷且准确的检测方法，可用于诊断既往未接受治疗患者的活动性幽门螺杆菌感染。在因近期使用抗菌药物或所有内镜检测均为阴性的肠化生导致感染水平较低的亚组患者中，血液检测仍可正确诊断幽门螺杆菌感染。由于血液样本在检测前无需离心，该检测方法最大的用途将是作为基层医疗机构的主要诊断设备。
