The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach.
The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach.
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登革热快速测试测定的诊断灵敏度通过使用组合的抗原和抗体测试方法可显着增强。
DOI：
10.1371/journal.pntd.0001199
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发表时间：
2011-06
影响因子：
3.8
通讯作者：
Cooper MA
中科院分区：
文献类型：
--
作者：
Fry SR;Meyer M;Semple MG;Simmons CP;Sekaran SD;Huang JX;McElnea C;Huang CY;Valks A;Young PR;Cooper MA
IgM和IgG的血清学检测通常用于临床实验室快速诊断登革热，并可以区分原发性和继发性感染。登革病毒非结构蛋白1（NS 1）已被鉴定为急性登革的早期标志物，通常存在于发病后1-9天，但在血清转化后，很难在血清中检测到。评估新开发的Panbio® Dengue Early Rapid检测NS 1的性能，并确定其与商业IgM/IgG快速检测组合使用时是否可以提高诊断灵敏度。在越南进行的一项回顾性研究中，使用198份急性实验室确认的阳性样本和100份阴性样本评价了Dengue Early Rapid的临床性能。在马来西亚，还使用263份实验室确认的阳性和30份阴性样本对登革热早期快速检测与IgM/IgG快速检测相结合的性能进行了评估。在越南，检测的灵敏度和特异性分别为69.2%（95% CI：62.8%至75.6%）和96%（95% CI：92.2%至99.8）。在马来西亚，与RT-PCR相比，性能相似，灵敏度为68.9%（95% CI：61.8%至76.1%），特异性为96.7%（95% CI：82.8%至99.9%）。重要的是，当登革热早期快速检测与IgM/IgG检测结合使用时，灵敏度增加到93.0%。当在发病后每天比较这两种检测时，抗原和抗体标记物之间存在明显差异。这项研究强调，使用登革热NS 1抗原检测结合抗糖蛋白E IgM和IgG血清学可以显着提高急性登革热诊断的灵敏度，并扩展可能的检测窗口，包括非常早期的急性样本，并提高登革热快速免疫层析检测的临床实用性。登革热是一个严重的公共卫生问题，约有30亿人面临感染风险。严重的感染形式可能是致命的，目前没有获得许可的疫苗或有效的治疗方法，早期发现对于协助临床症状管理非常重要。病毒的分离和使用RT-PCR检测病毒RNA是用于早期诊断的常用方法，但耗时、昂贵且需要熟练的操作。快速免疫层析测试（ICT）相对简单，便宜，易于在护理点或附近进行。在这里，我们报告了一种新的快速ICT用于登革热病毒非结构蛋白1（NS 1）的临床表现，这是一种急性感染的标志物。在两个临床研究地点，在60-70%的实验室确认的登革热病例中检测到NS 1，测试的特异性> 95%。我们还表明，与单独检测NS 1相比，循环NS 1抗原和对病毒糖蛋白E的抗体反应的联合检测方法可以显著提高诊断灵敏度。重要的是，结合抗原和抗体检测方法还提供了一个扩大的窗口，从早在发病后第1天的检测。
Serological tests for IgM and IgG are routinely used in clinical laboratories for the rapid diagnosis of dengue and can differentiate between primary and secondary infections. Dengue virus non-structural protein 1 (NS1) has been identified as an early marker for acute dengue, and is typically present between days 1–9 post-onset of illness but following seroconversion it can be difficult to detect in serum. To evaluate the performance of a newly developed Panbio® Dengue Early Rapid test for NS1 and determine if it can improve diagnostic sensitivity when used in combination with a commercial IgM/IgG rapid test. The clinical performance of the Dengue Early Rapid was evaluated in a retrospective study in Vietnam with 198 acute laboratory-confirmed positive and 100 negative samples. The performance of the Dengue Early Rapid in combination with the IgM/IgG Rapid test was also evaluated in Malaysia with 263 laboratory-confirmed positive and 30 negative samples. In Vietnam the sensitivity and specificity of the test was 69.2% (95% CI: 62.8% to 75.6%) and 96% (95% CI: 92.2% to 99.8) respectively. In Malaysia the performance was similar with 68.9% sensitivity (95% CI: 61.8% to 76.1%) and 96.7% specificity (95% CI: 82.8% to 99.9%) compared to RT-PCR. Importantly, when the Dengue Early Rapid test was used in combination with the IgM/IgG test the sensitivity increased to 93.0%. When the two tests were compared at each day post-onset of illness there was clear differentiation between the antigen and antibody markers. This study highlights that using dengue NS1 antigen detection in combination with anti-glycoprotein E IgM and IgG serology can significantly increase the sensitivity of acute dengue diagnosis and extends the possible window of detection to include very early acute samples and enhances the clinical utility of rapid immunochromatographic testing for dengue. Dengue is a serious public health concern with around 3 billion people at risk of infection. Severe forms of the infection can be fatal and with no licensed vaccine or effective therapeutic currently available, early detection is important to assist with the clinical management of symptoms. Isolation of the virus and the detection of viral RNA using RT-PCR are commonly used methods for early diagnosis but are time-consuming, expensive and require skilled operation. Rapid immunochromatographic tests (ICT) are relatively simple, inexpensive and easy to perform at or near the point of care. Here, we report on the clinical performance of a new rapid ICT for the non-structural protein 1 (NS1) of dengue virus, a marker of acute infection. At two clinical study sites, NS1 was detected in 60–70% of laboratory-confirmed dengue cases and specificity of the test was >95%. We have also shown that a combined testing approach for both circulating NS1 antigen and antibody responses to the glycoprotein E of the virus can significantly improve diagnostic sensitivity compared to the detection of NS1 alone. Importantly, the combined antigen and antibody testing approach also provides an expanded window of detection from as early as day 1 post-onset of illness.
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影响因子：
2.9
作者：
Karlsson, R;Katsamba, PS;Myszka, DG
通讯作者：
Myszka, DG
影响因子：
3.8
作者：
Hang VT;Nguyet NM;Trung DT;Tricou V;Yoksan S;Dung NM;Van Ngoc T;Hien TT;Farrar J;Wills B;Simmons CP
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Simmons CP
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通讯作者：
de Vries, Peter J.
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3.1
作者：
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通讯作者：
Chua, K. B.
影响因子：
6.4
作者：
Libraty, DH;Young, PR;Rothman, AL
通讯作者：
Rothman, AL