钩端螺旋体IgM抗体检测试剂盒

用途：本钩端螺旋体IgM抗体检测试剂盒用于定量检测血液中的钩端螺旋体IgM抗体，初步诊断感染钩端螺旋体。

Intended Use

The Lepto IgM Detect TM  test for exposure to leptospira

species is a rapid assay system for the detection of IgM antibodies in

human blood, plasma/serum to lepto derived multi-epitope

recombinant antigens (LMeRA; 1-6). This test is to aid in the

presumptive diagnosis of human exposure to pathogenic leptospira

species. It is not intended to screen blood or blood components, and

is for research or export use only.

Summary and Explanation

Leptospirosis is a bacterial disease that affects humans and

animals. It is caused by bacteria of the genus Leptospira. In humans

it causes a wide range of symptoms, and some infected persons may

have no symptoms at all. Symptoms of leptospirosis include high

fever, severe headache, chills, muscle aches, and vomiting, and may

include jaundice (yellow skin and eyes), red eyes, abdominal pain,

diarrhea, or a rash. If the disease is not treated, the patient could

develop kidney damage, meningitis (inflammation of the membrane

around the brain and spinal cord), liver failure, and respiratory

distress.

Principle

Lepto IgM Detect™ test for leptospirosis is a qualitative, membrane

based immunoassay intended to be used for the detection of IgM

antibodies in patients’ blood, or plasma/serum developed during

virulent leptospira infection.

The membrane is pre-coated with novel LMeRA on the test

line region (T) and IgM binding protein on the control line region

(C). During testing, the sample reacts with the dye conjugate (IgM

binding protein-colloidal gold conjugate) which has been pre-coated

in the test device. The mixture then migrates upward on the

membrane chromatographically by capillary action to react with

recombinant LMeRA on the membrane and generates red line.

Presence of a test line (T) indicates a positive result, while its absence

indicates a negative result. The unbound conjugate migrates across

the membrane to the immobilized control region, a red line at the

control line region will always appear. The presence of control (C)

validates the assay.

Precautions（注意）

For professional in vitro diagnostic use only. Do not use after

expiration date.

·  Handle all sera and kits used as if they contain infectious agents.

Observe established precautions against microbiological hazards

while performing all procedures and follow the standard

procedures for proper disposal of sera and used kits.

Wear protective clothing, eye protection and disposable gloves

while performing the assay. Wash hands thoroughly when

finished.

·  Avoid all contact between hands and eyes or mucous

membranes during testing.

·  Do not eat, drink or smoke in the area where the sera and kits

are handled.

·  Chase Buffer contains a preservative; avoid all possible contact

with skin and mucous membranes.（钩端螺旋体IgM抗体检测试剂盒）

(我司有人、羊、牛、马、兔和猪等动物细胞因子；植物细胞因子；活性多肽；激素和自身抗体等等ELISA检测试剂盒,还有各种原料和质控品，欢迎来电)

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