NADAL®钩端螺旋体IgG/IgM检测试剂盒

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1.预期用途

NADAL®钩端螺旋体IgG/IgM试验是一种横向流动色谱免疫分析法，用于同时检测和鉴别人血清、血浆或全血中的抗问号钩端螺旋体IgG和IgM。该试验旨在用作筛选试验，并作为诊断问号钩端螺旋体（L.interrogans）感染的辅助手段。NADAL®钩端螺旋体IgG/IgM检测结果应采用其他检测方法进行确认。

2.介绍和临床意义钩端螺旋体病发生于世界各地，是人类和动物常见的轻度至重度健康问题，特别是在湿热气候地区。天然水库钩端螺旋体病是啮齿类动物，也是多种家养哺乳动物。人类感染是由五十、 钩端螺旋体属的致病成员。1，2感染通过宿主动物的尿液传播。感染后，钩端螺旋体在血液中存在，直到它们被清除，大约在发病后4到7天，在产生抗问号钩端螺旋体抗体之后。抗钩端螺旋体抗体可在感染后第6天至*0天检测到。它们的水平在3到4周内达到高峰，然后逐渐下降。3种抗体在感染后数年内可检测到。3种抗钩端螺旋体IgM在发病的*周内可检测到，允许在*的时间点进行早期治疗干预。3抗钩端螺旋体IgG出现在感染的晚一个时间点，并可能持续数年。

血清学检测间抗L.interrogans抗体是一种常见的诊断方法。这类检查包括：1）显微凝集试验（MAT）；4 2）酶联免疫吸附试验（ELISA）；5-6 3）间接荧光抗体试验（IFAT）。6通过血液、尿液或脑脊液培养分离钩端螺旋体是确认诊断的有效方法。然而，培养方法只能在感染的早期阶段，即接触后的*周和第2周使用，钩端螺旋体血症在发病的*周结束时结束。3此外，上述方法需要先进的设备和训练有素的技术人员。

NADAL®钩端螺旋体IgG/IgM试验是一种简单的血清学试验，它利用问号钩端螺旋体的抗原并检测抗--五十、 同时介导IgG和IgM。测试可以由未经培训或技能*的人员进行，无需繁琐的实验室设备。结果将在15分钟内公布。

1. Intended Use  The NADAL® Leptospira IgG/IgM Test is a lateral flow chromatographic immunoassay for the  simultaneous detection and differentiation of anti-Leptospira  interrogans IgG and IgM in human serum, plasma or whole blood. The test is intended to be used as a screening test and as an aid in the diagnosis     of     infection     with     Leptospira     interrogans (L. interrogans).

Results obtained with the NADAL® Leptospira IgG/IgM Test should be confirmed with alternative testing method(s).

2. Introduction and Clinical Significance  Leptospirosis occurs worldwide and is a common mild-to- severe health problem for humans and animals, particularly in areas with a hot and humid climate. The natural reservoirs for

leptospirosis are rodents as well as a large variety of domesticated   mammals.    Human    infection   is    caused  by

L. interrogans, the pathogenic member of the genus of Leptospira.^1,2 The infection is transmitted through the urine of the host animal.

After infection, Leptospira are present in the blood until they are cleared, approximately 4 to 7 days after the onset of the disease, following the production of anti-L. interrogans antibodies. Anti-Leptospira antibodies are detectable from the 6th to 10th day after infection. Their levels peak within 3 to 4 weeks and then gradually decline.³ Antibodies may be detectable for several years post-infection.³ Anti-Leptospira IgM are detectable during the first week of illness, allowing early therapeutic intervention at a time point where it is most effective.³ Anti-Leptospira IgG appear at a later time point of infection and may persist for several years.

Serological detection of anti-L. interrogans antibodies is a common diagnostic method. Tests available under this category include: 1) Microscopic agglutination tests (MAT);⁴ 2) ELISA;^5-6 3) Indirect fluorescent antibody tests (IFATs).⁶ Isolation of leptospires by culture of blood, urine or cerebrospinal fluid is an effective method of confirming the diagnosis. However, culture methods can only be applied at an early  stage  of  infection ?  in  the  1st  and  2nd  weeks  after exposure  ? and leptospiremia ends by the end of the first week of illness.³ Moreover, the aforementioned methods require a sophisticated facility and well-trained technicians.

The NADAL® Leptospira IgG/IgM Test is a simple serological test that utilises antigens from L. interrogans and detects anti-

L. interrogans IgG and IgM simultaneously. The test can be performed by untrained or minimally-skilled personnel without cumbersome laboratory equipment. The result is available within 15 minutes.