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Abstract：
To determine if some patients who tested positive for anti-Scl-70 antibody in clinical practice, but did not have classifiable systemic sclerosis, were negative for anti-Scl-70 antibody by the more specific immunodiffusion method of testing.
Patients evaluated by a rheumatologist at a Scleroderma referral center who had tested positive for anti-Scl-70 antibody prior to referral, but did not have classifiable SSc based on clinical criteria, were invited to undergo testing for anti-Scl-70 antibody by immunodiffusion. Patient demographics and clinical features were recorded at the time of their evaluation, and diagnostic testing results were reviewed using the medical records.
52 patients were enrolled over an 8-year period, with 48 (92.3%) testing negative and 4 (7.7%) testing positive for anti-Scl-70 antibody by immunodiffusion. Of the 48 patients who tested negative, 18 (37.5%) tested negative for ANA by indirect immunofluorescence, 33 (68.8%) did not have Raynaud\'s phenomenon, and 43 (89.6%) had ≤1 clinical criteria items based on the 2013 ACR/EULAR SSc classification criteria. Nevertheless, 21 (43.8%) patients who were negative for anti-Scl-70 antibody by immunodiffusion had undergone a chest CT and 14 (29.2%) had undergone an echocardiogram. A total of 23 patients had at least one follow up clinic visit. 3 out of 4 patients who were positive for anti-Scl-70 antibody by immunodiffusion, but none of the 19 patients who tested negative by immunodiffusion, developed sufficient criteria during follow up to be classified as SSc.
Assays for anti-Scl-70 antibody in commercial laboratories that are commonly utilized in clinical practice can produce false positive results. These results can lead to angst for patients, as well as unnecessary referrals and diagnostic evaluations.
Patients evaluated by a rheumatologist at a Scleroderma referral center who had tested positive for anti-Scl-70 antibody prior to referral, but did not have classifiable SSc based on clinical criteria, were invited to undergo testing for anti-Scl-70 antibody by immunodiffusion. Patient demographics and clinical features were recorded at the time of their evaluation, and diagnostic testing results were reviewed using the medical records.
52 patients were enrolled over an 8-year period, with 48 (92.3%) testing negative and 4 (7.7%) testing positive for anti-Scl-70 antibody by immunodiffusion. Of the 48 patients who tested negative, 18 (37.5%) tested negative for ANA by indirect immunofluorescence, 33 (68.8%) did not have Raynaud\'s phenomenon, and 43 (89.6%) had ≤1 clinical criteria items based on the 2013 ACR/EULAR SSc classification criteria. Nevertheless, 21 (43.8%) patients who were negative for anti-Scl-70 antibody by immunodiffusion had undergone a chest CT and 14 (29.2%) had undergone an echocardiogram. A total of 23 patients had at least one follow up clinic visit. 3 out of 4 patients who were positive for anti-Scl-70 antibody by immunodiffusion, but none of the 19 patients who tested negative by immunodiffusion, developed sufficient criteria during follow up to be classified as SSc.
Assays for anti-Scl-70 antibody in commercial laboratories that are commonly utilized in clinical practice can produce false positive results. These results can lead to angst for patients, as well as unnecessary referrals and diagnostic evaluations.
摘要：
为了确定一些在临床实践中抗Scl-70抗体检测呈阳性的患者，但没有可分类的系统性硬化症，通过更特异性的免疫扩散测试方法，抗Scl-70抗体呈阴性。
由硬皮病转诊中心的风湿病专家评估的患者在转诊前抗Scl-70抗体检测呈阳性，但没有基于临床标准的可分类SSc，被邀请通过免疫扩散进行抗Scl-70抗体的测试。在评估时记录患者的人口统计学和临床特征，和诊断测试结果使用医疗记录进行审查.
在8年的时间里招募了52名患者，其中48例（92.3％）通过免疫扩散检测为阴性，4例（7.7％）通过免疫扩散检测为阳性。在48例检测阴性的病人中,18（37.5％）通过间接免疫荧光检测ANA呈阴性，33人(68.8%)没有雷诺现象，根据2013年ACR/EULARSSc分类标准,有43项(89.6%)的临床标准项目≤1项.然而，通过免疫扩散检测抗Scl-70抗体阴性的21例（43.8％）患者接受了胸部CT检查，14例（29.2％）接受了超声心动图检查。共有23名患者进行了至少一次随访。4例抗Scl-70抗体免疫扩散阳性的患者中有3例，但是19例免疫扩散检测阴性的患者中没有一个，在随访期间制定了足够的标准，将其归类为SSc。
在临床实践中常用的商业实验室中对抗Scl-70抗体的测定可产生假阳性结果。这些结果可能会导致患者焦虑，以及不必要的转诊和诊断评估。
由硬皮病转诊中心的风湿病专家评估的患者在转诊前抗Scl-70抗体检测呈阳性，但没有基于临床标准的可分类SSc，被邀请通过免疫扩散进行抗Scl-70抗体的测试。在评估时记录患者的人口统计学和临床特征，和诊断测试结果使用医疗记录进行审查.
在8年的时间里招募了52名患者，其中48例（92.3％）通过免疫扩散检测为阴性，4例（7.7％）通过免疫扩散检测为阳性。在48例检测阴性的病人中,18（37.5％）通过间接免疫荧光检测ANA呈阴性，33人(68.8%)没有雷诺现象，根据2013年ACR/EULARSSc分类标准,有43项(89.6%)的临床标准项目≤1项.然而，通过免疫扩散检测抗Scl-70抗体阴性的21例（43.8％）患者接受了胸部CT检查，14例（29.2％）接受了超声心动图检查。共有23名患者进行了至少一次随访。4例抗Scl-70抗体免疫扩散阳性的患者中有3例，但是19例免疫扩散检测阴性的患者中没有一个，在随访期间制定了足够的标准，将其归类为SSc。
在临床实践中常用的商业实验室中对抗Scl-70抗体的测定可产生假阳性结果。这些结果可能会导致患者焦虑，以及不必要的转诊和诊断评估。
